Trial Outcomes & Findings for A Study to Assess Efficacy and Safety of HL036 in Subjects With Dry Eyes (NCT NCT03846453)
NCT ID: NCT03846453
Last Updated: 2022-04-14
Results Overview
It was evaluated for the inferior region on the Ora Calibra® and Conjunctival staining scale. The score ranges from 0 to 4 (0=none and 4=severe), and lower score indicates improvement. Change score from pre- to post-CAE® was calculated as post-CAE® score - pre-CAE® score.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
637 participants
Primary outcome timeframe
Pre-CAE and Post-CAE on Day 1 (Baseline) and Day 57
Results posted on
2022-04-14
Participant Flow
Participants who met all the eligibility criteria were enrolled at 12 sites in the United States.
A total of 1108 patients were screened and 637 patients were enrolled and randomized to one of the treatment groups. The enrollment number in Protocol refers to the participants randomized to the treatment group.
Participant milestones
| Measure |
Placebo-Run in Participants
All participants entered placebo-run in period for 14 days prior to randomization. During the period, exposures to the CAE were conducted to ascertain eligibility to enter the study. Those who qualified were randomized to either 0.25% HL036 Ophthalmic Solution group or placebo group.
|
0.25% HL036 Ophthalmic Solution
Participants self-administered HL036 0.25 % ophthalmic solution as topical ophthalmic drops, twice daily (BID) for up to 8 weeks. Exposures to the controlled adverse environment (CAE®) were conducted at Day 1, Day 15, Day 29 and Day 57.
|
Placebo
Participants self-administered HL036 placebo (vehicle solution) as topical ophthalmic drops, BID for up to 8 weeks. Exposures to the CAE® were conducted at Day 1, Day 15, Day 29 and Day 57.
|
|---|---|---|---|
|
Placebo Run-in (14 Days)
STARTED
|
1108
|
0
|
0
|
|
Placebo Run-in (14 Days)
COMPLETED
|
637
|
0
|
0
|
|
Placebo Run-in (14 Days)
NOT COMPLETED
|
471
|
0
|
0
|
|
Randomized Treatment Period (Days 57±3)
STARTED
|
0
|
318
|
319
|
|
Randomized Treatment Period (Days 57±3)
COMPLETED
|
0
|
291
|
294
|
|
Randomized Treatment Period (Days 57±3)
NOT COMPLETED
|
0
|
27
|
25
|
Reasons for withdrawal
| Measure |
Placebo-Run in Participants
All participants entered placebo-run in period for 14 days prior to randomization. During the period, exposures to the CAE were conducted to ascertain eligibility to enter the study. Those who qualified were randomized to either 0.25% HL036 Ophthalmic Solution group or placebo group.
|
0.25% HL036 Ophthalmic Solution
Participants self-administered HL036 0.25 % ophthalmic solution as topical ophthalmic drops, twice daily (BID) for up to 8 weeks. Exposures to the controlled adverse environment (CAE®) were conducted at Day 1, Day 15, Day 29 and Day 57.
|
Placebo
Participants self-administered HL036 placebo (vehicle solution) as topical ophthalmic drops, BID for up to 8 weeks. Exposures to the CAE® were conducted at Day 1, Day 15, Day 29 and Day 57.
|
|---|---|---|---|
|
Placebo Run-in (14 Days)
Eligibility Criteria Not Met
|
465
|
0
|
0
|
|
Placebo Run-in (14 Days)
Withdrawal by Subject
|
3
|
0
|
0
|
|
Placebo Run-in (14 Days)
Physician Decision
|
1
|
0
|
0
|
|
Placebo Run-in (14 Days)
Other
|
2
|
0
|
0
|
|
Randomized Treatment Period (Days 57±3)
Adverse Event
|
0
|
16
|
8
|
|
Randomized Treatment Period (Days 57±3)
Protocol Violation
|
0
|
6
|
5
|
|
Randomized Treatment Period (Days 57±3)
Administrative Reasons
|
0
|
2
|
4
|
|
Randomized Treatment Period (Days 57±3)
Withdrawal by Subject
|
0
|
2
|
4
|
|
Randomized Treatment Period (Days 57±3)
Other
|
0
|
1
|
4
|
Baseline Characteristics
A Study to Assess Efficacy and Safety of HL036 in Subjects With Dry Eyes
Baseline characteristics by cohort
| Measure |
0.25% HL036 Ophthalmic Solution
n=318 Participants
Participants self-administered HL036 0.25 percent (%) ophthalmic solution as topical ophthalmic drops, twice daily (BID) for up to 8 weeks. Exposures to the controlled adverse environment® (CAE) were conducted at Day 1, Day 15, Day 29 and Day 57.
|
Placebo
n=319 Participants
Participants sefl-administered HL036 placebo matching vehicle solution as topical ophthalmic drops, BID for up to 8 weeks. Exposures to the controlled adverse environment® (CAE) were conducted at Day 1, Day 15, Day 29 and Day 57.
|
Total
n=637 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
61.0 years
STANDARD_DEVIATION 12.86 • n=5 Participants
|
62.9 years
STANDARD_DEVIATION 14.02 • n=7 Participants
|
62.0 years
STANDARD_DEVIATION 13.48 • n=5 Participants
|
|
Sex: Female, Male
Female
|
230 Participants
n=5 Participants
|
211 Participants
n=7 Participants
|
441 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
88 Participants
n=5 Participants
|
108 Participants
n=7 Participants
|
196 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
24 Participants
n=5 Participants
|
25 Participants
n=7 Participants
|
49 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
294 Participants
n=5 Participants
|
294 Participants
n=7 Participants
|
588 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
18 Participants
n=5 Participants
|
19 Participants
n=7 Participants
|
37 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
71 Participants
n=5 Participants
|
53 Participants
n=7 Participants
|
124 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
228 Participants
n=5 Participants
|
238 Participants
n=7 Participants
|
466 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
1 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
8 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Pre-CAE and Post-CAE on Day 1 (Baseline) and Day 57Population: ITT Population with the Markov Chain Monte Carlo (MCMC) imputation method for missing values.
It was evaluated for the inferior region on the Ora Calibra® and Conjunctival staining scale. The score ranges from 0 to 4 (0=none and 4=severe), and lower score indicates improvement. Change score from pre- to post-CAE® was calculated as post-CAE® score - pre-CAE® score.
Outcome measures
| Measure |
Placebo
n=319 Participants
Participants self-administered HL036 placebo (vehicle solution) as topical ophthalmic drops, BID for up to 8 weeks. Exposures to the CAE® were conducted at Day 1, Day 15, Day 29 and Day 57.
|
0.25% HL036 Ophthalmic Solution
n=318 Participants
Participants self-administered HL036 0.25 % ophthalmic solution as topical ophthalmic drops BID for up to 8 weeks. Exposures to the CAE® were conducted at Day 1, Day 15, Day 29 and Day 57.
|
|---|---|---|
|
Coprimary Endpoint: Change From Baseline in Inferior Corneal Fluorescein Staining Score to Day 57 (Pre- to Post-CAE)
Day 1 (Change from Pre-CAE to Post-CAE)
|
1.31 score on a scale
Standard Deviation 0.411
|
1.38 score on a scale
Standard Deviation 0.427
|
|
Coprimary Endpoint: Change From Baseline in Inferior Corneal Fluorescein Staining Score to Day 57 (Pre- to Post-CAE)
Change from baseline: Day 57 (Change from Pre-CAE to Post-CAE)
|
-0.52 score on a scale
Standard Deviation 0.762
|
-0.47 score on a scale
Standard Deviation 0.900
|
PRIMARY outcome
Timeframe: Baseline (Day 1 Pre-CAE), Day 57 (Pre-CAE)Population: ITT Population with the MCMC imputation method for missing values.
It is assessed by the Ora Calibra® Ocular Discomfort scale. The score ranged from 0 to 4 (0=none and 4=severe) with 1 point increments, where lower scores indicate improvement.
Outcome measures
| Measure |
Placebo
n=319 Participants
Participants self-administered HL036 placebo (vehicle solution) as topical ophthalmic drops, BID for up to 8 weeks. Exposures to the CAE® were conducted at Day 1, Day 15, Day 29 and Day 57.
|
0.25% HL036 Ophthalmic Solution
n=318 Participants
Participants self-administered HL036 0.25 % ophthalmic solution as topical ophthalmic drops BID for up to 8 weeks. Exposures to the CAE® were conducted at Day 1, Day 15, Day 29 and Day 57.
|
|---|---|---|
|
Coprimary Endpoint: Change From Baseline in Ocular Discomfort Score to Day 57 (Pre-CAE)
Day 1 Pre-CAE
|
2.53 score on a scale
Standard Deviation 1.060
|
2.61 score on a scale
Standard Deviation 0.975
|
|
Coprimary Endpoint: Change From Baseline in Ocular Discomfort Score to Day 57 (Pre-CAE)
Change from Baseline: Day 57 (Pre-CAE)
|
-0.47 score on a scale
Standard Deviation 1.287
|
-0.47 score on a scale
Standard Deviation 1.318
|
SECONDARY outcome
Timeframe: Baseline (Day 1 Pre-CAE and Post-CAE), Day 8, Day 15 (Pre-CAE and Post-CAE), Day 29 (Pre-CAE and Post-CAE), and Day 57 (Pre-CAE and Post-CAE)Population: Number of participants analyzed included participants in ITT Population with available data. The analysis was carried out with observed data only.
It is evaluated for the inferior region on the Ora Calibra® and Conjunctival staining scale. The score ranges from 0 to 4 (0=none and 4=severe), and lower score indicates improvement. Change score from pre- to post-CAE® was calculated as post-CAE® score - pre-CAE® score.
Outcome measures
| Measure |
Placebo
n=319 Participants
Participants self-administered HL036 placebo (vehicle solution) as topical ophthalmic drops, BID for up to 8 weeks. Exposures to the CAE® were conducted at Day 1, Day 15, Day 29 and Day 57.
|
0.25% HL036 Ophthalmic Solution
n=318 Participants
Participants self-administered HL036 0.25 % ophthalmic solution as topical ophthalmic drops BID for up to 8 weeks. Exposures to the CAE® were conducted at Day 1, Day 15, Day 29 and Day 57.
|
|---|---|---|
|
Mean Change From Baseline in Fluorescein Staining (Inferior Region)
Change from baseline: Day 57 (Change from Pre-CAE to Post-CAE)
|
-0.53 score on a scale
Standard Deviation 0.709
|
-0.47 score on a scale
Standard Deviation 0.829
|
|
Mean Change From Baseline in Fluorescein Staining (Inferior Region)
Day 1 Pre-CAE
|
1.84 score on a scale
Standard Deviation 0.527
|
1.78 score on a scale
Standard Deviation 0.550
|
|
Mean Change From Baseline in Fluorescein Staining (Inferior Region)
Day 1 Post-CAE
|
3.15 score on a scale
Standard Deviation 0.546
|
3.17 score on a scale
Standard Deviation 0.548
|
|
Mean Change From Baseline in Fluorescein Staining (Inferior Region)
Day 1 (Change from Pre-CAE to Post-CAE)
|
1.31 score on a scale
Standard Deviation 0.411
|
1.38 score on a scale
Standard Deviation 0.427
|
|
Mean Change From Baseline in Fluorescein Staining (Inferior Region)
Change from Baseline: Day 8
|
-0.02 score on a scale
Standard Deviation 0.637
|
0.08 score on a scale
Standard Deviation 0.626
|
|
Mean Change From Baseline in Fluorescein Staining (Inferior Region)
Change from Baseline: Day 15 (Pre-CAE)
|
-0.14 score on a scale
Standard Deviation 0.648
|
-0.08 score on a scale
Standard Deviation 0.730
|
|
Mean Change From Baseline in Fluorescein Staining (Inferior Region)
Change from Baseline: Day 15 (Post-CAE)
|
-0.58 score on a scale
Standard Deviation 0.703
|
-0.54 score on a scale
Standard Deviation 0.797
|
|
Mean Change From Baseline in Fluorescein Staining (Inferior Region)
Change from baseline: Day 15 (Change from Pre-CAE to Post-CAE)
|
-0.44 score on a scale
Standard Deviation 0.746
|
-0.46 score on a scale
Standard Deviation 0.843
|
|
Mean Change From Baseline in Fluorescein Staining (Inferior Region)
Change from Baseline: Day 29 (Pre-CAE)
|
-0.19 score on a scale
Standard Deviation 0.741
|
-0.14 score on a scale
Standard Deviation 0.651
|
|
Mean Change From Baseline in Fluorescein Staining (Inferior Region)
Change from Baseline: Day 29 (Post-CAE)
|
-0.69 score on a scale
Standard Deviation 0.771
|
-0.60 score on a scale
Standard Deviation 0.851
|
|
Mean Change From Baseline in Fluorescein Staining (Inferior Region)
Change from baseline: Day 29 (Change from Pre-CAE to Post-CAE)
|
-0.49 score on a scale
Standard Deviation 0.795
|
-0.48 score on a scale
Standard Deviation 0.840
|
|
Mean Change From Baseline in Fluorescein Staining (Inferior Region)
Change from Baseline: Day 57 (Pre-CAE)
|
-0.12 score on a scale
Standard Deviation 0.713
|
-0.13 score on a scale
Standard Deviation 0.734
|
|
Mean Change From Baseline in Fluorescein Staining (Inferior Region)
Change from Baseline: Day 57 (Post-CAE)
|
-0.65 score on a scale
Standard Deviation 0.734
|
-0.60 score on a scale
Standard Deviation 0.855
|
SECONDARY outcome
Timeframe: Baseline (Day 1 Pre-CAE and Post-CAE), Day 8, Day 15 (Pre-CAE and Post-CAE), Day 29 (Pre-CAE and Post-CAE), and Day 57 (Pre-CAE and Post-CAE)Population: Number of participants analyzed included participants in ITT Population with available data. The analysis was carried out with observed data only.
It is evaluated for the superior region on the Ora Calibra® and Conjunctival staining scale. The score ranges from 0 to 4 (0=none and 4=severe), and lower score indicates improvement. Change score from pre- to post-CAE® was calculated as post-CAE® score - pre-CAE® score.
Outcome measures
| Measure |
Placebo
n=319 Participants
Participants self-administered HL036 placebo (vehicle solution) as topical ophthalmic drops, BID for up to 8 weeks. Exposures to the CAE® were conducted at Day 1, Day 15, Day 29 and Day 57.
|
0.25% HL036 Ophthalmic Solution
n=318 Participants
Participants self-administered HL036 0.25 % ophthalmic solution as topical ophthalmic drops BID for up to 8 weeks. Exposures to the CAE® were conducted at Day 1, Day 15, Day 29 and Day 57.
|
|---|---|---|
|
Mean Change From Baseline in Fluorescein Staining (Superior Region)
Day 1 Pre-CAE
|
1.82 score on a scale
Standard Deviation 0.556
|
1.81 score on a scale
Standard Deviation 0.617
|
|
Mean Change From Baseline in Fluorescein Staining (Superior Region)
Day 1 Post-CAE
|
2.20 score on a scale
Standard Deviation 0.638
|
2.19 score on a scale
Standard Deviation 0.614
|
|
Mean Change From Baseline in Fluorescein Staining (Superior Region)
Day 1 (Change from Pre-CAE to Post-CAE)
|
0.39 score on a scale
Standard Deviation 0.625
|
0.39 score on a scale
Standard Deviation 0.629
|
|
Mean Change From Baseline in Fluorescein Staining (Superior Region)
Change from Baseline: Day 8
|
-0.15 score on a scale
Standard Deviation 0.639
|
-0.10 score on a scale
Standard Deviation 0.665
|
|
Mean Change From Baseline in Fluorescein Staining (Superior Region)
Change from Baseline: Day 15 (Pre-CAE)
|
-0.26 score on a scale
Standard Deviation 0.616
|
-0.24 score on a scale
Standard Deviation 0.665
|
|
Mean Change From Baseline in Fluorescein Staining (Superior Region)
Change from Baseline: Day 15 (Post-CAE)
|
-0.35 score on a scale
Standard Deviation 0.735
|
-0.31 score on a scale
Standard Deviation 0.732
|
|
Mean Change From Baseline in Fluorescein Staining (Superior Region)
Change from baseline: Day 15 (Change from Pre-CAE to Post-CAE)
|
-0.09 score on a scale
Standard Deviation 0.836
|
-0.08 score on a scale
Standard Deviation 0.800
|
|
Mean Change From Baseline in Fluorescein Staining (Superior Region)
Change from Baseline: Day 29 (Pre-CAE)
|
-0.36 score on a scale
Standard Deviation 0.677
|
-0.35 score on a scale
Standard Deviation 0.652
|
|
Mean Change From Baseline in Fluorescein Staining (Superior Region)
Change from Baseline: Day 29 (Post-CAE)
|
-0.41 score on a scale
Standard Deviation 0.681
|
-0.44 score on a scale
Standard Deviation 0.774
|
|
Mean Change From Baseline in Fluorescein Staining (Superior Region)
Change from baseline: Day 29 (Change from Pre-CAE to Post-CAE)
|
-0.05 score on a scale
Standard Deviation 0.738
|
-0.09 score on a scale
Standard Deviation 0.887
|
|
Mean Change From Baseline in Fluorescein Staining (Superior Region)
Change from Baseline: Day 57 (Pre-CAE)
|
-0.26 score on a scale
Standard Deviation 0.672
|
-0.36 score on a scale
Standard Deviation 0.677
|
|
Mean Change From Baseline in Fluorescein Staining (Superior Region)
Change from Baseline: Day 57 (Post-CAE)
|
-0.37 score on a scale
Standard Deviation 0.710
|
-0.35 score on a scale
Standard Deviation 0.779
|
|
Mean Change From Baseline in Fluorescein Staining (Superior Region)
Change from baseline: Day 57 (Change from Pre-CAE to Post-CAE)
|
-0.11 score on a scale
Standard Deviation 0.902
|
0.01 score on a scale
Standard Deviation 0.880
|
SECONDARY outcome
Timeframe: Baseline (Day 1 Pre-CAE and Post-CAE), Day 8, Day 15 (Pre-CAE and Post-CAE), Day 29 (Pre-CAE and Post-CAE), and Day 57 (Pre-CAE and Post-CAE)Population: Number of participants analyzed included participants in ITT Population with available data. The analysis was carried out with observed data only.
It is evaluated for the central region on the Ora Calibra® and Conjunctival staining scale. The score ranges from 0 to 4 (0=none and 4=severe), and lower score indicates improvement. Change score from pre- to post-CAE® was calculated as post-CAE® score - pre-CAE® score.
Outcome measures
| Measure |
Placebo
n=319 Participants
Participants self-administered HL036 placebo (vehicle solution) as topical ophthalmic drops, BID for up to 8 weeks. Exposures to the CAE® were conducted at Day 1, Day 15, Day 29 and Day 57.
|
0.25% HL036 Ophthalmic Solution
n=318 Participants
Participants self-administered HL036 0.25 % ophthalmic solution as topical ophthalmic drops BID for up to 8 weeks. Exposures to the CAE® were conducted at Day 1, Day 15, Day 29 and Day 57.
|
|---|---|---|
|
Mean Change From Baseline in Fluorescein Staining (Central Region)
Day 1 Pre-CAE
|
1.36 score on a scale
Standard Deviation 0.654
|
1.40 score on a scale
Standard Deviation 0.780
|
|
Mean Change From Baseline in Fluorescein Staining (Central Region)
Day 1 Post-CAE
|
1.66 score on a scale
Standard Deviation 0.721
|
1.63 score on a scale
Standard Deviation 0.779
|
|
Mean Change From Baseline in Fluorescein Staining (Central Region)
Day 1 (Change from Pre-CAE to Post-CAE)
|
0.30 score on a scale
Standard Deviation 0.552
|
0.22 score on a scale
Standard Deviation 0.674
|
|
Mean Change From Baseline in Fluorescein Staining (Central Region)
Change from Baseline: Day 8
|
-0.02 score on a scale
Standard Deviation 0.746
|
-0.14 score on a scale
Standard Deviation 0.726
|
|
Mean Change From Baseline in Fluorescein Staining (Central Region)
Change from Baseline: Day 15 (Pre-CAE)
|
-0.17 score on a scale
Standard Deviation 0.694
|
-0.24 score on a scale
Standard Deviation 0.748
|
|
Mean Change From Baseline in Fluorescein Staining (Central Region)
Change from Baseline: Day 15 (Post-CAE)
|
-0.24 score on a scale
Standard Deviation 0.742
|
-0.23 score on a scale
Standard Deviation 0.770
|
|
Mean Change From Baseline in Fluorescein Staining (Central Region)
Change from baseline: Day 15 (Change from Pre-CAE to Post-CAE)
|
-0.08 score on a scale
Standard Deviation 0.757
|
0.00 score on a scale
Standard Deviation 0.818
|
|
Mean Change From Baseline in Fluorescein Staining (Central Region)
Change from Baseline: Day 29 (Pre-CAE)
|
-0.23 score on a scale
Standard Deviation 0.737
|
-0.38 score on a scale
Standard Deviation 0.785
|
|
Mean Change From Baseline in Fluorescein Staining (Central Region)
Change from Baseline: Day 29 (Post-CAE)
|
-0.38 score on a scale
Standard Deviation 0.643
|
-0.38 score on a scale
Standard Deviation 0.718
|
|
Mean Change From Baseline in Fluorescein Staining (Central Region)
Change from baseline: Day 29 (Change from Pre-CAE to Post-CAE)
|
-0.14 score on a scale
Standard Deviation 0.753
|
-0.01 score on a scale
Standard Deviation 0.892
|
|
Mean Change From Baseline in Fluorescein Staining (Central Region)
Change from Baseline: Day 57 (Pre-CAE)
|
-0.18 score on a scale
Standard Deviation 0.758
|
-0.32 score on a scale
Standard Deviation 0.834
|
|
Mean Change From Baseline in Fluorescein Staining (Central Region)
Change from Baseline: Day 57 (Post-CAE)
|
-0.29 score on a scale
Standard Deviation 0.687
|
-0.25 score on a scale
Standard Deviation 0.770
|
|
Mean Change From Baseline in Fluorescein Staining (Central Region)
Change from baseline: Day 57 (Change from Pre-CAE to Post-CAE)
|
-0.10 score on a scale
Standard Deviation 0.867
|
0.07 score on a scale
Standard Deviation 0.944
|
SECONDARY outcome
Timeframe: Baseline (Day 1 Pre-CAE and Post-CAE), Day 8, Day 15 (Pre-CAE and Post-CAE), Day 29 (Pre-CAE and Post-CAE), and Day 57 (Pre-CAE and Post-CAE)Population: Number of participants analyzed included participants in ITT Population with available data. The analysis was carried out with observed data only.
It is evaluated for the temporal region on the Ora Calibra® and Conjunctival staining scale. The score ranges from 0 to 4 (0=none and 4=severe), and lower score indicates improvement. Change score from pre- to post-CAE® was calculated as post-CAE® score - pre-CAE® score.
Outcome measures
| Measure |
Placebo
n=319 Participants
Participants self-administered HL036 placebo (vehicle solution) as topical ophthalmic drops, BID for up to 8 weeks. Exposures to the CAE® were conducted at Day 1, Day 15, Day 29 and Day 57.
|
0.25% HL036 Ophthalmic Solution
n=318 Participants
Participants self-administered HL036 0.25 % ophthalmic solution as topical ophthalmic drops BID for up to 8 weeks. Exposures to the CAE® were conducted at Day 1, Day 15, Day 29 and Day 57.
|
|---|---|---|
|
Mean Change From Baseline in Fluorescein Staining (Temporal Region)
Day 1 Pre-CAE
|
1.67 score on a scale
Standard Deviation 0.738
|
1.62 score on a scale
Standard Deviation 0.701
|
|
Mean Change From Baseline in Fluorescein Staining (Temporal Region)
Day 1 Post-CAE
|
1.95 score on a scale
Standard Deviation 0.704
|
1.94 score on a scale
Standard Deviation 0.692
|
|
Mean Change From Baseline in Fluorescein Staining (Temporal Region)
Day 1 (Change from Pre-CAE to Post-CAE)
|
0.28 score on a scale
Standard Deviation 0.600
|
0.33 score on a scale
Standard Deviation 0.636
|
|
Mean Change From Baseline in Fluorescein Staining (Temporal Region)
Change from Baseline: Day 8
|
-0.07 score on a scale
Standard Deviation 0.683
|
-0.06 score on a scale
Standard Deviation 0.714
|
|
Mean Change From Baseline in Fluorescein Staining (Temporal Region)
Change from Baseline: Day 15 (Pre-CAE)
|
-0.20 score on a scale
Standard Deviation 0.726
|
-0.18 score on a scale
Standard Deviation 0.760
|
|
Mean Change From Baseline in Fluorescein Staining (Temporal Region)
Change from Baseline: Day 15 (Post-CAE)
|
-0.24 score on a scale
Standard Deviation 0.715
|
-0.25 score on a scale
Standard Deviation 0.705
|
|
Mean Change From Baseline in Fluorescein Staining (Temporal Region)
Change from baseline: Day 15 (Change from Pre-CAE to Post-CAE)
|
-0.05 score on a scale
Standard Deviation 0.801
|
-0.06 score on a scale
Standard Deviation 0.840
|
|
Mean Change From Baseline in Fluorescein Staining (Temporal Region)
Change from Baseline: Day 29 (Pre-CAE)
|
-0.11 score on a scale
Standard Deviation 0.756
|
-0.12 score on a scale
Standard Deviation 0.700
|
|
Mean Change From Baseline in Fluorescein Staining (Temporal Region)
Change from Baseline: Day 29 (Post-CAE)
|
-0.17 score on a scale
Standard Deviation 0.691
|
-0.22 score on a scale
Standard Deviation 0.691
|
|
Mean Change From Baseline in Fluorescein Staining (Temporal Region)
Change from baseline: Day 29 (Change from Pre-CAE to Post-CAE)
|
-0.07 score on a scale
Standard Deviation 0.818
|
-0.10 score on a scale
Standard Deviation 0.852
|
|
Mean Change From Baseline in Fluorescein Staining (Temporal Region)
Change from Baseline: Day 57 (Pre-CAE)
|
-0.11 score on a scale
Standard Deviation 0.715
|
-0.10 score on a scale
Standard Deviation 0.775
|
|
Mean Change From Baseline in Fluorescein Staining (Temporal Region)
Change from Baseline: Day 57 (Post-CAE)
|
-0.18 score on a scale
Standard Deviation 0.698
|
-0.11 score on a scale
Standard Deviation 0.730
|
|
Mean Change From Baseline in Fluorescein Staining (Temporal Region)
Change from baseline: Day 57 (Change from Pre-CAE to Post-CAE)
|
-0.07 score on a scale
Standard Deviation 0.838
|
-0.01 score on a scale
Standard Deviation 0.907
|
SECONDARY outcome
Timeframe: Baseline (Day 1 Pre-CAE and Post-CAE), Day 8, Day 15 (Pre-CAE and Post-CAE), Day 29 (Pre-CAE and Post-CAE), and Day 57 (Pre-CAE and Post-CAE)Population: Number of participants analyzed included participants in ITT Population with available data. The analysis was carried out with observed data only.
It is evaluated for the nasal region on the Ora Calibra® and Conjunctival staining scale. The score ranges from 0 to 4 (0=none and 4=severe), and lower score indicates improvement. Change score from pre- to post-CAE® was calculated as post-CAE® score - pre-CAE® score.
Outcome measures
| Measure |
Placebo
n=319 Participants
Participants self-administered HL036 placebo (vehicle solution) as topical ophthalmic drops, BID for up to 8 weeks. Exposures to the CAE® were conducted at Day 1, Day 15, Day 29 and Day 57.
|
0.25% HL036 Ophthalmic Solution
n=318 Participants
Participants self-administered HL036 0.25 % ophthalmic solution as topical ophthalmic drops BID for up to 8 weeks. Exposures to the CAE® were conducted at Day 1, Day 15, Day 29 and Day 57.
|
|---|---|---|
|
Mean Change From Baseline in Fluorescein Staining (Nasal Region)
Day 1 Pre-CAE
|
1.73 score on a scale
Standard Deviation 0.756
|
1.71 score on a scale
Standard Deviation 0.740
|
|
Mean Change From Baseline in Fluorescein Staining (Nasal Region)
Day 1 Post-CAE
|
2.08 score on a scale
Standard Deviation 0.813
|
2.10 score on a scale
Standard Deviation 0.760
|
|
Mean Change From Baseline in Fluorescein Staining (Nasal Region)
Day 1 (Change from Pre-CAE to Post-CAE)
|
0.35 score on a scale
Standard Deviation 0.663
|
0.39 score on a scale
Standard Deviation 0.666
|
|
Mean Change From Baseline in Fluorescein Staining (Nasal Region)
Change from Baseline: Day 8
|
-0.03 score on a scale
Standard Deviation 0.673
|
-0.04 score on a scale
Standard Deviation 0.665
|
|
Mean Change From Baseline in Fluorescein Staining (Nasal Region)
Change from Baseline: Day 15 (Pre-CAE)
|
-0.14 score on a scale
Standard Deviation 0.690
|
-0.13 score on a scale
Standard Deviation 0.748
|
|
Mean Change From Baseline in Fluorescein Staining (Nasal Region)
Change from Baseline: Day 15 (Post-CAE)
|
-0.18 score on a scale
Standard Deviation 0.797
|
-0.20 score on a scale
Standard Deviation 0.820
|
|
Mean Change From Baseline in Fluorescein Staining (Nasal Region)
Change from baseline: Day 15 (Change from Pre-CAE to Post-CAE)
|
-0.04 score on a scale
Standard Deviation 0.883
|
-0.07 score on a scale
Standard Deviation 0.861
|
|
Mean Change From Baseline in Fluorescein Staining (Nasal Region)
Change from Baseline: Day 29 (Pre-CAE)
|
-0.14 score on a scale
Standard Deviation 0.733
|
-0.11 score on a scale
Standard Deviation 0.714
|
|
Mean Change From Baseline in Fluorescein Staining (Nasal Region)
Change from Baseline: Day 29 (Post-CAE)
|
-0.17 score on a scale
Standard Deviation 0.787
|
-0.23 score on a scale
Standard Deviation 0.779
|
|
Mean Change From Baseline in Fluorescein Staining (Nasal Region)
Change from baseline: Day 29 (Change from Pre-CAE to Post-CAE)
|
-0.03 score on a scale
Standard Deviation 0.837
|
-0.12 score on a scale
Standard Deviation 0.896
|
|
Mean Change From Baseline in Fluorescein Staining (Nasal Region)
Change from Baseline: Day 57 (Pre-CAE)
|
-0.08 score on a scale
Standard Deviation 0.706
|
-0.11 score on a scale
Standard Deviation 0.743
|
|
Mean Change From Baseline in Fluorescein Staining (Nasal Region)
Change from Baseline: Day 57 (Post-CAE)
|
-0.15 score on a scale
Standard Deviation 0.760
|
-0.16 score on a scale
Standard Deviation 0.837
|
|
Mean Change From Baseline in Fluorescein Staining (Nasal Region)
Change from baseline: Day 57 (Change from Pre-CAE to Post-CAE)
|
-0.06 score on a scale
Standard Deviation 0.886
|
-0.06 score on a scale
Standard Deviation 0.891
|
SECONDARY outcome
Timeframe: Baseline (Day 1 Pre-CAE and Post-CAE), Day 8, Day 15 (Pre-CAE and Post-CAE), Day 29 (Pre-CAE and Post-CAE), and Day 57 (Pre-CAE and Post-CAE)Population: Number of participants analyzed included participants in ITT Population with available data. The analysis was carried out with observed data only.
Corneal sum score is the sum of all regions of the cornea (inferior, superior and central regions). Individual region score was evaluated on the Ora Calibra® and Conjunctival staining scale. Individual region score ranges from 0 to 4 (0=none and 4=severe), and lower score indicates improvement. Corneal sum score ranges from 0 to 12. Change score from pre- to post-CAE® was calculated as post-CAE® score - pre-CAE® score.
Outcome measures
| Measure |
Placebo
n=319 Participants
Participants self-administered HL036 placebo (vehicle solution) as topical ophthalmic drops, BID for up to 8 weeks. Exposures to the CAE® were conducted at Day 1, Day 15, Day 29 and Day 57.
|
0.25% HL036 Ophthalmic Solution
n=318 Participants
Participants self-administered HL036 0.25 % ophthalmic solution as topical ophthalmic drops BID for up to 8 weeks. Exposures to the CAE® were conducted at Day 1, Day 15, Day 29 and Day 57.
|
|---|---|---|
|
Mean Change From Baseline in Fluorescein Staining (Corneal Sum)
Day 1 Pre-CAE
|
5.01 score on a scale
Standard Deviation 1.123
|
4.99 score on a scale
Standard Deviation 1.266
|
|
Mean Change From Baseline in Fluorescein Staining (Corneal Sum)
Day 1 Post-CAE
|
7.01 score on a scale
Standard Deviation 1.359
|
6.99 score on a scale
Standard Deviation 1.369
|
|
Mean Change From Baseline in Fluorescein Staining (Corneal Sum)
Day 1 (Change from Pre-CAE to Post-CAE)
|
2.00 score on a scale
Standard Deviation 1.065
|
1.99 score on a scale
Standard Deviation 1.103
|
|
Mean Change From Baseline in Fluorescein Staining (Corneal Sum)
Change from Baseline: Day 8
|
-0.18 score on a scale
Standard Deviation 1.475
|
-0.16 score on a scale
Standard Deviation 1.406
|
|
Mean Change From Baseline in Fluorescein Staining (Corneal Sum)
Change from Baseline: Day 15 (Pre-CAE)
|
-0.57 score on a scale
Standard Deviation 1.436
|
-0.56 score on a scale
Standard Deviation 1.505
|
|
Mean Change From Baseline in Fluorescein Staining (Corneal Sum)
Change from Baseline: Day 15 (Post-CAE)
|
-1.17 score on a scale
Standard Deviation 1.576
|
-1.08 score on a scale
Standard Deviation 1.673
|
|
Mean Change From Baseline in Fluorescein Staining (Corneal Sum)
Change from baseline: Day 15 (Change from Pre-CAE to Post-CAE)
|
-0.62 score on a scale
Standard Deviation 1.562
|
-0.53 score on a scale
Standard Deviation 1.646
|
|
Mean Change From Baseline in Fluorescein Staining (Corneal Sum)
Change from Baseline: Day 29 (Pre-CAE)
|
-0.78 score on a scale
Standard Deviation 1.630
|
-0.87 score on a scale
Standard Deviation 1.475
|
|
Mean Change From Baseline in Fluorescein Staining (Corneal Sum)
Change from Baseline: Day 29 (Post-CAE)
|
-1.47 score on a scale
Standard Deviation 1.519
|
-1.42 score on a scale
Standard Deviation 1.698
|
|
Mean Change From Baseline in Fluorescein Staining (Corneal Sum)
Change from baseline: Day 29 (Change from Pre-CAE to Post-CAE)
|
-0.68 score on a scale
Standard Deviation 1.644
|
-0.57 score on a scale
Standard Deviation 1.737
|
|
Mean Change From Baseline in Fluorescein Staining (Corneal Sum)
Change from Baseline: Day 57 (Pre-CAE)
|
-0.56 score on a scale
Standard Deviation 1.645
|
-0.82 score on a scale
Standard Deviation 1.664
|
|
Mean Change From Baseline in Fluorescein Staining (Corneal Sum)
Change from Baseline: Day 57 (Post-CAE)
|
-1.31 score on a scale
Standard Deviation 1.603
|
-1.20 score on a scale
Standard Deviation 1.840
|
|
Mean Change From Baseline in Fluorescein Staining (Corneal Sum)
Change from baseline: Day 57 (Change from Pre-CAE to Post-CAE)
|
-0.74 score on a scale
Standard Deviation 1.811
|
-0.39 score on a scale
Standard Deviation 1.853
|
SECONDARY outcome
Timeframe: Baseline (Day 1 Pre-CAE and Post-CAE), Day 8, Day 15 (Pre-CAE and Post-CAE), Day 29 (Pre-CAE and Post-CAE), and Day 57 (Pre-CAE and Post-CAE)Population: Number of participants analyzed included participants in ITT Population with available data. The analysis was carried out with observed data only.
Conjunctival sum score is the sum of all regions of the conjunctiva (temporal and nasal regions). Individual region score was evaluated on the Ora Calibra® and Conjunctival staining scale. Individual region score ranges from 0 to 4 (0=none and 4=severe), and lower score indicates improvement. Corneal sum score ranges from 0 to 8. Change score from pre- to post-CAE® was calculated as post-CAE® score - pre-CAE® score.
Outcome measures
| Measure |
Placebo
n=319 Participants
Participants self-administered HL036 placebo (vehicle solution) as topical ophthalmic drops, BID for up to 8 weeks. Exposures to the CAE® were conducted at Day 1, Day 15, Day 29 and Day 57.
|
0.25% HL036 Ophthalmic Solution
n=318 Participants
Participants self-administered HL036 0.25 % ophthalmic solution as topical ophthalmic drops BID for up to 8 weeks. Exposures to the CAE® were conducted at Day 1, Day 15, Day 29 and Day 57.
|
|---|---|---|
|
Mean Change From Baseline in Fluorescein Staining (Conjunctival Sum)
Day 1 Pre-CAE
|
3.40 score on a scale
Standard Deviation 1.363
|
3.33 score on a scale
Standard Deviation 1.327
|
|
Mean Change From Baseline in Fluorescein Staining (Conjunctival Sum)
Day 1 Post-CAE
|
4.03 score on a scale
Standard Deviation 1.366
|
4.05 score on a scale
Standard Deviation 1.305
|
|
Mean Change From Baseline in Fluorescein Staining (Conjunctival Sum)
Day 1 (Change from Pre-CAE to Post-CAE)
|
0.63 score on a scale
Standard Deviation 1.046
|
0.71 score on a scale
Standard Deviation 1.084
|
|
Mean Change From Baseline in Fluorescein Staining (Conjunctival Sum)
Change from Baseline: Day 8
|
-0.10 score on a scale
Standard Deviation 1.129
|
-0.10 score on a scale
Standard Deviation 1.187
|
|
Mean Change From Baseline in Fluorescein Staining (Conjunctival Sum)
Change from Baseline: Day 15 (Pre-CAE)
|
-0.34 score on a scale
Standard Deviation 1.218
|
-0.31 score on a scale
Standard Deviation 1.336
|
|
Mean Change From Baseline in Fluorescein Staining (Conjunctival Sum)
Change from Baseline: Day 15 (Post-CAE)
|
-0.42 score on a scale
Standard Deviation 1.340
|
-0.44 score on a scale
Standard Deviation 1.308
|
|
Mean Change From Baseline in Fluorescein Staining (Conjunctival Sum)
Change from baseline: Day 15 (Change from Pre-CAE to Post-CAE)
|
-0.08 score on a scale
Standard Deviation 1.399
|
-0.13 score on a scale
Standard Deviation 1.388
|
|
Mean Change From Baseline in Fluorescein Staining (Conjunctival Sum)
Change from Baseline: Day 29 (Pre-CAE)
|
-0.25 score on a scale
Standard Deviation 1.308
|
-0.23 score on a scale
Standard Deviation 1.225
|
|
Mean Change From Baseline in Fluorescein Staining (Conjunctival Sum)
Change from Baseline: Day 29 (Post-CAE)
|
-0.34 score on a scale
Standard Deviation 1.215
|
-0.45 score on a scale
Standard Deviation 1.285
|
|
Mean Change From Baseline in Fluorescein Staining (Conjunctival Sum)
Change from baseline: Day 29 (Change from Pre-CAE to Post-CAE)
|
-0.10 score on a scale
Standard Deviation 1.357
|
-0.22 score on a scale
Standard Deviation 1.501
|
|
Mean Change From Baseline in Fluorescein Staining (Conjunctival Sum)
Change from Baseline: Day 57 (Pre-CAE)
|
-0.19 score on a scale
Standard Deviation 1.215
|
-0.22 score on a scale
Standard Deviation 1.332
|
|
Mean Change From Baseline in Fluorescein Staining (Conjunctival Sum)
Change from Baseline: Day 57 (Post-CAE)
|
-0.33 score on a scale
Standard Deviation 1.280
|
-0.27 score on a scale
Standard Deviation 1.345
|
|
Mean Change From Baseline in Fluorescein Staining (Conjunctival Sum)
Change from baseline: Day 57 (Change from Pre-CAE to Post-CAE)
|
-0.12 score on a scale
Standard Deviation 1.432
|
-0.07 score on a scale
Standard Deviation 1.479
|
SECONDARY outcome
Timeframe: Baseline (Day 1 Pre-CAE and Post-CAE), Day 8, Day 15 (Pre-CAE and Post-CAE), Day 29 (Pre-CAE and Post-CAE), and Day 57 (Pre-CAE and Post-CAE)Population: Number of participants analyzed included participants in ITT Population with available data. The analysis was carried out with observed data only.
Total score was sum of all 5 regions: central, superior, inferior, temporal, and nasal. Individual region score was evaluated on the Ora Calibra® and Conjunctival staining scale. Individual region score ranges from 0 to 4 (0=none and 4=severe), and lower score indicates improvement. Total score ranges from 0 to 20. Change score from pre- to post-CAE® was calculated as post-CAE® score - pre-CAE® score.
Outcome measures
| Measure |
Placebo
n=319 Participants
Participants self-administered HL036 placebo (vehicle solution) as topical ophthalmic drops, BID for up to 8 weeks. Exposures to the CAE® were conducted at Day 1, Day 15, Day 29 and Day 57.
|
0.25% HL036 Ophthalmic Solution
n=318 Participants
Participants self-administered HL036 0.25 % ophthalmic solution as topical ophthalmic drops BID for up to 8 weeks. Exposures to the CAE® were conducted at Day 1, Day 15, Day 29 and Day 57.
|
|---|---|---|
|
Mean Change From Baseline in Fluorescein Staining Total Score (All Five Regions: Central, Superior, Inferior, Temporal, Nasal)
Day 1 Pre-CAE
|
8.41 score on a scale
Standard Deviation 2.075
|
8.33 score on a scale
Standard Deviation 2.209
|
|
Mean Change From Baseline in Fluorescein Staining Total Score (All Five Regions: Central, Superior, Inferior, Temporal, Nasal)
Day 1 Post-CAE
|
11.04 score on a scale
Standard Deviation 2.246
|
11.03 score on a scale
Standard Deviation 2.164
|
|
Mean Change From Baseline in Fluorescein Staining Total Score (All Five Regions: Central, Superior, Inferior, Temporal, Nasal)
Day 1 (Change from Pre-CAE to Post-CAE)
|
2.63 score on a scale
Standard Deviation 1.703
|
2.71 score on a scale
Standard Deviation 1.668
|
|
Mean Change From Baseline in Fluorescein Staining Total Score (All Five Regions: Central, Superior, Inferior, Temporal, Nasal)
Change from Baseline: Day 8
|
-0.29 score on a scale
Standard Deviation 2.208
|
-0.26 score on a scale
Standard Deviation 2.191
|
|
Mean Change From Baseline in Fluorescein Staining Total Score (All Five Regions: Central, Superior, Inferior, Temporal, Nasal)
Change from Baseline: Day 15 (Pre-CAE)
|
-0.91 score on a scale
Standard Deviation 2.296
|
-0.87 score on a scale
Standard Deviation 2.462
|
|
Mean Change From Baseline in Fluorescein Staining Total Score (All Five Regions: Central, Superior, Inferior, Temporal, Nasal)
Change from Baseline: Day 15 (Post-CAE)
|
-1.59 score on a scale
Standard Deviation 2.440
|
-1.53 score on a scale
Standard Deviation 2.442
|
|
Mean Change From Baseline in Fluorescein Staining Total Score (All Five Regions: Central, Superior, Inferior, Temporal, Nasal)
Change from baseline: Day 15 (Change from Pre-CAE to Post-CAE)
|
-0.70 score on a scale
Standard Deviation 2.403
|
-0.66 score on a scale
Standard Deviation 2.393
|
|
Mean Change From Baseline in Fluorescein Staining Total Score (All Five Regions: Central, Superior, Inferior, Temporal, Nasal)
Change from Baseline: Day 29 (Pre-CAE)
|
-1.02 score on a scale
Standard Deviation 2.521
|
-1.10 score on a scale
Standard Deviation 2.298
|
|
Mean Change From Baseline in Fluorescein Staining Total Score (All Five Regions: Central, Superior, Inferior, Temporal, Nasal)
Change from Baseline: Day 29 (Post-CAE)
|
-1.82 score on a scale
Standard Deviation 2.288
|
-1.87 score on a scale
Standard Deviation 2.496
|
|
Mean Change From Baseline in Fluorescein Staining Total Score (All Five Regions: Central, Superior, Inferior, Temporal, Nasal)
Change from baseline: Day 29 (Change from Pre-CAE to Post-CAE)
|
-0.78 score on a scale
Standard Deviation 2.423
|
-0.79 score on a scale
Standard Deviation 2.618
|
|
Mean Change From Baseline in Fluorescein Staining Total Score (All Five Regions: Central, Superior, Inferior, Temporal, Nasal)
Change from Baseline: Day 57 (Pre-CAE)
|
-0.75 score on a scale
Standard Deviation 2.445
|
-1.03 score on a scale
Standard Deviation 2.522
|
|
Mean Change From Baseline in Fluorescein Staining Total Score (All Five Regions: Central, Superior, Inferior, Temporal, Nasal)
Change from Baseline: Day 57 (Post-CAE)
|
-1.64 score on a scale
Standard Deviation 2.423
|
-1.48 score on a scale
Standard Deviation 2.711
|
|
Mean Change From Baseline in Fluorescein Staining Total Score (All Five Regions: Central, Superior, Inferior, Temporal, Nasal)
Change from baseline: Day 57 (Change from Pre-CAE to Post-CAE)
|
-0.86 score on a scale
Standard Deviation 2.739
|
-0.46 score on a scale
Standard Deviation 2.693
|
SECONDARY outcome
Timeframe: Baseline (Day 1 Pre-CAE and Post-CAE), Day 8, Day 15 (Pre-CAE and Post-CAE), Day 29 (Pre-CAE and Post-CAE), and Day 57 (Pre-CAE and Post-CAE)Population: Number of participants analyzed included participants in ITT Population with available data. The analysis was carried out with observed data only.
It is evaluated for the inferior region on the lissamine green corneal and conjunctival staining scale (Ora Calibra® scale). The score ranges from 0 to 4 (0=none and 4=severe), and lower score indicates improvement. Change score from pre- to post-CAE® was calculated as post-CAE® score - pre-CAE® score.
Outcome measures
| Measure |
Placebo
n=319 Participants
Participants self-administered HL036 placebo (vehicle solution) as topical ophthalmic drops, BID for up to 8 weeks. Exposures to the CAE® were conducted at Day 1, Day 15, Day 29 and Day 57.
|
0.25% HL036 Ophthalmic Solution
n=318 Participants
Participants self-administered HL036 0.25 % ophthalmic solution as topical ophthalmic drops BID for up to 8 weeks. Exposures to the CAE® were conducted at Day 1, Day 15, Day 29 and Day 57.
|
|---|---|---|
|
Mean Change From Baseline in Lissamine Green Staining Score (Inferior Region)
Day 1 Pre-CAE
|
1.12 score on a scale
Standard Deviation 0.754
|
1.03 score on a scale
Standard Deviation 0.720
|
|
Mean Change From Baseline in Lissamine Green Staining Score (Inferior Region)
Day 1 Post-CAE
|
1.72 score on a scale
Standard Deviation 1.008
|
1.71 score on a scale
Standard Deviation 1.084
|
|
Mean Change From Baseline in Lissamine Green Staining Score (Inferior Region)
Day 1 (Change from Pre-CAE to Post-CAE)
|
0.60 score on a scale
Standard Deviation 0.922
|
0.67 score on a scale
Standard Deviation 0.918
|
|
Mean Change From Baseline in Lissamine Green Staining Score (Inferior Region)
Change from Baseline: Day 8
|
-0.05 score on a scale
Standard Deviation 0.799
|
0.03 score on a scale
Standard Deviation 0.771
|
|
Mean Change From Baseline in Lissamine Green Staining Score (Inferior Region)
Change from Baseline: Day 15 (Pre-CAE)
|
-0.13 score on a scale
Standard Deviation 0.796
|
-0.08 score on a scale
Standard Deviation 0.723
|
|
Mean Change From Baseline in Lissamine Green Staining Score (Inferior Region)
Change from Baseline: Day 15 (Post-CAE)
|
-0.18 score on a scale
Standard Deviation 1.045
|
-0.14 score on a scale
Standard Deviation 1.035
|
|
Mean Change From Baseline in Lissamine Green Staining Score (Inferior Region)
Change from baseline: Day 15 (Change from Pre-CAE to Post-CAE)
|
-0.05 score on a scale
Standard Deviation 1.207
|
-0.05 score on a scale
Standard Deviation 1.088
|
|
Mean Change From Baseline in Lissamine Green Staining Score (Inferior Region)
Change from Baseline: Day 29 (Pre-CAE)
|
-0.21 score on a scale
Standard Deviation 0.812
|
-0.09 score on a scale
Standard Deviation 0.725
|
|
Mean Change From Baseline in Lissamine Green Staining Score (Inferior Region)
Change from Baseline: Day 29 (Post-CAE)
|
-0.19 score on a scale
Standard Deviation 1.041
|
-0.15 score on a scale
Standard Deviation 1.071
|
|
Mean Change From Baseline in Lissamine Green Staining Score (Inferior Region)
Change from baseline: Day 29 (Change from Pre-CAE to Post-CAE)
|
0.01 score on a scale
Standard Deviation 1.169
|
-0.07 score on a scale
Standard Deviation 1.078
|
|
Mean Change From Baseline in Lissamine Green Staining Score (Inferior Region)
Change from Baseline: Day 57 (Pre-CAE)
|
-0.21 score on a scale
Standard Deviation 0.793
|
-0.11 score on a scale
Standard Deviation 0.744
|
|
Mean Change From Baseline in Lissamine Green Staining Score (Inferior Region)
Change from Baseline: Day 57 (Post-CAE)
|
-0.25 score on a scale
Standard Deviation 0.953
|
-0.20 score on a scale
Standard Deviation 1.015
|
|
Mean Change From Baseline in Lissamine Green Staining Score (Inferior Region)
Change from baseline: Day 57 (Change from Pre-CAE to Post-CAE)
|
-0.03 score on a scale
Standard Deviation 1.142
|
-0.09 score on a scale
Standard Deviation 1.064
|
SECONDARY outcome
Timeframe: Baseline (Day 1 Pre-CAE and Post-CAE), Day 8, Day 15 (Pre-CAE and Post-CAE), Day 29 (Pre-CAE and Post-CAE), and Day 57 (Pre-CAE and Post-CAE)Population: Number of participants analyzed included participants in ITT Population with available data. The analysis was carried out with observed data only.
It is evaluated for the superior region on the lissamine green corneal and conjunctival staining scale (Ora Calibra® scale). The score ranges from 0 to 4 (0=none and 4=severe), and lower score indicates improvement. Change score from pre- to post-CAE® was calculated as post-CAE® score - pre-CAE® score.
Outcome measures
| Measure |
Placebo
n=319 Participants
Participants self-administered HL036 placebo (vehicle solution) as topical ophthalmic drops, BID for up to 8 weeks. Exposures to the CAE® were conducted at Day 1, Day 15, Day 29 and Day 57.
|
0.25% HL036 Ophthalmic Solution
n=318 Participants
Participants self-administered HL036 0.25 % ophthalmic solution as topical ophthalmic drops BID for up to 8 weeks. Exposures to the CAE® were conducted at Day 1, Day 15, Day 29 and Day 57.
|
|---|---|---|
|
Mean Change From Baseline in Lissamine Green Staining Score (Superior Region)
Day 1 Pre-CAE
|
0.82 score on a scale
Standard Deviation 0.695
|
0.81 score on a scale
Standard Deviation 0.710
|
|
Mean Change From Baseline in Lissamine Green Staining Score (Superior Region)
Day 1 Post-CAE
|
0.98 score on a scale
Standard Deviation 0.820
|
0.96 score on a scale
Standard Deviation 0.806
|
|
Mean Change From Baseline in Lissamine Green Staining Score (Superior Region)
Day 1 (Change from Pre-CAE to Post-CAE)
|
0.17 score on a scale
Standard Deviation 0.569
|
0.15 score on a scale
Standard Deviation 0.587
|
|
Mean Change From Baseline in Lissamine Green Staining Score (Superior Region)
Change from Baseline: Day 8
|
-0.07 score on a scale
Standard Deviation 0.674
|
-0.04 score on a scale
Standard Deviation 0.662
|
|
Mean Change From Baseline in Lissamine Green Staining Score (Superior Region)
Change from Baseline: Day 15 (Pre-CAE)
|
-0.13 score on a scale
Standard Deviation 0.675
|
-0.13 score on a scale
Standard Deviation 0.660
|
|
Mean Change From Baseline in Lissamine Green Staining Score (Superior Region)
Change from Baseline: Day 15 (Post-CAE)
|
-0.13 score on a scale
Standard Deviation 0.739
|
-0.15 score on a scale
Standard Deviation 0.634
|
|
Mean Change From Baseline in Lissamine Green Staining Score (Superior Region)
Change from baseline: Day 15 (Change from Pre-CAE to Post-CAE)
|
0.01 score on a scale
Standard Deviation 0.780
|
-0.01 score on a scale
Standard Deviation 0.785
|
|
Mean Change From Baseline in Lissamine Green Staining Score (Superior Region)
Change from Baseline: Day 29 (Pre-CAE)
|
-0.18 score on a scale
Standard Deviation 0.639
|
-0.17 score on a scale
Standard Deviation 0.598
|
|
Mean Change From Baseline in Lissamine Green Staining Score (Superior Region)
Change from Baseline: Day 29 (Post-CAE)
|
-0.16 score on a scale
Standard Deviation 0.709
|
-0.17 score on a scale
Standard Deviation 0.644
|
|
Mean Change From Baseline in Lissamine Green Staining Score (Superior Region)
Change from baseline: Day 29 (Change from Pre-CAE to Post-CAE)
|
0.03 score on a scale
Standard Deviation 0.792
|
0.00 score on a scale
Standard Deviation 0.793
|
|
Mean Change From Baseline in Lissamine Green Staining Score (Superior Region)
Change from Baseline: Day 57 (Pre-CAE)
|
-0.18 score on a scale
Standard Deviation 0.606
|
-0.21 score on a scale
Standard Deviation 0.620
|
|
Mean Change From Baseline in Lissamine Green Staining Score (Superior Region)
Change from Baseline: Day 57 (Post-CAE)
|
-0.22 score on a scale
Standard Deviation 0.620
|
-0.18 score on a scale
Standard Deviation 0.605
|
|
Mean Change From Baseline in Lissamine Green Staining Score (Superior Region)
Change from baseline: Day 57 (Change from Pre-CAE to Post-CAE)
|
-0.03 score on a scale
Standard Deviation 0.805
|
0.03 score on a scale
Standard Deviation 0.780
|
SECONDARY outcome
Timeframe: Baseline (Day 1 Pre-CAE and Post-CAE), Day 8, Day 15 (Pre-CAE and Post-CAE), Day 29 (Pre-CAE and Post-CAE), and Day 57 (Pre-CAE and Post-CAE)Population: Number of participants analyzed included participants in ITT Population with available data. The analysis was carried out with observed data only.
It is evaluated for the central region on the lissamine green corneal and conjunctival staining scale (Ora Calibra® scale). The score ranges from 0 to 4 (0=none and 4=severe), and lower score indicates improvement. Change score from pre- to post-CAE® was calculated as post-CAE® score - pre-CAE® score.
Outcome measures
| Measure |
Placebo
n=319 Participants
Participants self-administered HL036 placebo (vehicle solution) as topical ophthalmic drops, BID for up to 8 weeks. Exposures to the CAE® were conducted at Day 1, Day 15, Day 29 and Day 57.
|
0.25% HL036 Ophthalmic Solution
n=318 Participants
Participants self-administered HL036 0.25 % ophthalmic solution as topical ophthalmic drops BID for up to 8 weeks. Exposures to the CAE® were conducted at Day 1, Day 15, Day 29 and Day 57.
|
|---|---|---|
|
Mean Change From Baseline in Lissamine Green Staining Score (Central Region)
Day 1 Pre-CAE
|
0.39 score on a scale
Standard Deviation 0.646
|
0.39 score on a scale
Standard Deviation 0.691
|
|
Mean Change From Baseline in Lissamine Green Staining Score (Central Region)
Day 1 Post-CAE
|
0.57 score on a scale
Standard Deviation 0.731
|
0.55 score on a scale
Standard Deviation 0.698
|
|
Mean Change From Baseline in Lissamine Green Staining Score (Central Region)
Day 1 (Change from Pre-CAE to Post-CAE)
|
0.18 score on a scale
Standard Deviation 0.559
|
0.15 score on a scale
Standard Deviation 0.587
|
|
Mean Change From Baseline in Lissamine Green Staining Score (Central Region)
Change from Baseline: Day 8
|
-0.04 score on a scale
Standard Deviation 0.625
|
-0.02 score on a scale
Standard Deviation 0.662
|
|
Mean Change From Baseline in Lissamine Green Staining Score (Central Region)
Change from Baseline: Day 15 (Pre-CAE)
|
-0.04 score on a scale
Standard Deviation 0.663
|
-0.11 score on a scale
Standard Deviation 0.620
|
|
Mean Change From Baseline in Lissamine Green Staining Score (Central Region)
Change from Baseline: Day 15 (Post-CAE)
|
-0.08 score on a scale
Standard Deviation 0.698
|
-0.08 score on a scale
Standard Deviation 0.631
|
|
Mean Change From Baseline in Lissamine Green Staining Score (Central Region)
Change from baseline: Day 15 (Change from Pre-CAE to Post-CAE)
|
-0.04 score on a scale
Standard Deviation 0.788
|
0.02 score on a scale
Standard Deviation 0.705
|
|
Mean Change From Baseline in Lissamine Green Staining Score (Central Region)
Change from Baseline: Day 29 (Pre-CAE)
|
-0.08 score on a scale
Standard Deviation 0.586
|
-0.11 score on a scale
Standard Deviation 0.671
|
|
Mean Change From Baseline in Lissamine Green Staining Score (Central Region)
Change from Baseline: Day 29 (Post-CAE)
|
-0.17 score on a scale
Standard Deviation 0.616
|
-0.12 score on a scale
Standard Deviation 0.554
|
|
Mean Change From Baseline in Lissamine Green Staining Score (Central Region)
Change from baseline: Day 29 (Change from Pre-CAE to Post-CAE)
|
-0.09 score on a scale
Standard Deviation 0.683
|
-0.02 score on a scale
Standard Deviation 0.784
|
|
Mean Change From Baseline in Lissamine Green Staining Score (Central Region)
Change from Baseline: Day 57 (Pre-CAE)
|
-0.12 score on a scale
Standard Deviation 0.608
|
-0.16 score on a scale
Standard Deviation 0.650
|
|
Mean Change From Baseline in Lissamine Green Staining Score (Central Region)
Change from Baseline: Day 57 (Post-CAE)
|
-0.17 score on a scale
Standard Deviation 0.595
|
-0.17 score on a scale
Standard Deviation 0.623
|
|
Mean Change From Baseline in Lissamine Green Staining Score (Central Region)
Change from baseline: Day 57 (Change from Pre-CAE to Post-CAE)
|
-0.05 score on a scale
Standard Deviation 0.783
|
-0.01 score on a scale
Standard Deviation 0.749
|
SECONDARY outcome
Timeframe: Baseline (Day 1 Pre-CAE and Post-CAE), Day 8, Day 15 (Pre-CAE and Post-CAE), Day 29 (Pre-CAE and Post-CAE), and Day 57 (Pre-CAE and Post-CAE)Population: Number of participants analyzed included participants in ITT Population with available data. The analysis was carried out with observed data only.
It is evaluated for the temporal region on the lissamine green corneal and conjunctival staining scale (Ora Calibra® scale). The score ranges from 0 to 4 (0=none and 4=severe), and lower score indicates improvement. Change score from pre- to post-CAE® was calculated as post-CAE® score - pre-CAE® score.
Outcome measures
| Measure |
Placebo
n=319 Participants
Participants self-administered HL036 placebo (vehicle solution) as topical ophthalmic drops, BID for up to 8 weeks. Exposures to the CAE® were conducted at Day 1, Day 15, Day 29 and Day 57.
|
0.25% HL036 Ophthalmic Solution
n=318 Participants
Participants self-administered HL036 0.25 % ophthalmic solution as topical ophthalmic drops BID for up to 8 weeks. Exposures to the CAE® were conducted at Day 1, Day 15, Day 29 and Day 57.
|
|---|---|---|
|
Mean Change From Baseline in Lissamine Green Staining Score (Temporal Region)
Day 1 Pre-CAE
|
1.35 score on a scale
Standard Deviation 0.759
|
1.29 score on a scale
Standard Deviation 0.734
|
|
Mean Change From Baseline in Lissamine Green Staining Score (Temporal Region)
Day 1 Post-CAE
|
1.55 score on a scale
Standard Deviation 0.850
|
1.47 score on a scale
Standard Deviation 0.798
|
|
Mean Change From Baseline in Lissamine Green Staining Score (Temporal Region)
Day 1 (Change from Pre-CAE to Post-CAE)
|
0.21 score on a scale
Standard Deviation 0.752
|
0.18 score on a scale
Standard Deviation 0.601
|
|
Mean Change From Baseline in Lissamine Green Staining Score (Temporal Region)
Change from Baseline: Day 8
|
-0.07 score on a scale
Standard Deviation 0.811
|
-0.12 score on a scale
Standard Deviation 0.708
|
|
Mean Change From Baseline in Lissamine Green Staining Score (Temporal Region)
Change from Baseline: Day 15 (Pre-CAE)
|
-0.18 score on a scale
Standard Deviation 0.806
|
-0.14 score on a scale
Standard Deviation 0.733
|
|
Mean Change From Baseline in Lissamine Green Staining Score (Temporal Region)
Change from Baseline: Day 15 (Post-CAE)
|
-0.23 score on a scale
Standard Deviation 0.715
|
-0.11 score on a scale
Standard Deviation 0.714
|
|
Mean Change From Baseline in Lissamine Green Staining Score (Temporal Region)
Change from baseline: Day 15 (Change from Pre-CAE to Post-CAE)
|
-0.07 score on a scale
Standard Deviation 0.887
|
0.03 score on a scale
Standard Deviation 0.865
|
|
Mean Change From Baseline in Lissamine Green Staining Score (Temporal Region)
Change from Baseline: Day 29 (Pre-CAE)
|
-0.19 score on a scale
Standard Deviation 0.827
|
-0.21 score on a scale
Standard Deviation 0.687
|
|
Mean Change From Baseline in Lissamine Green Staining Score (Temporal Region)
Change from Baseline: Day 29 (Post-CAE)
|
-0.29 score on a scale
Standard Deviation 0.780
|
-0.22 score on a scale
Standard Deviation 0.659
|
|
Mean Change From Baseline in Lissamine Green Staining Score (Temporal Region)
Change from baseline: Day 29 (Change from Pre-CAE to Post-CAE)
|
-0.09 score on a scale
Standard Deviation 0.918
|
-0.03 score on a scale
Standard Deviation 0.811
|
|
Mean Change From Baseline in Lissamine Green Staining Score (Temporal Region)
Change from Baseline: Day 57 (Pre-CAE)
|
-0.21 score on a scale
Standard Deviation 0.817
|
-0.18 score on a scale
Standard Deviation 0.774
|
|
Mean Change From Baseline in Lissamine Green Staining Score (Temporal Region)
Change from Baseline: Day 57 (Post-CAE)
|
-0.23 score on a scale
Standard Deviation 0.822
|
-0.18 score on a scale
Standard Deviation 0.774
|
|
Mean Change From Baseline in Lissamine Green Staining Score (Temporal Region)
Change from baseline: Day 57 (Change from Pre-CAE to Post-CAE)
|
-0.02 score on a scale
Standard Deviation 1.023
|
0.00 score on a scale
Standard Deviation 0.868
|
SECONDARY outcome
Timeframe: Baseline (Day 1 Pre-CAE and Post-CAE), Day 8, Day 15 (Pre-CAE and Post-CAE), Day 29 (Pre-CAE and Post-CAE), and Day 57 (Pre-CAE and Post-CAE)Population: Number of participants analyzed included participants in ITT Population with available data. The analysis was carried out with observed data only.
It is evaluated for the nasal region on the lissamine green corneal and conjunctival staining scale (Ora Calibra® scale). The score ranges from 0 to 4 (0=none and 4=severe), and lower score indicates improvement. Change score from pre- to post-CAE® was calculated as post-CAE® score - pre-CAE® score.
Outcome measures
| Measure |
Placebo
n=319 Participants
Participants self-administered HL036 placebo (vehicle solution) as topical ophthalmic drops, BID for up to 8 weeks. Exposures to the CAE® were conducted at Day 1, Day 15, Day 29 and Day 57.
|
0.25% HL036 Ophthalmic Solution
n=318 Participants
Participants self-administered HL036 0.25 % ophthalmic solution as topical ophthalmic drops BID for up to 8 weeks. Exposures to the CAE® were conducted at Day 1, Day 15, Day 29 and Day 57.
|
|---|---|---|
|
Mean Change From Baseline in Lissamine Green Staining Score (Nasal Region)
Day 1 Pre-CAE
|
1.48 score on a scale
Standard Deviation 0.823
|
1.51 score on a scale
Standard Deviation 0.852
|
|
Mean Change From Baseline in Lissamine Green Staining Score (Nasal Region)
Day 1 Post-CAE
|
1.82 score on a scale
Standard Deviation 0.915
|
1.80 score on a scale
Standard Deviation 0.903
|
|
Mean Change From Baseline in Lissamine Green Staining Score (Nasal Region)
Day 1 (Change from Pre-CAE to Post-CAE)
|
0.34 score on a scale
Standard Deviation 0.697
|
0.29 score on a scale
Standard Deviation 0.680
|
|
Mean Change From Baseline in Lissamine Green Staining Score (Nasal Region)
Change from Baseline: Day 8
|
-0.07 score on a scale
Standard Deviation 0.655
|
-0.09 score on a scale
Standard Deviation 0.732
|
|
Mean Change From Baseline in Lissamine Green Staining Score (Nasal Region)
Change from Baseline: Day 15 (Pre-CAE)
|
-0.16 score on a scale
Standard Deviation 0.695
|
-0.16 score on a scale
Standard Deviation 0.772
|
|
Mean Change From Baseline in Lissamine Green Staining Score (Nasal Region)
Change from Baseline: Day 15 (Post-CAE)
|
-0.23 score on a scale
Standard Deviation 0.729
|
-0.14 score on a scale
Standard Deviation 0.808
|
|
Mean Change From Baseline in Lissamine Green Staining Score (Nasal Region)
Change from baseline: Day 15 (Change from Pre-CAE to Post-CAE)
|
-0.09 score on a scale
Standard Deviation 0.830
|
0.03 score on a scale
Standard Deviation 0.894
|
|
Mean Change From Baseline in Lissamine Green Staining Score (Nasal Region)
Change from Baseline: Day 29 (Pre-CAE)
|
-0.22 score on a scale
Standard Deviation 0.690
|
-0.24 score on a scale
Standard Deviation 0.801
|
|
Mean Change From Baseline in Lissamine Green Staining Score (Nasal Region)
Change from Baseline: Day 29 (Post-CAE)
|
-0.37 score on a scale
Standard Deviation 0.810
|
-0.28 score on a scale
Standard Deviation 0.804
|
|
Mean Change From Baseline in Lissamine Green Staining Score (Nasal Region)
Change from baseline: Day 29 (Change from Pre-CAE to Post-CAE)
|
-0.16 score on a scale
Standard Deviation 0.905
|
-0.07 score on a scale
Standard Deviation 0.896
|
|
Mean Change From Baseline in Lissamine Green Staining Score (Nasal Region)
Change from Baseline: Day 57 (Pre-CAE)
|
-0.16 score on a scale
Standard Deviation 0.657
|
-0.17 score on a scale
Standard Deviation 0.751
|
|
Mean Change From Baseline in Lissamine Green Staining Score (Nasal Region)
Change from Baseline: Day 57 (Post-CAE)
|
-0.29 score on a scale
Standard Deviation 0.816
|
-0.20 score on a scale
Standard Deviation 0.898
|
|
Mean Change From Baseline in Lissamine Green Staining Score (Nasal Region)
Change from baseline: Day 57 (Change from Pre-CAE to Post-CAE)
|
-0.13 score on a scale
Standard Deviation 0.862
|
-0.04 score on a scale
Standard Deviation 0.985
|
SECONDARY outcome
Timeframe: Baseline (Day 1 Pre-CAE and Post-CAE), Day 8, Day 15 (Pre-CAE and Post-CAE), Day 29 (Pre-CAE and Post-CAE), and Day 57 (Pre-CAE and Post-CAE)Population: Number of participants analyzed included participants in ITT Population with available data. The analysis was carried out with observed data only.
Corneal sum score is the sum of all regions of the cornea (inferior, superior and central regions). Individual region score was evaluated on the lissamine green corneal and conjunctival staining scale (Ora Calibra® scale). Individual region score ranges from 0 to 4 (0=none and 4=severe), and lower score indicates improvement. Total score ranges from 0 to 12. Change score from pre- to post-CAE® was calculated as post-CAE® score - pre-CAE® score.
Outcome measures
| Measure |
Placebo
n=319 Participants
Participants self-administered HL036 placebo (vehicle solution) as topical ophthalmic drops, BID for up to 8 weeks. Exposures to the CAE® were conducted at Day 1, Day 15, Day 29 and Day 57.
|
0.25% HL036 Ophthalmic Solution
n=318 Participants
Participants self-administered HL036 0.25 % ophthalmic solution as topical ophthalmic drops BID for up to 8 weeks. Exposures to the CAE® were conducted at Day 1, Day 15, Day 29 and Day 57.
|
|---|---|---|
|
Mean Change From Baseline in Lissamine Green Staining (Corneal Sum)
Day 1 Pre-CAE
|
2.33 score on a scale
Standard Deviation 1.621
|
2.24 score on a scale
Standard Deviation 1.711
|
|
Mean Change From Baseline in Lissamine Green Staining (Corneal Sum)
Day 1 Post-CAE
|
3.27 score on a scale
Standard Deviation 2.082
|
3.22 score on a scale
Standard Deviation 2.083
|
|
Mean Change From Baseline in Lissamine Green Staining (Corneal Sum)
Day 1 (Change from Pre-CAE to Post-CAE)
|
0.95 score on a scale
Standard Deviation 1.433
|
0.98 score on a scale
Standard Deviation 1.522
|
|
Mean Change From Baseline in Lissamine Green Staining (Corneal Sum)
Change from Baseline: Day 8
|
-0.16 score on a scale
Standard Deviation 1.644
|
-0.04 score on a scale
Standard Deviation 1.663
|
|
Mean Change From Baseline in Lissamine Green Staining (Corneal Sum)
Change from Baseline: Day 15 (Pre-CAE)
|
-0.30 score on a scale
Standard Deviation 1.599
|
-0.32 score on a scale
Standard Deviation 1.594
|
|
Mean Change From Baseline in Lissamine Green Staining (Corneal Sum)
Change from Baseline: Day 15 (Post-CAE)
|
-0.39 score on a scale
Standard Deviation 1.846
|
-0.37 score on a scale
Standard Deviation 1.696
|
|
Mean Change From Baseline in Lissamine Green Staining (Corneal Sum)
Change from baseline: Day 15 (Change from Pre-CAE to Post-CAE)
|
-0.08 score on a scale
Standard Deviation 1.933
|
-0.04 score on a scale
Standard Deviation 1.875
|
|
Mean Change From Baseline in Lissamine Green Staining (Corneal Sum)
Change from Baseline: Day 29 (Pre-CAE)
|
-0.47 score on a scale
Standard Deviation 1.555
|
-0.37 score on a scale
Standard Deviation 1.513
|
|
Mean Change From Baseline in Lissamine Green Staining (Corneal Sum)
Change from Baseline: Day 29 (Post-CAE)
|
-0.52 score on a scale
Standard Deviation 1.805
|
-0.44 score on a scale
Standard Deviation 1.688
|
|
Mean Change From Baseline in Lissamine Green Staining (Corneal Sum)
Change from baseline: Day 29 (Change from Pre-CAE to Post-CAE)
|
-0.05 score on a scale
Standard Deviation 1.884
|
-0.09 score on a scale
Standard Deviation 1.899
|
|
Mean Change From Baseline in Lissamine Green Staining (Corneal Sum)
Change from Baseline: Day 57 (Pre-CAE)
|
-0.51 score on a scale
Standard Deviation 1.473
|
-0.48 score on a scale
Standard Deviation 1.502
|
|
Mean Change From Baseline in Lissamine Green Staining (Corneal Sum)
Change from Baseline: Day 57 (Post-CAE)
|
-0.63 score on a scale
Standard Deviation 1.609
|
-0.55 score on a scale
Standard Deviation 1.676
|
|
Mean Change From Baseline in Lissamine Green Staining (Corneal Sum)
Change from baseline: Day 57 (Change from Pre-CAE to Post-CAE)
|
-0.12 score on a scale
Standard Deviation 1.900
|
-0.06 score on a scale
Standard Deviation 1.833
|
SECONDARY outcome
Timeframe: Baseline (Day 1 Pre-CAE and Post-CAE), Day 8, Day 15 (Pre-CAE and Post-CAE), Day 29 (Pre-CAE and Post-CAE), and Day 57 (Pre-CAE and Post-CAE)Population: Number of participants analyzed included participants in ITT Population with available data. The analysis was carried out with observed data only.
Conjunctival sum score is the sum of all regions of the conjunctiva (temporal and nasal regions). Individual region score was evaluated on the lissamine green corneal and conjunctival staining scale (Ora Calibra® scale). Individual region score ranges from 0 to 4 (0=none and 4=severe), and lower score indicates improvement. Total score ranges from 0 to 8. Change score from pre- to post-CAE® was calculated as post-CAE® score - pre-CAE® score.
Outcome measures
| Measure |
Placebo
n=319 Participants
Participants self-administered HL036 placebo (vehicle solution) as topical ophthalmic drops, BID for up to 8 weeks. Exposures to the CAE® were conducted at Day 1, Day 15, Day 29 and Day 57.
|
0.25% HL036 Ophthalmic Solution
n=318 Participants
Participants self-administered HL036 0.25 % ophthalmic solution as topical ophthalmic drops BID for up to 8 weeks. Exposures to the CAE® were conducted at Day 1, Day 15, Day 29 and Day 57.
|
|---|---|---|
|
Mean Change From Baseline in Lissamine Green Staining (Conjunctival Sum)
Change from baseline: Day 15 (Change from Pre-CAE to Post-CAE)
|
-0.16 score on a scale
Standard Deviation 1.351
|
0.05 score on a scale
Standard Deviation 1.442
|
|
Mean Change From Baseline in Lissamine Green Staining (Conjunctival Sum)
Change from Baseline: Day 29 (Pre-CAE)
|
-0.41 score on a scale
Standard Deviation 1.269
|
-0.44 score on a scale
Standard Deviation 1.263
|
|
Mean Change From Baseline in Lissamine Green Staining (Conjunctival Sum)
Change from Baseline: Day 29 (Post-CAE)
|
-0.67 score on a scale
Standard Deviation 1.261
|
-0.51 score on a scale
Standard Deviation 1.220
|
|
Mean Change From Baseline in Lissamine Green Staining (Conjunctival Sum)
Change from baseline: Day 29 (Change from Pre-CAE to Post-CAE)
|
-0.25 score on a scale
Standard Deviation 1.442
|
-0.10 score on a scale
Standard Deviation 1.409
|
|
Mean Change From Baseline in Lissamine Green Staining (Conjunctival Sum)
Day 1 Pre-CAE
|
2.83 score on a scale
Standard Deviation 1.436
|
2.81 score on a scale
Standard Deviation 1.428
|
|
Mean Change From Baseline in Lissamine Green Staining (Conjunctival Sum)
Day 1 Post-CAE
|
3.37 score on a scale
Standard Deviation 1.551
|
3.28 score on a scale
Standard Deviation 1.520
|
|
Mean Change From Baseline in Lissamine Green Staining (Conjunctival Sum)
Day 1 (Change from Pre-CAE to Post-CAE)
|
0.54 score on a scale
Standard Deviation 1.181
|
0.47 score on a scale
Standard Deviation 1.080
|
|
Mean Change From Baseline in Lissamine Green Staining (Conjunctival Sum)
Change from Baseline: Day 8
|
-0.15 score on a scale
Standard Deviation 1.241
|
-0.21 score on a scale
Standard Deviation 1.235
|
|
Mean Change From Baseline in Lissamine Green Staining (Conjunctival Sum)
Change from Baseline: Day 15 (Pre-CAE)
|
-0.34 score on a scale
Standard Deviation 1.335
|
-0.30 score on a scale
Standard Deviation 1.271
|
|
Mean Change From Baseline in Lissamine Green Staining (Conjunctival Sum)
Change from Baseline: Day 15 (Post-CAE)
|
-0.46 score on a scale
Standard Deviation 1.142
|
-0.25 score on a scale
Standard Deviation 1.232
|
|
Mean Change From Baseline in Lissamine Green Staining (Conjunctival Sum)
Change from Baseline: Day 57 (Pre-CAE)
|
-0.38 score on a scale
Standard Deviation 1.245
|
-0.35 score on a scale
Standard Deviation 1.315
|
|
Mean Change From Baseline in Lissamine Green Staining (Conjunctival Sum)
Change from Baseline: Day 57 (Post-CAE)
|
-0.51 score on a scale
Standard Deviation 1.383
|
-0.38 score on a scale
Standard Deviation 1.453
|
|
Mean Change From Baseline in Lissamine Green Staining (Conjunctival Sum)
Change from baseline: Day 57 (Change from Pre-CAE to Post-CAE)
|
-0.14 score on a scale
Standard Deviation 1.510
|
-0.04 score on a scale
Standard Deviation 1.581
|
SECONDARY outcome
Timeframe: Baseline (Day 1 Pre-CAE and Post-CAE), Day 8, Day 15 (Pre-CAE and Post-CAE), Day 29 (Pre-CAE and Post-CAE), and Day 57 (Pre-CAE and Post-CAE)Population: Number of participants analyzed included participants in ITT Population with available data. The analysis was carried out with observed data only.
Total score was sum of all 5 regions: central, superior, inferior, temporal, and nasal. Individual region score was evaluated on the lissamine green corneal and conjunctival staining scale (Ora Calibra® scale). Individual region score ranges from 0 to 4 (0=none and 4=severe), and lower score indicates improvement. Total score ranges from 0 to 20. Change score from pre- to post-CAE® was calculated as post-CAE® score - pre-CAE® score.
Outcome measures
| Measure |
Placebo
n=319 Participants
Participants self-administered HL036 placebo (vehicle solution) as topical ophthalmic drops, BID for up to 8 weeks. Exposures to the CAE® were conducted at Day 1, Day 15, Day 29 and Day 57.
|
0.25% HL036 Ophthalmic Solution
n=318 Participants
Participants self-administered HL036 0.25 % ophthalmic solution as topical ophthalmic drops BID for up to 8 weeks. Exposures to the CAE® were conducted at Day 1, Day 15, Day 29 and Day 57.
|
|---|---|---|
|
Mean Change From Baseline in Lissamine Green Staining Total Score (All Five Regions: Central, Superior, Inferior, Temporal, Nasal)
Change from Baseline: Day 29 (Pre-CAE)
|
-0.88 score on a scale
Standard Deviation 2.376
|
-0.82 score on a scale
Standard Deviation 2.302
|
|
Mean Change From Baseline in Lissamine Green Staining Total Score (All Five Regions: Central, Superior, Inferior, Temporal, Nasal)
Change from Baseline: Day 29 (Post-CAE)
|
-1.19 score on a scale
Standard Deviation 2.464
|
-0.94 score on a scale
Standard Deviation 2.389
|
|
Mean Change From Baseline in Lissamine Green Staining Total Score (All Five Regions: Central, Superior, Inferior, Temporal, Nasal)
Day 1 Pre-CAE
|
5.15 score on a scale
Standard Deviation 2.643
|
5.04 score on a scale
Standard Deviation 2.765
|
|
Mean Change From Baseline in Lissamine Green Staining Total Score (All Five Regions: Central, Superior, Inferior, Temporal, Nasal)
Day 1 Post-CAE
|
6.64 score on a scale
Standard Deviation 3.180
|
6.49 score on a scale
Standard Deviation 3.166
|
|
Mean Change From Baseline in Lissamine Green Staining Total Score (All Five Regions: Central, Superior, Inferior, Temporal, Nasal)
Day 1 (Change from Pre-CAE to Post-CAE)
|
1.49 score on a scale
Standard Deviation 2.067
|
1.45 score on a scale
Standard Deviation 2.111
|
|
Mean Change From Baseline in Lissamine Green Staining Total Score (All Five Regions: Central, Superior, Inferior, Temporal, Nasal)
Change from Baseline: Day 8
|
-0.31 score on a scale
Standard Deviation 2.468
|
-0.25 score on a scale
Standard Deviation 2.445
|
|
Mean Change From Baseline in Lissamine Green Staining Total Score (All Five Regions: Central, Superior, Inferior, Temporal, Nasal)
Change from Baseline: Day 15 (Pre-CAE)
|
-0.63 score on a scale
Standard Deviation 2.568
|
-0.62 score on a scale
Standard Deviation 2.435
|
|
Mean Change From Baseline in Lissamine Green Staining Total Score (All Five Regions: Central, Superior, Inferior, Temporal, Nasal)
Change from Baseline: Day 15 (Post-CAE)
|
-0.85 score on a scale
Standard Deviation 2.424
|
-0.62 score on a scale
Standard Deviation 2.384
|
|
Mean Change From Baseline in Lissamine Green Staining Total Score (All Five Regions: Central, Superior, Inferior, Temporal, Nasal)
Change from baseline: Day 15 (Change from Pre-CAE to Post-CAE)
|
-0.25 score on a scale
Standard Deviation 2.593
|
0.01 score on a scale
Standard Deviation 2.624
|
|
Mean Change From Baseline in Lissamine Green Staining Total Score (All Five Regions: Central, Superior, Inferior, Temporal, Nasal)
Change from baseline: Day 29 (Change from Pre-CAE to Post-CAE)
|
-0.30 score on a scale
Standard Deviation 2.555
|
-0.19 score on a scale
Standard Deviation 2.695
|
|
Mean Change From Baseline in Lissamine Green Staining Total Score (All Five Regions: Central, Superior, Inferior, Temporal, Nasal)
Change from Baseline: Day 57 (Pre-CAE)
|
-0.89 score on a scale
Standard Deviation 2.217
|
-0.83 score on a scale
Standard Deviation 2.366
|
|
Mean Change From Baseline in Lissamine Green Staining Total Score (All Five Regions: Central, Superior, Inferior, Temporal, Nasal)
Change from Baseline: Day 57 (Post-CAE)
|
-1.15 score on a scale
Standard Deviation 2.518
|
-0.93 score on a scale
Standard Deviation 2.586
|
|
Mean Change From Baseline in Lissamine Green Staining Total Score (All Five Regions: Central, Superior, Inferior, Temporal, Nasal)
Change from baseline: Day 57 (Change from Pre-CAE to Post-CAE)
|
-0.26 score on a scale
Standard Deviation 2.773
|
-0.11 score on a scale
Standard Deviation 2.812
|
SECONDARY outcome
Timeframe: Baseline (Day 1 Pre-CAE and Post-CAE), Day 8, Day 15 (Pre-CAE and Post-CAE), Day 29 (Pre-CAE and Post-CAE), and Day 57 (Pre-CAE and Post-CAE)Population: Number of participants analyzed included participants in ITT Population with available data. The analysis was carried out with observed data only.
It is evaluated by the Ora Calibra® conjunctival redness scale for dry eye. The score ranges from 0 to 4 (0=none and 4=severe), where lower score indicates improvement
Outcome measures
| Measure |
Placebo
n=319 Participants
Participants self-administered HL036 placebo (vehicle solution) as topical ophthalmic drops, BID for up to 8 weeks. Exposures to the CAE® were conducted at Day 1, Day 15, Day 29 and Day 57.
|
0.25% HL036 Ophthalmic Solution
n=318 Participants
Participants self-administered HL036 0.25 % ophthalmic solution as topical ophthalmic drops BID for up to 8 weeks. Exposures to the CAE® were conducted at Day 1, Day 15, Day 29 and Day 57.
|
|---|---|---|
|
Measure Title Change From Baseline in the Ora Calibra® Conjunctival Redness Scale
Day 1 Pre-CAE
|
1.55 score on a scale
Standard Deviation 0.617
|
1.53 score on a scale
Standard Deviation 0.588
|
|
Measure Title Change From Baseline in the Ora Calibra® Conjunctival Redness Scale
Day 1 Post-CAE
|
1.95 score on a scale
Standard Deviation 0.739
|
1.89 score on a scale
Standard Deviation 0.718
|
|
Measure Title Change From Baseline in the Ora Calibra® Conjunctival Redness Scale
Day 1 (Change from Pre-CAE to Post-CAE)
|
0.40 score on a scale
Standard Deviation 0.503
|
0.36 score on a scale
Standard Deviation 0.511
|
|
Measure Title Change From Baseline in the Ora Calibra® Conjunctival Redness Scale
Change from Baseline: Day 8
|
-0.10 score on a scale
Standard Deviation 0.528
|
-0.13 score on a scale
Standard Deviation 0.595
|
|
Measure Title Change From Baseline in the Ora Calibra® Conjunctival Redness Scale
Change from Baseline: Day 15 (Pre-CAE)
|
-0.18 score on a scale
Standard Deviation 0.596
|
-0.22 score on a scale
Standard Deviation 0.650
|
|
Measure Title Change From Baseline in the Ora Calibra® Conjunctival Redness Scale
Change from Baseline: Day 15 (Post-CAE)
|
-0.35 score on a scale
Standard Deviation 0.706
|
-0.37 score on a scale
Standard Deviation 0.691
|
|
Measure Title Change From Baseline in the Ora Calibra® Conjunctival Redness Scale
Change from baseline: Day 15 (Change from Pre-CAE to Post-CAE)
|
-0.17 score on a scale
Standard Deviation 0.578
|
-0.14 score on a scale
Standard Deviation 0.630
|
|
Measure Title Change From Baseline in the Ora Calibra® Conjunctival Redness Scale
Change from Baseline: Day 29 (Pre-CAE)
|
-0.16 score on a scale
Standard Deviation 0.607
|
-0.15 score on a scale
Standard Deviation 0.609
|
|
Measure Title Change From Baseline in the Ora Calibra® Conjunctival Redness Scale
Change from Baseline: Day 29 (Post-CAE)
|
-0.36 score on a scale
Standard Deviation 0.781
|
-0.31 score on a scale
Standard Deviation 0.729
|
|
Measure Title Change From Baseline in the Ora Calibra® Conjunctival Redness Scale
Change from baseline: Day 29 (Change from Pre-CAE to Post-CAE)
|
-0.18 score on a scale
Standard Deviation 0.620
|
-0.17 score on a scale
Standard Deviation 0.666
|
|
Measure Title Change From Baseline in the Ora Calibra® Conjunctival Redness Scale
Change from Baseline: Day 57 (Pre-CAE)
|
-0.05 score on a scale
Standard Deviation 0.494
|
0.04 score on a scale
Standard Deviation 0.565
|
|
Measure Title Change From Baseline in the Ora Calibra® Conjunctival Redness Scale
Change from Baseline: Day 57 (Post-CAE)
|
-0.26 score on a scale
Standard Deviation 0.561
|
-0.07 score on a scale
Standard Deviation 0.579
|
|
Measure Title Change From Baseline in the Ora Calibra® Conjunctival Redness Scale
Change from baseline: Day 57 (Change from Pre-CAE to Post-CAE)
|
-0.21 score on a scale
Standard Deviation 0.677
|
-0.10 score on a scale
Standard Deviation 0.656
|
SECONDARY outcome
Timeframe: Post CAE on baseline (Day 1) and Days 15, 29, and 57Population: Number of participants analyzed included participants in ITT Population with available data. The analysis was carried out with observed data only.
The Schirmer test strip will be placed in the lower temporal lid margin of each eye. Participants will be instructed to close their eyes and After 5 minutes have elapsed, The length of moistened area of schirmer strip will be recorded (mm) for each eye.
Outcome measures
| Measure |
Placebo
n=319 Participants
Participants self-administered HL036 placebo (vehicle solution) as topical ophthalmic drops, BID for up to 8 weeks. Exposures to the CAE® were conducted at Day 1, Day 15, Day 29 and Day 57.
|
0.25% HL036 Ophthalmic Solution
n=318 Participants
Participants self-administered HL036 0.25 % ophthalmic solution as topical ophthalmic drops BID for up to 8 weeks. Exposures to the CAE® were conducted at Day 1, Day 15, Day 29 and Day 57.
|
|---|---|---|
|
Change From Baseline in Schirmer's Test
Day 1 Post-CAE
|
4.9 mm
Standard Deviation 2.80
|
5.1 mm
Standard Deviation 2.80
|
|
Change From Baseline in Schirmer's Test
Change from Baseline: Day 15 (Post-CAE)
|
2.0 mm
Standard Deviation 5.69
|
1.2 mm
Standard Deviation 5.41
|
|
Change From Baseline in Schirmer's Test
Change from Baseline: Day 29 (Post-CAE)
|
1.2 mm
Standard Deviation 5.26
|
2.0 mm
Standard Deviation 6.14
|
|
Change From Baseline in Schirmer's Test
Change from Baseline: Day 57 (Post-CAE)
|
2.4 mm
Standard Deviation 6.12
|
3.2 mm
Standard Deviation 7.55
|
SECONDARY outcome
Timeframe: Baseline (Day 1 Pre-CAE and Post-CAE), Day 8, Day 15 (Pre-CAE and Post-CAE), Day 29 (Pre-CAE and Post-CAE), and Day 57 (Pre-CAE and Post-CAE)Population: Number of participants analyzed included participants in ITT Population with available data. The analysis was carried out with observed data only.
Sodium fluorescein solution was instilled into each eye and participants were instructed to blinked several times. The time it takes to form micelles from the time that the eye is opened was noted.
Outcome measures
| Measure |
Placebo
n=319 Participants
Participants self-administered HL036 placebo (vehicle solution) as topical ophthalmic drops, BID for up to 8 weeks. Exposures to the CAE® were conducted at Day 1, Day 15, Day 29 and Day 57.
|
0.25% HL036 Ophthalmic Solution
n=318 Participants
Participants self-administered HL036 0.25 % ophthalmic solution as topical ophthalmic drops BID for up to 8 weeks. Exposures to the CAE® were conducted at Day 1, Day 15, Day 29 and Day 57.
|
|---|---|---|
|
Change From Baseline in Tear Film Break-Up Time
Change from baseline: Day 57 (Change from Pre-CAE to Post-CAE)
|
0.246 seconds
Standard Deviation 1.6429
|
-0.085 seconds
Standard Deviation 1.3655
|
|
Change From Baseline in Tear Film Break-Up Time
Day 1 Pre-CAE
|
2.588 seconds
Standard Deviation 1.0003
|
2.482 seconds
Standard Deviation 0.8960
|
|
Change From Baseline in Tear Film Break-Up Time
Day 1 Post-CAE
|
2.504 seconds
Standard Deviation 0.9018
|
2.444 seconds
Standard Deviation 0.8056
|
|
Change From Baseline in Tear Film Break-Up Time
Day 1 (Change from Pre-CAE to Post-CAE)
|
-0.084 seconds
Standard Deviation 0.8608
|
-0.037 seconds
Standard Deviation 0.7530
|
|
Change From Baseline in Tear Film Break-Up Time
Change from Baseline: Day 8
|
0.190 seconds
Standard Deviation 1.1859
|
0.175 seconds
Standard Deviation 1.2459
|
|
Change From Baseline in Tear Film Break-Up Time
Change from Baseline: Day 15 (Pre-CAE)
|
0.368 seconds
Standard Deviation 1.3630
|
0.276 seconds
Standard Deviation 1.4305
|
|
Change From Baseline in Tear Film Break-Up Time
Change from Baseline: Day 15 (Post-CAE)
|
0.348 seconds
Standard Deviation 1.2850
|
0.340 seconds
Standard Deviation 1.4089
|
|
Change From Baseline in Tear Film Break-Up Time
Change from baseline: Day 15 (Change from Pre-CAE to Post-CAE)
|
-0.021 seconds
Standard Deviation 1.2701
|
0.058 seconds
Standard Deviation 1.2997
|
|
Change From Baseline in Tear Film Break-Up Time
Change from Baseline: Day 29 (Pre-CAE)
|
0.352 seconds
Standard Deviation 1.5754
|
0.311 seconds
Standard Deviation 1.3669
|
|
Change From Baseline in Tear Film Break-Up Time
Change from Baseline: Day 29 (Post-CAE)
|
0.302 seconds
Standard Deviation 1.2757
|
0.222 seconds
Standard Deviation 1.1373
|
|
Change From Baseline in Tear Film Break-Up Time
Change from baseline: Day 29 (Change from Pre-CAE to Post-CAE)
|
-0.071 seconds
Standard Deviation 1.2797
|
-0.125 seconds
Standard Deviation 1.1118
|
|
Change From Baseline in Tear Film Break-Up Time
Change from Baseline: Day 57 (Pre-CAE)
|
0.478 seconds
Standard Deviation 1.2693
|
0.610 seconds
Standard Deviation 1.3934
|
|
Change From Baseline in Tear Film Break-Up Time
Change from Baseline: Day 57 (Post-CAE)
|
0.726 seconds
Standard Deviation 1.6787
|
0.523 seconds
Standard Deviation 1.1321
|
SECONDARY outcome
Timeframe: Pre-CAE on baseline (Day 1) and Days 15, 29, and 57; Day 8Population: Number of participants analyzed included participants in ITT Population with available data. The analysis was carried out with observed data only.
The OSDI is a simple 12-question survey that rates the severity of the participant's dry eye disease based on the symptoms. It is assessed on a scale of 0 to 100, with higher score representing greater disability.
Outcome measures
| Measure |
Placebo
n=319 Participants
Participants self-administered HL036 placebo (vehicle solution) as topical ophthalmic drops, BID for up to 8 weeks. Exposures to the CAE® were conducted at Day 1, Day 15, Day 29 and Day 57.
|
0.25% HL036 Ophthalmic Solution
n=318 Participants
Participants self-administered HL036 0.25 % ophthalmic solution as topical ophthalmic drops BID for up to 8 weeks. Exposures to the CAE® were conducted at Day 1, Day 15, Day 29 and Day 57.
|
|---|---|---|
|
Change From Baseline in Ocular Surface Disease Index (OSDI)
Day 1 Pre-CAE
|
39.2 score on a scale
Standard Deviation 19.33
|
39.7 score on a scale
Standard Deviation 19.68
|
|
Change From Baseline in Ocular Surface Disease Index (OSDI)
Change from Baseline: Day 8
|
-1.5 score on a scale
Standard Deviation 12.46
|
-2.0 score on a scale
Standard Deviation 12.50
|
|
Change From Baseline in Ocular Surface Disease Index (OSDI)
Change from Baseline: Day 15 (Pre-CAE)
|
-1.5 score on a scale
Standard Deviation 12.81
|
-2.7 score on a scale
Standard Deviation 12.07
|
|
Change From Baseline in Ocular Surface Disease Index (OSDI)
Change from Baseline: Day 29 (Pre-CAE)
|
-2.2 score on a scale
Standard Deviation 13.95
|
-3.7 score on a scale
Standard Deviation 13.13
|
|
Change From Baseline in Ocular Surface Disease Index (OSDI)
Change from Baseline: Day 57 (Pre-CAE)
|
-5.3 score on a scale
Standard Deviation 13.93
|
-2.9 score on a scale
Standard Deviation 14.69
|
SECONDARY outcome
Timeframe: Baseline (Day 1 Pre-CAE and Post-CAE), Day 8, Day 15 (Pre-CAE and Post-CAE), Day 29 (Pre-CAE and Post-CAE), and Day 57 (Pre-CAE and Post-CAE)Population: Number of participants analyzed included participants in ITT Population with available data. The analysis was carried out with observed data only.
Participants rated ocular symptom of blurry vision by placing a vertical mark on the horizontal line to indicate the level of discomfort. 0 mm corresponds to "no discomfort" and 100 mm corresponds to "maximal discomfort."
Outcome measures
| Measure |
Placebo
n=319 Participants
Participants self-administered HL036 placebo (vehicle solution) as topical ophthalmic drops, BID for up to 8 weeks. Exposures to the CAE® were conducted at Day 1, Day 15, Day 29 and Day 57.
|
0.25% HL036 Ophthalmic Solution
n=318 Participants
Participants self-administered HL036 0.25 % ophthalmic solution as topical ophthalmic drops BID for up to 8 weeks. Exposures to the CAE® were conducted at Day 1, Day 15, Day 29 and Day 57.
|
|---|---|---|
|
Change From Baseline in Visual Analog Scale (Blurry Vision)
Day 1 Pre-CAE
|
32.9 mm
Standard Deviation 28.67
|
37.8 mm
Standard Deviation 28.41
|
|
Change From Baseline in Visual Analog Scale (Blurry Vision)
Day 1 Post-CAE
|
40.5 mm
Standard Deviation 29.68
|
43.7 mm
Standard Deviation 29.37
|
|
Change From Baseline in Visual Analog Scale (Blurry Vision)
Day 1 (Change from Pre-CAE to Post-CAE)
|
7.6 mm
Standard Deviation 18.80
|
5.9 mm
Standard Deviation 17.70
|
|
Change From Baseline in Visual Analog Scale (Blurry Vision)
Change from Baseline: Day 8
|
-0.8 mm
Standard Deviation 17.90
|
-2.4 mm
Standard Deviation 18.85
|
|
Change From Baseline in Visual Analog Scale (Blurry Vision)
Change from Baseline: Day 15 (Pre-CAE)
|
-1.3 mm
Standard Deviation 18.59
|
-2.8 mm
Standard Deviation 20.85
|
|
Change From Baseline in Visual Analog Scale (Blurry Vision)
Change from Baseline: Day 15 (Post-CAE)
|
-3.1 mm
Standard Deviation 18.99
|
-3.9 mm
Standard Deviation 20.70
|
|
Change From Baseline in Visual Analog Scale (Blurry Vision)
Change from baseline: Day 15 (Change from Pre-CAE to Post-CAE)
|
-2.1 mm
Standard Deviation 21.88
|
-0.9 mm
Standard Deviation 23.30
|
|
Change From Baseline in Visual Analog Scale (Blurry Vision)
Change from Baseline: Day 29 (Pre-CAE)
|
-1.3 mm
Standard Deviation 20.30
|
-3.9 mm
Standard Deviation 22.40
|
|
Change From Baseline in Visual Analog Scale (Blurry Vision)
Change from Baseline: Day 29 (Post-CAE)
|
-5.2 mm
Standard Deviation 21.84
|
-6.2 mm
Standard Deviation 22.30
|
|
Change From Baseline in Visual Analog Scale (Blurry Vision)
Change from baseline: Day 29 (Change from Pre-CAE to Post-CAE)
|
-3.9 mm
Standard Deviation 23.19
|
-2.3 mm
Standard Deviation 22.41
|
|
Change From Baseline in Visual Analog Scale (Blurry Vision)
Change from Baseline: Day 57 (Pre-CAE)
|
-5.7 mm
Standard Deviation 21.23
|
-6.5 mm
Standard Deviation 22.49
|
|
Change From Baseline in Visual Analog Scale (Blurry Vision)
Change from Baseline: Day 57 (Post-CAE)
|
-6.3 mm
Standard Deviation 24.68
|
-7.1 mm
Standard Deviation 24.39
|
|
Change From Baseline in Visual Analog Scale (Blurry Vision)
Change from baseline: Day 57 (Change from Pre-CAE to Post-CAE)
|
-0.2 mm
Standard Deviation 24.41
|
-0.3 mm
Standard Deviation 22.62
|
SECONDARY outcome
Timeframe: Baseline (Day 1 Pre-CAE and Post-CAE), Day 8, Day 15 (Pre-CAE and Post-CAE), Day 29 (Pre-CAE and Post-CAE), and Day 57 (Pre-CAE and Post-CAE)Population: Number of participants analyzed included participants in ITT Population with available data. The analysis was carried out with observed data only.
Participants rated ocular symptom of burning/stinging by placing a vertical mark on the horizontal line to indicate the level of discomfort. 0 mm corresponds to "no discomfort" and 100 mm corresponds to "maximal discomfort."
Outcome measures
| Measure |
Placebo
n=319 Participants
Participants self-administered HL036 placebo (vehicle solution) as topical ophthalmic drops, BID for up to 8 weeks. Exposures to the CAE® were conducted at Day 1, Day 15, Day 29 and Day 57.
|
0.25% HL036 Ophthalmic Solution
n=318 Participants
Participants self-administered HL036 0.25 % ophthalmic solution as topical ophthalmic drops BID for up to 8 weeks. Exposures to the CAE® were conducted at Day 1, Day 15, Day 29 and Day 57.
|
|---|---|---|
|
Change From Baseline in Visual Analog Scale (Burning/Stinging)
Day 1 Pre-CAE
|
35.6 mm
Standard Deviation 27.23
|
36.6 mm
Standard Deviation 28.19
|
|
Change From Baseline in Visual Analog Scale (Burning/Stinging)
Day 1 Post-CAE
|
47.1 mm
Standard Deviation 30.02
|
49.2 mm
Standard Deviation 31.81
|
|
Change From Baseline in Visual Analog Scale (Burning/Stinging)
Day 1 (Change from Pre-CAE to Post-CAE)
|
11.5 mm
Standard Deviation 23.00
|
12.6 mm
Standard Deviation 24.32
|
|
Change From Baseline in Visual Analog Scale (Burning/Stinging)
Change from Baseline: Day 8
|
-3.9 mm
Standard Deviation 19.55
|
-3.7 mm
Standard Deviation 18.86
|
|
Change From Baseline in Visual Analog Scale (Burning/Stinging)
Change from Baseline: Day 15 (Pre-CAE)
|
-5.7 mm
Standard Deviation 19.94
|
-4.9 mm
Standard Deviation 21.12
|
|
Change From Baseline in Visual Analog Scale (Burning/Stinging)
Change from Baseline: Day 15 (Post-CAE)
|
-4.5 mm
Standard Deviation 23.80
|
-5.2 mm
Standard Deviation 23.93
|
|
Change From Baseline in Visual Analog Scale (Burning/Stinging)
Change from baseline: Day 15 (Change from Pre-CAE to Post-CAE)
|
1.5 mm
Standard Deviation 24.77
|
-0.1 mm
Standard Deviation 26.13
|
|
Change From Baseline in Visual Analog Scale (Burning/Stinging)
Change from Baseline: Day 29 (Pre-CAE)
|
-5.4 mm
Standard Deviation 18.45
|
-6.5 mm
Standard Deviation 24.75
|
|
Change From Baseline in Visual Analog Scale (Burning/Stinging)
Change from Baseline: Day 29 (Post-CAE)
|
-5.4 mm
Standard Deviation 24.50
|
-5.2 mm
Standard Deviation 24.73
|
|
Change From Baseline in Visual Analog Scale (Burning/Stinging)
Change from baseline: Day 29 (Change from Pre-CAE to Post-CAE)
|
-0.6 mm
Standard Deviation 24.52
|
1.5 mm
Standard Deviation 29.65
|
|
Change From Baseline in Visual Analog Scale (Burning/Stinging)
Change from Baseline: Day 57 (Pre-CAE)
|
-9.1 mm
Standard Deviation 21.37
|
-7.6 mm
Standard Deviation 23.03
|
|
Change From Baseline in Visual Analog Scale (Burning/Stinging)
Change from Baseline: Day 57 (Post-CAE)
|
-7.4 mm
Standard Deviation 27.83
|
-6.8 mm
Standard Deviation 26.31
|
|
Change From Baseline in Visual Analog Scale (Burning/Stinging)
Change from baseline: Day 57 (Change from Pre-CAE to Post-CAE)
|
1.8 mm
Standard Deviation 29.03
|
1.1 mm
Standard Deviation 28.56
|
SECONDARY outcome
Timeframe: Baseline (Day 1 Pre-CAE and Post-CAE), Day 8, Day 15 (Pre-CAE and Post-CAE), Day 29 (Pre-CAE and Post-CAE), and Day 57 (Pre-CAE and Post-CAE)Population: Number of participants analyzed included participants in ITT Population with available data. The analysis was carried out with observed data only.
Participants rated ocular symptom of itching by placing a vertical mark on the horizontal line to indicate the level of discomfort. 0 mm corresponds to "no discomfort" and 100 mm corresponds to "maximal discomfort."
Outcome measures
| Measure |
Placebo
n=319 Participants
Participants self-administered HL036 placebo (vehicle solution) as topical ophthalmic drops, BID for up to 8 weeks. Exposures to the CAE® were conducted at Day 1, Day 15, Day 29 and Day 57.
|
0.25% HL036 Ophthalmic Solution
n=318 Participants
Participants self-administered HL036 0.25 % ophthalmic solution as topical ophthalmic drops BID for up to 8 weeks. Exposures to the CAE® were conducted at Day 1, Day 15, Day 29 and Day 57.
|
|---|---|---|
|
Change From Baseline in Visual Analog Scale (Itching)
Change from Baseline: Day 57 (Pre-CAE)
|
-8.3 mm
Standard Deviation 23.57
|
-8.0 mm
Standard Deviation 21.70
|
|
Change From Baseline in Visual Analog Scale (Itching)
Day 1 Pre-CAE
|
35.6 mm
Standard Deviation 27.53
|
35.9 mm
Standard Deviation 27.26
|
|
Change From Baseline in Visual Analog Scale (Itching)
Day 1 Post-CAE
|
39.6 mm
Standard Deviation 28.83
|
42.3 mm
Standard Deviation 30.44
|
|
Change From Baseline in Visual Analog Scale (Itching)
Day 1 (Change from Pre-CAE to Post-CAE)
|
4.0 mm
Standard Deviation 19.81
|
6.5 mm
Standard Deviation 21.23
|
|
Change From Baseline in Visual Analog Scale (Itching)
Change from Baseline: Day 8
|
-4.2 mm
Standard Deviation 19.66
|
-5.1 mm
Standard Deviation 20.76
|
|
Change From Baseline in Visual Analog Scale (Itching)
Change from Baseline: Day 15 (Pre-CAE)
|
-4.6 mm
Standard Deviation 21.02
|
-5.2 mm
Standard Deviation 22.62
|
|
Change From Baseline in Visual Analog Scale (Itching)
Change from Baseline: Day 15 (Post-CAE)
|
-3.7 mm
Standard Deviation 21.96
|
-7.1 mm
Standard Deviation 21.79
|
|
Change From Baseline in Visual Analog Scale (Itching)
Change from baseline: Day 15 (Change from Pre-CAE to Post-CAE)
|
1.0 mm
Standard Deviation 23.34
|
-2.0 mm
Standard Deviation 25.24
|
|
Change From Baseline in Visual Analog Scale (Itching)
Change from Baseline: Day 29 (Pre-CAE)
|
-5.9 mm
Standard Deviation 20.75
|
-8.4 mm
Standard Deviation 22.61
|
|
Change From Baseline in Visual Analog Scale (Itching)
Change from Baseline: Day 29 (Post-CAE)
|
-5.9 mm
Standard Deviation 22.57
|
-7.8 mm
Standard Deviation 24.13
|
|
Change From Baseline in Visual Analog Scale (Itching)
Change from baseline: Day 29 (Change from Pre-CAE to Post-CAE)
|
-0.4 mm
Standard Deviation 22.52
|
0.5 mm
Standard Deviation 26.78
|
|
Change From Baseline in Visual Analog Scale (Itching)
Change from Baseline: Day 57 (Post-CAE)
|
-7.2 mm
Standard Deviation 27.69
|
-8.9 mm
Standard Deviation 24.09
|
|
Change From Baseline in Visual Analog Scale (Itching)
Change from baseline: Day 57 (Change from Pre-CAE to Post-CAE)
|
1.3 mm
Standard Deviation 26.04
|
-0.8 mm
Standard Deviation 24.68
|
SECONDARY outcome
Timeframe: Baseline (Day 1 Pre-CAE and Post-CAE), Day 8, Day 15 (Pre-CAE and Post-CAE), Day 29 (Pre-CAE and Post-CAE), and Day 57 (Pre-CAE and Post-CAE)Population: Number of participants analyzed included participants in ITT Population with available data. The analysis was carried out with observed data only.
Participants rated ocular symptom of foreign body sensation by placing a vertical mark on the horizontal line to indicate the level of discomfort. 0 mm corresponds to "no discomfort" and 100 mm corresponds to "maximal discomfort."
Outcome measures
| Measure |
Placebo
n=319 Participants
Participants self-administered HL036 placebo (vehicle solution) as topical ophthalmic drops, BID for up to 8 weeks. Exposures to the CAE® were conducted at Day 1, Day 15, Day 29 and Day 57.
|
0.25% HL036 Ophthalmic Solution
n=318 Participants
Participants self-administered HL036 0.25 % ophthalmic solution as topical ophthalmic drops BID for up to 8 weeks. Exposures to the CAE® were conducted at Day 1, Day 15, Day 29 and Day 57.
|
|---|---|---|
|
Change From Baseline in Visual Analog Scale (Foreign Body Sensation)
Day 1 Pre-CAE
|
36.6 mm
Standard Deviation 28.81
|
37.8 mm
Standard Deviation 28.96
|
|
Change From Baseline in Visual Analog Scale (Foreign Body Sensation)
Day 1 Post-CAE
|
42.9 mm
Standard Deviation 30.08
|
47.5 mm
Standard Deviation 30.70
|
|
Change From Baseline in Visual Analog Scale (Foreign Body Sensation)
Day 1 (Change from Pre-CAE to Post-CAE)
|
6.3 mm
Standard Deviation 19.33
|
9.7 mm
Standard Deviation 21.96
|
|
Change From Baseline in Visual Analog Scale (Foreign Body Sensation)
Change from Baseline: Day 8
|
-3.6 mm
Standard Deviation 21.88
|
-3.9 mm
Standard Deviation 19.98
|
|
Change From Baseline in Visual Analog Scale (Foreign Body Sensation)
Change from Baseline: Day 15 (Pre-CAE)
|
-5.6 mm
Standard Deviation 21.37
|
-5.5 mm
Standard Deviation 21.35
|
|
Change From Baseline in Visual Analog Scale (Foreign Body Sensation)
Change from Baseline: Day 15 (Post-CAE)
|
-2.9 mm
Standard Deviation 21.23
|
-7.9 mm
Standard Deviation 24.27
|
|
Change From Baseline in Visual Analog Scale (Foreign Body Sensation)
Change from baseline: Day 15 (Change from Pre-CAE to Post-CAE)
|
2.5 mm
Standard Deviation 23.43
|
-2.1 mm
Standard Deviation 25.53
|
|
Change From Baseline in Visual Analog Scale (Foreign Body Sensation)
Change from Baseline: Day 29 (Pre-CAE)
|
-4.7 mm
Standard Deviation 22.85
|
-6.9 mm
Standard Deviation 24.63
|
|
Change From Baseline in Visual Analog Scale (Foreign Body Sensation)
Change from Baseline: Day 29 (Post-CAE)
|
-4.0 mm
Standard Deviation 22.44
|
-9.0 mm
Standard Deviation 26.10
|
|
Change From Baseline in Visual Analog Scale (Foreign Body Sensation)
Change from baseline: Day 29 (Change from Pre-CAE to Post-CAE)
|
0.6 mm
Standard Deviation 22.51
|
-2.0 mm
Standard Deviation 28.75
|
|
Change From Baseline in Visual Analog Scale (Foreign Body Sensation)
Change from Baseline: Day 57 (Pre-CAE)
|
-8.2 mm
Standard Deviation 22.70
|
-7.6 mm
Standard Deviation 23.30
|
|
Change From Baseline in Visual Analog Scale (Foreign Body Sensation)
Change from Baseline: Day 57 (Post-CAE)
|
-5.6 mm
Standard Deviation 26.82
|
-9.1 mm
Standard Deviation 25.32
|
|
Change From Baseline in Visual Analog Scale (Foreign Body Sensation)
Change from baseline: Day 57 (Change from Pre-CAE to Post-CAE)
|
2.9 mm
Standard Deviation 25.60
|
-0.9 mm
Standard Deviation 26.40
|
SECONDARY outcome
Timeframe: Baseline (Day 1 Pre-CAE and Post-CAE), Day 8, Day 15 (Pre-CAE and Post-CAE), Day 29 (Pre-CAE and Post-CAE), and Day 57 (Pre-CAE and Post-CAE)Population: Number of participants analyzed included participants in ITT Population with available data. The analysis was carried out with observed data only.
Participants rated ocular symptom of eye dryness by placing a vertical mark on the horizontal line to indicate the level of discomfort. 0 mm corresponds to "no discomfort" and 100 mm corresponds to "maximal discomfort."
Outcome measures
| Measure |
Placebo
n=319 Participants
Participants self-administered HL036 placebo (vehicle solution) as topical ophthalmic drops, BID for up to 8 weeks. Exposures to the CAE® were conducted at Day 1, Day 15, Day 29 and Day 57.
|
0.25% HL036 Ophthalmic Solution
n=318 Participants
Participants self-administered HL036 0.25 % ophthalmic solution as topical ophthalmic drops BID for up to 8 weeks. Exposures to the CAE® were conducted at Day 1, Day 15, Day 29 and Day 57.
|
|---|---|---|
|
Change From Baseline in Visual Analog Scale (Eye Dryness)
Day 1 (Change from Pre-CAE to Post-CAE)
|
12.7 mm
Standard Deviation 18.58
|
13.1 mm
Standard Deviation 20.49
|
|
Change From Baseline in Visual Analog Scale (Eye Dryness)
Change from Baseline: Day 8
|
-3.7 mm
Standard Deviation 19.20
|
-5.5 mm
Standard Deviation 19.57
|
|
Change From Baseline in Visual Analog Scale (Eye Dryness)
Change from baseline: Day 57 (Change from Pre-CAE to Post-CAE)
|
1.2 mm
Standard Deviation 24.96
|
2.3 mm
Standard Deviation 25.84
|
|
Change From Baseline in Visual Analog Scale (Eye Dryness)
Day 1 Pre-CAE
|
59.7 mm
Standard Deviation 24.58
|
61.4 mm
Standard Deviation 24.71
|
|
Change From Baseline in Visual Analog Scale (Eye Dryness)
Day 1 Post-CAE
|
72.4 mm
Standard Deviation 21.45
|
74.4 mm
Standard Deviation 22.20
|
|
Change From Baseline in Visual Analog Scale (Eye Dryness)
Change from Baseline: Day 15 (Pre-CAE)
|
-6.8 mm
Standard Deviation 19.33
|
-7.7 mm
Standard Deviation 21.44
|
|
Change From Baseline in Visual Analog Scale (Eye Dryness)
Change from Baseline: Day 15 (Post-CAE)
|
-5.0 mm
Standard Deviation 17.45
|
-5.4 mm
Standard Deviation 17.94
|
|
Change From Baseline in Visual Analog Scale (Eye Dryness)
Change from baseline: Day 15 (Change from Pre-CAE to Post-CAE)
|
1.9 mm
Standard Deviation 20.81
|
2.5 mm
Standard Deviation 23.52
|
|
Change From Baseline in Visual Analog Scale (Eye Dryness)
Change from Baseline: Day 29 (Pre-CAE)
|
-7.4 mm
Standard Deviation 22.31
|
-9.8 mm
Standard Deviation 23.24
|
|
Change From Baseline in Visual Analog Scale (Eye Dryness)
Change from Baseline: Day 29 (Post-CAE)
|
-6.9 mm
Standard Deviation 19.91
|
-7.4 mm
Standard Deviation 20.28
|
|
Change From Baseline in Visual Analog Scale (Eye Dryness)
Change from baseline: Day 29 (Change from Pre-CAE to Post-CAE)
|
0.6 mm
Standard Deviation 21.09
|
2.6 mm
Standard Deviation 25.92
|
|
Change From Baseline in Visual Analog Scale (Eye Dryness)
Change from Baseline: Day 57 (Pre-CAE)
|
-11.3 mm
Standard Deviation 23.01
|
-12.9 mm
Standard Deviation 24.74
|
|
Change From Baseline in Visual Analog Scale (Eye Dryness)
Change from Baseline: Day 57 (Post-CAE)
|
-10.3 mm
Standard Deviation 24.63
|
-10.6 mm
Standard Deviation 22.58
|
SECONDARY outcome
Timeframe: Baseline (Day 1 Pre-CAE and Post-CAE), Day 8, Day 15 (Pre-CAE and Post-CAE), Day 29 (Pre-CAE and Post-CAE), and Day 57 (Pre-CAE and Post-CAE)Population: Number of participants analyzed included participants in ITT Population with available data. The analysis was carried out with observed data only.
Participants rated ocular symptom of photophobia by placing a vertical mark on the horizontal line to indicate the level of discomfort. 0 mm corresponds to "no discomfort" and 100 mm corresponds to "maximal discomfort."
Outcome measures
| Measure |
Placebo
n=319 Participants
Participants self-administered HL036 placebo (vehicle solution) as topical ophthalmic drops, BID for up to 8 weeks. Exposures to the CAE® were conducted at Day 1, Day 15, Day 29 and Day 57.
|
0.25% HL036 Ophthalmic Solution
n=318 Participants
Participants self-administered HL036 0.25 % ophthalmic solution as topical ophthalmic drops BID for up to 8 weeks. Exposures to the CAE® were conducted at Day 1, Day 15, Day 29 and Day 57.
|
|---|---|---|
|
Change From Baseline in Visual Analog Scale (Photophobia)
Change from baseline: Day 15 (Change from Pre-CAE to Post-CAE)
|
-1.3 mm
Standard Deviation 20.38
|
-0.4 mm
Standard Deviation 22.09
|
|
Change From Baseline in Visual Analog Scale (Photophobia)
Change from Baseline: Day 29 (Pre-CAE)
|
-4.9 mm
Standard Deviation 21.05
|
-6.3 mm
Standard Deviation 20.75
|
|
Change From Baseline in Visual Analog Scale (Photophobia)
Day 1 Pre-CAE
|
37.8 mm
Standard Deviation 30.73
|
40.4 mm
Standard Deviation 30.20
|
|
Change From Baseline in Visual Analog Scale (Photophobia)
Day 1 Post-CAE
|
43.5 mm
Standard Deviation 30.48
|
46.0 mm
Standard Deviation 31.33
|
|
Change From Baseline in Visual Analog Scale (Photophobia)
Day 1 (Change from Pre-CAE to Post-CAE)
|
5.7 mm
Standard Deviation 17.70
|
5.6 mm
Standard Deviation 19.67
|
|
Change From Baseline in Visual Analog Scale (Photophobia)
Change from Baseline: Day 8
|
-3.6 mm
Standard Deviation 17.03
|
-3.2 mm
Standard Deviation 16.91
|
|
Change From Baseline in Visual Analog Scale (Photophobia)
Change from Baseline: Day 15 (Pre-CAE)
|
-3.6 mm
Standard Deviation 18.58
|
-3.4 mm
Standard Deviation 18.66
|
|
Change From Baseline in Visual Analog Scale (Photophobia)
Change from Baseline: Day 15 (Post-CAE)
|
-4.9 mm
Standard Deviation 22.13
|
-4.0 mm
Standard Deviation 21.77
|
|
Change From Baseline in Visual Analog Scale (Photophobia)
Change from Baseline: Day 29 (Post-CAE)
|
-7.0 mm
Standard Deviation 23.42
|
-6.5 mm
Standard Deviation 21.85
|
|
Change From Baseline in Visual Analog Scale (Photophobia)
Change from baseline: Day 29 (Change from Pre-CAE to Post-CAE)
|
-2.1 mm
Standard Deviation 22.44
|
0.0 mm
Standard Deviation 22.25
|
|
Change From Baseline in Visual Analog Scale (Photophobia)
Change from Baseline: Day 57 (Pre-CAE)
|
-7.6 mm
Standard Deviation 20.66
|
-7.4 mm
Standard Deviation 21.60
|
|
Change From Baseline in Visual Analog Scale (Photophobia)
Change from Baseline: Day 57 (Post-CAE)
|
-9.5 mm
Standard Deviation 23.72
|
-8.2 mm
Standard Deviation 22.51
|
|
Change From Baseline in Visual Analog Scale (Photophobia)
Change from baseline: Day 57 (Change from Pre-CAE to Post-CAE)
|
-1.9 mm
Standard Deviation 22.26
|
-0.4 mm
Standard Deviation 22.72
|
SECONDARY outcome
Timeframe: Baseline (Day 1 Pre-CAE and Post-CAE), Day 8, Day 15 (Pre-CAE and Post-CAE), Day 29 (Pre-CAE and Post-CAE), and Day 57 (Pre-CAE and Post-CAE)Population: Number of participants analyzed included participants in ITT Population with available data. The analysis was carried out with observed data only.
Participants rated ocular symptom of pain by placing a vertical mark on the horizontal line to indicate the level of discomfort. 0 mm corresponds to "no discomfort" and 100 mm corresponds to "maximal discomfort."
Outcome measures
| Measure |
Placebo
n=319 Participants
Participants self-administered HL036 placebo (vehicle solution) as topical ophthalmic drops, BID for up to 8 weeks. Exposures to the CAE® were conducted at Day 1, Day 15, Day 29 and Day 57.
|
0.25% HL036 Ophthalmic Solution
n=318 Participants
Participants self-administered HL036 0.25 % ophthalmic solution as topical ophthalmic drops BID for up to 8 weeks. Exposures to the CAE® were conducted at Day 1, Day 15, Day 29 and Day 57.
|
|---|---|---|
|
Change From Baseline in Visual Analog Scale (Pain)
Change from baseline: Day 57 (Change from Pre-CAE to Post-CAE)
|
-0.8 mm
Standard Deviation 26.50
|
-1.8 mm
Standard Deviation 25.64
|
|
Change From Baseline in Visual Analog Scale (Pain)
Change from Baseline: Day 8
|
-2.9 mm
Standard Deviation 19.27
|
-3.7 mm
Standard Deviation 17.44
|
|
Change From Baseline in Visual Analog Scale (Pain)
Change from Baseline: Day 15 (Pre-CAE)
|
-4.0 mm
Standard Deviation 19.52
|
-3.5 mm
Standard Deviation 20.36
|
|
Change From Baseline in Visual Analog Scale (Pain)
Day 1 Pre-CAE
|
26.2 mm
Standard Deviation 25.34
|
27.7 mm
Standard Deviation 26.43
|
|
Change From Baseline in Visual Analog Scale (Pain)
Day 1 Post-CAE
|
37.0 mm
Standard Deviation 29.17
|
39.3 mm
Standard Deviation 31.31
|
|
Change From Baseline in Visual Analog Scale (Pain)
Day 1 (Change from Pre-CAE to Post-CAE)
|
10.8 mm
Standard Deviation 21.13
|
11.6 mm
Standard Deviation 22.26
|
|
Change From Baseline in Visual Analog Scale (Pain)
Change from Baseline: Day 15 (Post-CAE)
|
-5.8 mm
Standard Deviation 21.95
|
-5.2 mm
Standard Deviation 23.17
|
|
Change From Baseline in Visual Analog Scale (Pain)
Change from baseline: Day 15 (Change from Pre-CAE to Post-CAE)
|
-1.9 mm
Standard Deviation 21.55
|
-1.3 mm
Standard Deviation 24.59
|
|
Change From Baseline in Visual Analog Scale (Pain)
Change from Baseline: Day 29 (Pre-CAE)
|
-5.4 mm
Standard Deviation 20.52
|
-5.7 mm
Standard Deviation 22.52
|
|
Change From Baseline in Visual Analog Scale (Pain)
Change from Baseline: Day 29 (Post-CAE)
|
-9.0 mm
Standard Deviation 23.24
|
-6.3 mm
Standard Deviation 22.39
|
|
Change From Baseline in Visual Analog Scale (Pain)
Change from baseline: Day 29 (Change from Pre-CAE to Post-CAE)
|
-3.6 mm
Standard Deviation 23.73
|
-0.6 mm
Standard Deviation 24.88
|
|
Change From Baseline in Visual Analog Scale (Pain)
Change from Baseline: Day 57 (Pre-CAE)
|
-7.3 mm
Standard Deviation 22.61
|
-5.3 mm
Standard Deviation 21.66
|
|
Change From Baseline in Visual Analog Scale (Pain)
Change from Baseline: Day 57 (Post-CAE)
|
-8.3 mm
Standard Deviation 25.19
|
-7.7 mm
Standard Deviation 25.24
|
SECONDARY outcome
Timeframe: Baseline (Day 1 Pre-CAE and Post-CAE), Day 8, Day 15 (Pre-CAE and Post-CAE), Day 29 (Pre-CAE and Post-CAE), and Day 57 (Pre-CAE and Post-CAE)Population: Number of participants analyzed included participants in ITT Population with available data. The analysis was carried out with observed data only.
It was assessed by the Ora Calibra® ocular discomfort scale. The score ranges from 0 to 4 (0=none and 4=severe), where lower score indicates improvement.
Outcome measures
| Measure |
Placebo
n=319 Participants
Participants self-administered HL036 placebo (vehicle solution) as topical ophthalmic drops, BID for up to 8 weeks. Exposures to the CAE® were conducted at Day 1, Day 15, Day 29 and Day 57.
|
0.25% HL036 Ophthalmic Solution
n=318 Participants
Participants self-administered HL036 0.25 % ophthalmic solution as topical ophthalmic drops BID for up to 8 weeks. Exposures to the CAE® were conducted at Day 1, Day 15, Day 29 and Day 57.
|
|---|---|---|
|
Change From Baseline in Ocular Discomfort Scale
Day 1 Pre-CAE
|
2.5 mm
Standard Deviation 1.06
|
2.6 mm
Standard Deviation 0.98
|
|
Change From Baseline in Ocular Discomfort Scale
Day 1 (Change from Pre-CAE to Post-CAE)
|
1.1 mm
Standard Deviation 1.12
|
1.0 mm
Standard Deviation 1.07
|
|
Change From Baseline in Ocular Discomfort Scale
Change from Baseline: Day 8
|
-0.2 mm
Standard Deviation 1.11
|
-0.3 mm
Standard Deviation 1.20
|
|
Change From Baseline in Ocular Discomfort Scale
Change from Baseline: Day 15 (Pre-CAE)
|
-0.3 mm
Standard Deviation 1.18
|
-0.5 mm
Standard Deviation 1.18
|
|
Change From Baseline in Ocular Discomfort Scale
Change from Baseline: Day 15 (Post-CAE)
|
-0.1 mm
Standard Deviation 0.74
|
-0.2 mm
Standard Deviation 0.77
|
|
Change From Baseline in Ocular Discomfort Scale
Change from baseline: Day 15 (Change from Pre-CAE to Post-CAE)
|
0.1 mm
Standard Deviation 1.36
|
0.3 mm
Standard Deviation 1.32
|
|
Change From Baseline in Ocular Discomfort Scale
Change from Baseline: Day 29 (Pre-CAE)
|
-0.2 mm
Standard Deviation 1.23
|
-0.4 mm
Standard Deviation 1.30
|
|
Change From Baseline in Ocular Discomfort Scale
Change from Baseline: Day 29 (Post-CAE)
|
-0.2 mm
Standard Deviation 0.84
|
-0.2 mm
Standard Deviation 0.73
|
|
Change From Baseline in Ocular Discomfort Scale
Change from baseline: Day 29 (Change from Pre-CAE to Post-CAE)
|
0.0 mm
Standard Deviation 1.38
|
0.2 mm
Standard Deviation 1.44
|
|
Change From Baseline in Ocular Discomfort Scale
Change from Baseline: Day 57 (Pre-CAE)
|
-0.5 mm
Standard Deviation 1.24
|
-0.5 mm
Standard Deviation 1.29
|
|
Change From Baseline in Ocular Discomfort Scale
Change from Baseline: Day 57 (Post-CAE)
|
-0.3 mm
Standard Deviation 0.95
|
-0.4 mm
Standard Deviation 0.91
|
|
Change From Baseline in Ocular Discomfort Scale
Change from baseline: Day 57 (Change from Pre-CAE to Post-CAE)
|
0.2 mm
Standard Deviation 1.37
|
0.1 mm
Standard Deviation 1.41
|
|
Change From Baseline in Ocular Discomfort Scale
Day 1 Post-CAE
|
3.6 mm
Standard Deviation 0.64
|
3.6 mm
Standard Deviation 0.59
|
SECONDARY outcome
Timeframe: Baseline (Day 1 Pre-CAE and Post-CAE), Day 8, Day 15 (Pre-CAE and Post-CAE), Day 29 (Pre-CAE and Post-CAE), and Day 57 (Pre-CAE and Post-CAE)Population: Number of participants analyzed included participants in ITT Population with available data. The analysis was carried out with observed data only.
Ora Calibra® ocular discomfort \& 4-symptom questionnaire for dry eye includes rating of the severity of 5 symptoms: ocular discomfort, burning, dryness, grittiness, and stinging. At each day during the at-home dosing period, subjects will grade the severity of their dry eye syndrome symptoms in the morning and in the evening, before instilling the study drug. Participants rated the severity of overall ocular discomfort on 0 to 5 scale, where 0=none and 5=severe.
Outcome measures
| Measure |
Placebo
n=319 Participants
Participants self-administered HL036 placebo (vehicle solution) as topical ophthalmic drops, BID for up to 8 weeks. Exposures to the CAE® were conducted at Day 1, Day 15, Day 29 and Day 57.
|
0.25% HL036 Ophthalmic Solution
n=318 Participants
Participants self-administered HL036 0.25 % ophthalmic solution as topical ophthalmic drops BID for up to 8 weeks. Exposures to the CAE® were conducted at Day 1, Day 15, Day 29 and Day 57.
|
|---|---|---|
|
Change From Baseline in Ora Calibra® Ocular Discomfort & 4-Symptom Questionnaire for Dry Eye (Overall Ocular Discomfort)
Day 1 Pre-CAE
|
2.8 mm
Standard Deviation 1.00
|
2.8 mm
Standard Deviation 0.94
|
|
Change From Baseline in Ora Calibra® Ocular Discomfort & 4-Symptom Questionnaire for Dry Eye (Overall Ocular Discomfort)
Day 1 Post-CAE
|
3.7 mm
Standard Deviation 0.79
|
3.7 mm
Standard Deviation 0.82
|
|
Change From Baseline in Ora Calibra® Ocular Discomfort & 4-Symptom Questionnaire for Dry Eye (Overall Ocular Discomfort)
Day 1 (Change from Pre-CAE to Post-CAE)
|
0.9 mm
Standard Deviation 0.98
|
0.9 mm
Standard Deviation 0.98
|
|
Change From Baseline in Ora Calibra® Ocular Discomfort & 4-Symptom Questionnaire for Dry Eye (Overall Ocular Discomfort)
Change from Baseline: Day 8
|
-0.2 mm
Standard Deviation 1.03
|
-0.2 mm
Standard Deviation 1.05
|
|
Change From Baseline in Ora Calibra® Ocular Discomfort & 4-Symptom Questionnaire for Dry Eye (Overall Ocular Discomfort)
Change from Baseline: Day 15 (Pre-CAE)
|
-0.3 mm
Standard Deviation 0.99
|
-0.4 mm
Standard Deviation 1.09
|
|
Change From Baseline in Ora Calibra® Ocular Discomfort & 4-Symptom Questionnaire for Dry Eye (Overall Ocular Discomfort)
Change from Baseline: Day 15 (Post-CAE)
|
-0.3 mm
Standard Deviation 0.82
|
-0.2 mm
Standard Deviation 0.95
|
|
Change From Baseline in Ora Calibra® Ocular Discomfort & 4-Symptom Questionnaire for Dry Eye (Overall Ocular Discomfort)
Change from baseline: Day 15 (Change from Pre-CAE to Post-CAE)
|
0.1 mm
Standard Deviation 1.17
|
0.2 mm
Standard Deviation 1.35
|
|
Change From Baseline in Ora Calibra® Ocular Discomfort & 4-Symptom Questionnaire for Dry Eye (Overall Ocular Discomfort)
Change from Baseline: Day 29 (Pre-CAE)
|
-0.3 mm
Standard Deviation 1.20
|
-0.4 mm
Standard Deviation 1.14
|
|
Change From Baseline in Ora Calibra® Ocular Discomfort & 4-Symptom Questionnaire for Dry Eye (Overall Ocular Discomfort)
Change from Baseline: Day 29 (Post-CAE)
|
-0.3 mm
Standard Deviation 0.89
|
-0.3 mm
Standard Deviation 0.86
|
|
Change From Baseline in Ora Calibra® Ocular Discomfort & 4-Symptom Questionnaire for Dry Eye (Overall Ocular Discomfort)
Change from baseline: Day 29 (Change from Pre-CAE to Post-CAE)
|
0.0 mm
Standard Deviation 1.40
|
0.1 mm
Standard Deviation 1.29
|
|
Change From Baseline in Ora Calibra® Ocular Discomfort & 4-Symptom Questionnaire for Dry Eye (Overall Ocular Discomfort)
Change from Baseline: Day 57 (Pre-CAE)
|
-0.5 mm
Standard Deviation 1.14
|
-0.4 mm
Standard Deviation 1.21
|
|
Change From Baseline in Ora Calibra® Ocular Discomfort & 4-Symptom Questionnaire for Dry Eye (Overall Ocular Discomfort)
Change from Baseline: Day 57 (Post-CAE)
|
-0.4 mm
Standard Deviation 1.04
|
-0.4 mm
Standard Deviation 1.01
|
|
Change From Baseline in Ora Calibra® Ocular Discomfort & 4-Symptom Questionnaire for Dry Eye (Overall Ocular Discomfort)
Change from baseline: Day 57 (Change from Pre-CAE to Post-CAE)
|
0.1 mm
Standard Deviation 1.21
|
0.1 mm
Standard Deviation 1.31
|
SECONDARY outcome
Timeframe: Baseline (Day 1 Pre-CAE and Post-CAE), Day 8, Day 15 (Pre-CAE and Post-CAE), Day 29 (Pre-CAE and Post-CAE), and Day 57 (Pre-CAE and Post-CAE)Population: Number of participants analyzed included participants in ITT Population with available data. The analysis was carried out with observed data only.
Ora Calibra® ocular discomfort \& 4-symptom questionnaire for dry eye includes rating of the severity of 5 symptoms: ocular discomfort, burning, dryness, grittiness, and stinging. At each day during the at-home dosing period, subjects graded the severity of their dry eye syndrome symptoms in the morning and in the evening, before instilling the study drug. Participants rated the severity of burning on 0 to 5 scale, where 0=none and 5=severe.
Outcome measures
| Measure |
Placebo
n=319 Participants
Participants self-administered HL036 placebo (vehicle solution) as topical ophthalmic drops, BID for up to 8 weeks. Exposures to the CAE® were conducted at Day 1, Day 15, Day 29 and Day 57.
|
0.25% HL036 Ophthalmic Solution
n=318 Participants
Participants self-administered HL036 0.25 % ophthalmic solution as topical ophthalmic drops BID for up to 8 weeks. Exposures to the CAE® were conducted at Day 1, Day 15, Day 29 and Day 57.
|
|---|---|---|
|
Change From Baseline in Ora Calibra® Ocular Discomfort & 4-Symptom Questionnaire for Dry Eye (Burning)
Day 1 Pre-CAE
|
1.7 mm
Standard Deviation 1.38
|
1.7 mm
Standard Deviation 1.43
|
|
Change From Baseline in Ora Calibra® Ocular Discomfort & 4-Symptom Questionnaire for Dry Eye (Burning)
Day 1 Post-CAE
|
2.6 mm
Standard Deviation 1.56
|
2.6 mm
Standard Deviation 1.56
|
|
Change From Baseline in Ora Calibra® Ocular Discomfort & 4-Symptom Questionnaire for Dry Eye (Burning)
Day 1 (Change from Pre-CAE to Post-CAE)
|
0.9 mm
Standard Deviation 1.22
|
0.9 mm
Standard Deviation 1.34
|
|
Change From Baseline in Ora Calibra® Ocular Discomfort & 4-Symptom Questionnaire for Dry Eye (Burning)
Change from Baseline: Day 8
|
-0.2 mm
Standard Deviation 1.08
|
-0.1 mm
Standard Deviation 1.14
|
|
Change From Baseline in Ora Calibra® Ocular Discomfort & 4-Symptom Questionnaire for Dry Eye (Burning)
Change from Baseline: Day 15 (Pre-CAE)
|
-0.2 mm
Standard Deviation 1.15
|
-0.2 mm
Standard Deviation 1.18
|
|
Change From Baseline in Ora Calibra® Ocular Discomfort & 4-Symptom Questionnaire for Dry Eye (Burning)
Change from Baseline: Day 15 (Post-CAE)
|
-0.3 mm
Standard Deviation 1.20
|
-0.3 mm
Standard Deviation 1.18
|
|
Change From Baseline in Ora Calibra® Ocular Discomfort & 4-Symptom Questionnaire for Dry Eye (Burning)
Change from baseline: Day 15 (Change from Pre-CAE to Post-CAE)
|
-0.1 mm
Standard Deviation 1.43
|
-0.1 mm
Standard Deviation 1.50
|
|
Change From Baseline in Ora Calibra® Ocular Discomfort & 4-Symptom Questionnaire for Dry Eye (Burning)
Change from Baseline: Day 29 (Pre-CAE)
|
-0.2 mm
Standard Deviation 1.16
|
-0.3 mm
Standard Deviation 1.18
|
|
Change From Baseline in Ora Calibra® Ocular Discomfort & 4-Symptom Questionnaire for Dry Eye (Burning)
Change from Baseline: Day 29 (Post-CAE)
|
-0.3 mm
Standard Deviation 1.25
|
-0.3 mm
Standard Deviation 1.26
|
|
Change From Baseline in Ora Calibra® Ocular Discomfort & 4-Symptom Questionnaire for Dry Eye (Burning)
Change from baseline: Day 29 (Change from Pre-CAE to Post-CAE)
|
-0.2 mm
Standard Deviation 1.55
|
-0.1 mm
Standard Deviation 1.57
|
|
Change From Baseline in Ora Calibra® Ocular Discomfort & 4-Symptom Questionnaire for Dry Eye (Burning)
Change from Baseline: Day 57 (Pre-CAE)
|
-0.4 mm
Standard Deviation 1.25
|
-0.3 mm
Standard Deviation 1.19
|
|
Change From Baseline in Ora Calibra® Ocular Discomfort & 4-Symptom Questionnaire for Dry Eye (Burning)
Change from Baseline: Day 57 (Post-CAE)
|
-0.4 mm
Standard Deviation 1.36
|
-0.3 mm
Standard Deviation 1.37
|
|
Change From Baseline in Ora Calibra® Ocular Discomfort & 4-Symptom Questionnaire for Dry Eye (Burning)
Change from baseline: Day 57 (Change from Pre-CAE to Post-CAE)
|
0.0 mm
Standard Deviation 1.61
|
0.0 mm
Standard Deviation 1.49
|
SECONDARY outcome
Timeframe: Baseline (Day 1 Pre-CAE and Post-CAE), Day 8, Day 15 (Pre-CAE and Post-CAE), Day 29 (Pre-CAE and Post-CAE), and Day 57 (Pre-CAE and Post-CAE)Population: Number of participants analyzed included participants in ITT Population with available data. The analysis was carried out with observed data only.
Ora Calibra® ocular discomfort \& 4-symptom questionnaire for dry eye includes rating of the severity of 5 symptoms: ocular discomfort, burning, dryness, grittiness, and stinging. At each day during the at-home dosing period, subjects graded the severity of their dry eye syndrome symptoms in the morning and in the evening, before instilling the study drug. Participants rated the severity of dryness on 0 to 5 scale, where 0=none and 5=severe.
Outcome measures
| Measure |
Placebo
n=319 Participants
Participants self-administered HL036 placebo (vehicle solution) as topical ophthalmic drops, BID for up to 8 weeks. Exposures to the CAE® were conducted at Day 1, Day 15, Day 29 and Day 57.
|
0.25% HL036 Ophthalmic Solution
n=318 Participants
Participants self-administered HL036 0.25 % ophthalmic solution as topical ophthalmic drops BID for up to 8 weeks. Exposures to the CAE® were conducted at Day 1, Day 15, Day 29 and Day 57.
|
|---|---|---|
|
Change From Baseline in Ora Calibra® Ocular Discomfort & 4-Symptom Questionnaire for Dry Eye (Dryness)
Day 1 Pre-CAE
|
3.2 mm
Standard Deviation 0.97
|
3.2 mm
Standard Deviation 1.05
|
|
Change From Baseline in Ora Calibra® Ocular Discomfort & 4-Symptom Questionnaire for Dry Eye (Dryness)
Day 1 Post-CAE
|
3.9 mm
Standard Deviation 0.88
|
3.9 mm
Standard Deviation 0.89
|
|
Change From Baseline in Ora Calibra® Ocular Discomfort & 4-Symptom Questionnaire for Dry Eye (Dryness)
Day 1 (Change from Pre-CAE to Post-CAE)
|
0.8 mm
Standard Deviation 0.95
|
0.8 mm
Standard Deviation 0.97
|
|
Change From Baseline in Ora Calibra® Ocular Discomfort & 4-Symptom Questionnaire for Dry Eye (Dryness)
Change from Baseline: Day 8
|
-0.3 mm
Standard Deviation 1.05
|
-0.2 mm
Standard Deviation 0.98
|
|
Change From Baseline in Ora Calibra® Ocular Discomfort & 4-Symptom Questionnaire for Dry Eye (Dryness)
Change from Baseline: Day 15 (Pre-CAE)
|
-0.4 mm
Standard Deviation 0.99
|
-0.4 mm
Standard Deviation 1.01
|
|
Change From Baseline in Ora Calibra® Ocular Discomfort & 4-Symptom Questionnaire for Dry Eye (Dryness)
Change from Baseline: Day 15 (Post-CAE)
|
-0.2 mm
Standard Deviation 0.78
|
-0.2 mm
Standard Deviation 0.85
|
|
Change From Baseline in Ora Calibra® Ocular Discomfort & 4-Symptom Questionnaire for Dry Eye (Dryness)
Change from baseline: Day 15 (Change from Pre-CAE to Post-CAE)
|
0.1 mm
Standard Deviation 1.11
|
0.1 mm
Standard Deviation 1.20
|
|
Change From Baseline in Ora Calibra® Ocular Discomfort & 4-Symptom Questionnaire for Dry Eye (Dryness)
Change from Baseline: Day 29 (Pre-CAE)
|
-0.4 mm
Standard Deviation 1.22
|
-0.4 mm
Standard Deviation 1.16
|
|
Change From Baseline in Ora Calibra® Ocular Discomfort & 4-Symptom Questionnaire for Dry Eye (Dryness)
Change from Baseline: Day 29 (Post-CAE)
|
-0.3 mm
Standard Deviation 0.92
|
-0.2 mm
Standard Deviation 0.91
|
|
Change From Baseline in Ora Calibra® Ocular Discomfort & 4-Symptom Questionnaire for Dry Eye (Dryness)
Change from baseline: Day 29 (Change from Pre-CAE to Post-CAE)
|
0.1 mm
Standard Deviation 1.38
|
0.2 mm
Standard Deviation 1.22
|
|
Change From Baseline in Ora Calibra® Ocular Discomfort & 4-Symptom Questionnaire for Dry Eye (Dryness)
Change from Baseline: Day 57 (Pre-CAE)
|
-0.6 mm
Standard Deviation 1.18
|
-0.5 mm
Standard Deviation 1.22
|
|
Change From Baseline in Ora Calibra® Ocular Discomfort & 4-Symptom Questionnaire for Dry Eye (Dryness)
Change from Baseline: Day 57 (Post-CAE)
|
-0.5 mm
Standard Deviation 1.10
|
-0.4 mm
Standard Deviation 1.12
|
|
Change From Baseline in Ora Calibra® Ocular Discomfort & 4-Symptom Questionnaire for Dry Eye (Dryness)
Change from baseline: Day 57 (Change from Pre-CAE to Post-CAE)
|
0.1 mm
Standard Deviation 1.34
|
0.1 mm
Standard Deviation 1.34
|
SECONDARY outcome
Timeframe: Baseline (Day 1 Pre-CAE and Post-CAE), Day 8, Day 15 (Pre-CAE and Post-CAE), Day 29 (Pre-CAE and Post-CAE), and Day 57 (Pre-CAE and Post-CAE)Population: Number of participants analyzed included participants in ITT Population with available data. The analysis was carried out with observed data only.
Ora Calibra® ocular discomfort \& 4-symptom questionnaire for dry eye includes rating of the severity of 5 symptoms: ocular discomfort, burning, dryness, grittiness, and stinging. At each day during the at-home dosing period, subjects graded the severity of their dry eye syndrome symptoms in the morning and in the evening, before instilling the study drug. Participants rated the severity of grittiness on 0 to 5 scale, where 0=none and 5=severe.
Outcome measures
| Measure |
Placebo
n=319 Participants
Participants self-administered HL036 placebo (vehicle solution) as topical ophthalmic drops, BID for up to 8 weeks. Exposures to the CAE® were conducted at Day 1, Day 15, Day 29 and Day 57.
|
0.25% HL036 Ophthalmic Solution
n=318 Participants
Participants self-administered HL036 0.25 % ophthalmic solution as topical ophthalmic drops BID for up to 8 weeks. Exposures to the CAE® were conducted at Day 1, Day 15, Day 29 and Day 57.
|
|---|---|---|
|
Change From Baseline in Ora Calibra® Ocular Discomfort & 4-Symptom Questionnaire for Dry Eye (Grittiness)
Day 1 Pre-CAE
|
2.1 mm
Standard Deviation 1.43
|
2.1 mm
Standard Deviation 1.42
|
|
Change From Baseline in Ora Calibra® Ocular Discomfort & 4-Symptom Questionnaire for Dry Eye (Grittiness)
Day 1 Post-CAE
|
2.6 mm
Standard Deviation 1.55
|
2.7 mm
Standard Deviation 1.49
|
|
Change From Baseline in Ora Calibra® Ocular Discomfort & 4-Symptom Questionnaire for Dry Eye (Grittiness)
Day 1 (Change from Pre-CAE to Post-CAE)
|
0.5 mm
Standard Deviation 1.16
|
0.6 mm
Standard Deviation 1.14
|
|
Change From Baseline in Ora Calibra® Ocular Discomfort & 4-Symptom Questionnaire for Dry Eye (Grittiness)
Change from Baseline: Day 8
|
-0.2 mm
Standard Deviation 1.17
|
-0.3 mm
Standard Deviation 1.05
|
|
Change From Baseline in Ora Calibra® Ocular Discomfort & 4-Symptom Questionnaire for Dry Eye (Grittiness)
Change from Baseline: Day 15 (Pre-CAE)
|
-0.3 mm
Standard Deviation 1.07
|
-0.3 mm
Standard Deviation 1.12
|
|
Change From Baseline in Ora Calibra® Ocular Discomfort & 4-Symptom Questionnaire for Dry Eye (Grittiness)
Change from Baseline: Day 15 (Post-CAE)
|
-0.2 mm
Standard Deviation 1.06
|
-0.3 mm
Standard Deviation 1.20
|
|
Change From Baseline in Ora Calibra® Ocular Discomfort & 4-Symptom Questionnaire for Dry Eye (Grittiness)
Change from baseline: Day 15 (Change from Pre-CAE to Post-CAE)
|
0.1 mm
Standard Deviation 1.31
|
0.0 mm
Standard Deviation 1.43
|
|
Change From Baseline in Ora Calibra® Ocular Discomfort & 4-Symptom Questionnaire for Dry Eye (Grittiness)
Change from Baseline: Day 29 (Pre-CAE)
|
-0.3 mm
Standard Deviation 1.15
|
-0.4 mm
Standard Deviation 1.14
|
|
Change From Baseline in Ora Calibra® Ocular Discomfort & 4-Symptom Questionnaire for Dry Eye (Grittiness)
Change from Baseline: Day 29 (Post-CAE)
|
-0.3 mm
Standard Deviation 1.19
|
-0.3 mm
Standard Deviation 1.20
|
|
Change From Baseline in Ora Calibra® Ocular Discomfort & 4-Symptom Questionnaire for Dry Eye (Grittiness)
Change from Baseline: Day 57 (Pre-CAE)
|
-0.4 mm
Standard Deviation 1.20
|
-0.4 mm
Standard Deviation 1.15
|
|
Change From Baseline in Ora Calibra® Ocular Discomfort & 4-Symptom Questionnaire for Dry Eye (Grittiness)
Change from baseline: Day 57 (Change from Pre-CAE to Post-CAE)
|
0.1 mm
Standard Deviation 1.46
|
0.1 mm
Standard Deviation 1.37
|
|
Change From Baseline in Ora Calibra® Ocular Discomfort & 4-Symptom Questionnaire for Dry Eye (Grittiness)
Change from baseline: Day 29 (Change from Pre-CAE to Post-CAE)
|
0.0 mm
Standard Deviation 1.37
|
0.1 mm
Standard Deviation 1.40
|
|
Change From Baseline in Ora Calibra® Ocular Discomfort & 4-Symptom Questionnaire for Dry Eye (Grittiness)
Change from Baseline: Day 57 (Post-CAE)
|
-0.3 mm
Standard Deviation 1.32
|
-0.4 mm
Standard Deviation 1.29
|
SECONDARY outcome
Timeframe: Baseline (Day 1 Pre-CAE and Post-CAE), Day 8, Day 15 (Pre-CAE and Post-CAE), Day 29 (Pre-CAE and Post-CAE), and Day 57 (Pre-CAE and Post-CAE)Population: Number of participants analyzed included participants in ITT Population with available data. The analysis was carried out with observed data only.
Ora Calibra® ocular discomfort \& 4-symptom questionnaire for dry eye includes rating of the severity of 5 symptoms: ocular discomfort, burning, dryness, grittiness, and stinging. At each day during the at-home dosing period, subjects graded the severity of their dry eye syndrome symptoms in the morning and in the evening, before instilling the study drug. Participants rated the severity of stinging on 0 to 5 scale, where 0=none and 5=severe.
Outcome measures
| Measure |
Placebo
n=319 Participants
Participants self-administered HL036 placebo (vehicle solution) as topical ophthalmic drops, BID for up to 8 weeks. Exposures to the CAE® were conducted at Day 1, Day 15, Day 29 and Day 57.
|
0.25% HL036 Ophthalmic Solution
n=318 Participants
Participants self-administered HL036 0.25 % ophthalmic solution as topical ophthalmic drops BID for up to 8 weeks. Exposures to the CAE® were conducted at Day 1, Day 15, Day 29 and Day 57.
|
|---|---|---|
|
Change From Baseline in Ora Calibra® Ocular Discomfort & 4-Symptom Questionnaire for Dry Eye (Stinging)
Day 1 Pre-CAE
|
1.6 mm
Standard Deviation 1.32
|
1.6 mm
Standard Deviation 1.42
|
|
Change From Baseline in Ora Calibra® Ocular Discomfort & 4-Symptom Questionnaire for Dry Eye (Stinging)
Day 1 Post-CAE
|
2.4 mm
Standard Deviation 1.52
|
2.3 mm
Standard Deviation 1.55
|
|
Change From Baseline in Ora Calibra® Ocular Discomfort & 4-Symptom Questionnaire for Dry Eye (Stinging)
Day 1 (Change from Pre-CAE to Post-CAE)
|
0.8 mm
Standard Deviation 1.11
|
0.8 mm
Standard Deviation 1.10
|
|
Change From Baseline in Ora Calibra® Ocular Discomfort & 4-Symptom Questionnaire for Dry Eye (Stinging)
Change from Baseline: Day 8
|
-0.1 mm
Standard Deviation 1.03
|
-0.1 mm
Standard Deviation 1.00
|
|
Change From Baseline in Ora Calibra® Ocular Discomfort & 4-Symptom Questionnaire for Dry Eye (Stinging)
Change from Baseline: Day 15 (Post-CAE)
|
-0.3 mm
Standard Deviation 1.17
|
-0.3 mm
Standard Deviation 1.15
|
|
Change From Baseline in Ora Calibra® Ocular Discomfort & 4-Symptom Questionnaire for Dry Eye (Stinging)
Change from baseline: Day 15 (Change from Pre-CAE to Post-CAE)
|
0.0 mm
Standard Deviation 1.32
|
-0.1 mm
Standard Deviation 1.41
|
|
Change From Baseline in Ora Calibra® Ocular Discomfort & 4-Symptom Questionnaire for Dry Eye (Stinging)
Change from Baseline: Day 29 (Pre-CAE)
|
-0.3 mm
Standard Deviation 1.05
|
-0.3 mm
Standard Deviation 1.16
|
|
Change From Baseline in Ora Calibra® Ocular Discomfort & 4-Symptom Questionnaire for Dry Eye (Stinging)
Change from Baseline: Day 29 (Post-CAE)
|
-0.5 mm
Standard Deviation 1.26
|
-0.3 mm
Standard Deviation 1.30
|
|
Change From Baseline in Ora Calibra® Ocular Discomfort & 4-Symptom Questionnaire for Dry Eye (Stinging)
Change from baseline: Day 29 (Change from Pre-CAE to Post-CAE)
|
-0.2 mm
Standard Deviation 1.38
|
0.0 mm
Standard Deviation 1.48
|
|
Change From Baseline in Ora Calibra® Ocular Discomfort & 4-Symptom Questionnaire for Dry Eye (Stinging)
Change from Baseline: Day 57 (Pre-CAE)
|
-0.4 mm
Standard Deviation 1.09
|
-0.4 mm
Standard Deviation 1.23
|
|
Change From Baseline in Ora Calibra® Ocular Discomfort & 4-Symptom Questionnaire for Dry Eye (Stinging)
Change from Baseline: Day 57 (Post-CAE)
|
-0.5 mm
Standard Deviation 1.31
|
-0.3 mm
Standard Deviation 1.24
|
|
Change From Baseline in Ora Calibra® Ocular Discomfort & 4-Symptom Questionnaire for Dry Eye (Stinging)
Change from baseline: Day 57 (Change from Pre-CAE to Post-CAE)
|
0.0 mm
Standard Deviation 1.43
|
0.1 mm
Standard Deviation 1.38
|
|
Change From Baseline in Ora Calibra® Ocular Discomfort & 4-Symptom Questionnaire for Dry Eye (Stinging)
Change from Baseline: Day 15 (Pre-CAE)
|
-0.3 mm
Standard Deviation 1.01
|
-0.2 mm
Standard Deviation 1.07
|
SECONDARY outcome
Timeframe: Upon instillation and 1 and 2 minutes post-instillation on Day 1Population: The ITT Population with available data. The analysis was carried out with observed data only.
Ora Calibra® drop comfort scale ranges from 0 to 10. A score of 0 indicates comfortable and 10 indicates uncomfortable. Lower score indicated better comfort level.
Outcome measures
| Measure |
Placebo
n=319 Participants
Participants self-administered HL036 placebo (vehicle solution) as topical ophthalmic drops, BID for up to 8 weeks. Exposures to the CAE® were conducted at Day 1, Day 15, Day 29 and Day 57.
|
0.25% HL036 Ophthalmic Solution
n=318 Participants
Participants self-administered HL036 0.25 % ophthalmic solution as topical ophthalmic drops BID for up to 8 weeks. Exposures to the CAE® were conducted at Day 1, Day 15, Day 29 and Day 57.
|
|---|---|---|
|
Ora Calibra® Drop Comfort Scale
Upon instillation on Day 1
|
3.5 score on a scale
Standard Deviation 2.79
|
3.5 score on a scale
Standard Deviation 2.75
|
|
Ora Calibra® Drop Comfort Scale
1 minute post-instillation on Day 1
|
2.5 score on a scale
Standard Deviation 2.12
|
2.5 score on a scale
Standard Deviation 2.32
|
|
Ora Calibra® Drop Comfort Scale
2 minutes post-instillation on Day 1
|
2.0 score on a scale
Standard Deviation 2.02
|
2.1 score on a scale
Standard Deviation 2.19
|
SECONDARY outcome
Timeframe: From Day -14 to Day 56Population: Number of participants analyzed included participants in ITT Population with available data. The analysis was carried out with observed data only.
Ora Calibra® ocular discomfort \& 4-symptom questionnaire for dry eye includes rating of the severity of 5 symptoms: ocular discomfort, burning, dryness, grittiness, and stinging. Participants rated the severity of overall ocular discomfort twice a day in a diary on 0 to 5 scale, where 0=none and 5=severe. Higher score represent higher severity. The average of the morning and evening assessments were calculated for each day. Weekly average scores were calculated based on the daily scores in the week.
Outcome measures
| Measure |
Placebo
n=311 Participants
Participants self-administered HL036 placebo (vehicle solution) as topical ophthalmic drops, BID for up to 8 weeks. Exposures to the CAE® were conducted at Day 1, Day 15, Day 29 and Day 57.
|
0.25% HL036 Ophthalmic Solution
n=310 Participants
Participants self-administered HL036 0.25 % ophthalmic solution as topical ophthalmic drops BID for up to 8 weeks. Exposures to the CAE® were conducted at Day 1, Day 15, Day 29 and Day 57.
|
|---|---|---|
|
Daily Diary: Change From Baseline in Ora Calibra® Ocular Discomfort & 4-Symptom Questionnaire for Dry Eye (Overall Ocular Discomfort)
Day -14 - Day -1 (Baseline) Daily Average
|
2.7 score on a scale
Standard Deviation 1.02
|
2.7 score on a scale
Standard Deviation 0.96
|
|
Daily Diary: Change From Baseline in Ora Calibra® Ocular Discomfort & 4-Symptom Questionnaire for Dry Eye (Overall Ocular Discomfort)
Day 1 - Day 7, Daily Average Change from Baseline
|
-0.1 score on a scale
Standard Deviation 0.52
|
-0.1 score on a scale
Standard Deviation 0.49
|
|
Daily Diary: Change From Baseline in Ora Calibra® Ocular Discomfort & 4-Symptom Questionnaire for Dry Eye (Overall Ocular Discomfort)
Day 8 - Day 14, Daily Average Change from Baseline
|
-0.1 score on a scale
Standard Deviation 0.58
|
-0.2 score on a scale
Standard Deviation 0.56
|
|
Daily Diary: Change From Baseline in Ora Calibra® Ocular Discomfort & 4-Symptom Questionnaire for Dry Eye (Overall Ocular Discomfort)
Day 15 - Day 21, Daily Average Change from Baseline
|
-0.2 score on a scale
Standard Deviation 0.70
|
-0.2 score on a scale
Standard Deviation 0.66
|
|
Daily Diary: Change From Baseline in Ora Calibra® Ocular Discomfort & 4-Symptom Questionnaire for Dry Eye (Overall Ocular Discomfort)
Day 22 - Day 28, Daily Average Change from Baseline
|
-0.3 score on a scale
Standard Deviation 0.79
|
-0.3 score on a scale
Standard Deviation 0.71
|
|
Daily Diary: Change From Baseline in Ora Calibra® Ocular Discomfort & 4-Symptom Questionnaire for Dry Eye (Overall Ocular Discomfort)
Day 29 - Day 35, Daily Average Change from Baseline
|
-0.2 score on a scale
Standard Deviation 0.80
|
-0.3 score on a scale
Standard Deviation 0.76
|
|
Daily Diary: Change From Baseline in Ora Calibra® Ocular Discomfort & 4-Symptom Questionnaire for Dry Eye (Overall Ocular Discomfort)
Day 36 - Day 42, Daily Average Change from Baseline
|
-0.3 score on a scale
Standard Deviation 0.85
|
-0.3 score on a scale
Standard Deviation 0.77
|
|
Daily Diary: Change From Baseline in Ora Calibra® Ocular Discomfort & 4-Symptom Questionnaire for Dry Eye (Overall Ocular Discomfort)
Day 43 - Day 49, Daily Average Change from Baseline
|
-0.4 score on a scale
Standard Deviation 0.89
|
-0.3 score on a scale
Standard Deviation 0.83
|
|
Daily Diary: Change From Baseline in Ora Calibra® Ocular Discomfort & 4-Symptom Questionnaire for Dry Eye (Overall Ocular Discomfort)
Day 50 - Day 56, Daily Average Change from Baseline
|
-0.4 score on a scale
Standard Deviation 0.93
|
-0.3 score on a scale
Standard Deviation 0.83
|
SECONDARY outcome
Timeframe: From Day -14 to Day 56Population: Number of participants analyzed included participants in ITT Population with available data. The analysis was carried out with observed data only.
Ora Calibra® ocular discomfort \& 4-symptom questionnaire for dry eye includes rating of the severity of 5 symptoms: ocular discomfort, burning, dryness, grittiness, and stinging. Participants rated the severity of burning twice a day in a diary on 0 to 5 scale, where 0=none and 5=severe. Higher score represent higher severity. The average of the morning and evening assessments were calculated for each day. Weekly average scores were calculated based on the daily scores in the week.
Outcome measures
| Measure |
Placebo
n=318 Participants
Participants self-administered HL036 placebo (vehicle solution) as topical ophthalmic drops, BID for up to 8 weeks. Exposures to the CAE® were conducted at Day 1, Day 15, Day 29 and Day 57.
|
0.25% HL036 Ophthalmic Solution
n=316 Participants
Participants self-administered HL036 0.25 % ophthalmic solution as topical ophthalmic drops BID for up to 8 weeks. Exposures to the CAE® were conducted at Day 1, Day 15, Day 29 and Day 57.
|
|---|---|---|
|
Daily Diary: Change From Baseline in Ora Calibra® Ocular Discomfort & 4-Symptom Questionnaire for Dry Eye (Burning)
Day -14 - Day -1 (Baseline) Daily Average
|
1.8 score on a scale
Standard Deviation 1.21
|
1.9 score on a scale
Standard Deviation 1.21
|
|
Daily Diary: Change From Baseline in Ora Calibra® Ocular Discomfort & 4-Symptom Questionnaire for Dry Eye (Burning)
Day 1 - Day 7, Daily Average Change from Baseline
|
-0.1 score on a scale
Standard Deviation 0.53
|
-0.1 score on a scale
Standard Deviation 0.44
|
|
Daily Diary: Change From Baseline in Ora Calibra® Ocular Discomfort & 4-Symptom Questionnaire for Dry Eye (Burning)
Day 8 - Day 14, Daily Average Change from Baseline
|
-0.2 score on a scale
Standard Deviation 0.60
|
-0.2 score on a scale
Standard Deviation 0.58
|
|
Daily Diary: Change From Baseline in Ora Calibra® Ocular Discomfort & 4-Symptom Questionnaire for Dry Eye (Burning)
Day 15 - Day 21, Daily Average Change from Baseline
|
-0.2 score on a scale
Standard Deviation 0.69
|
-0.2 score on a scale
Standard Deviation 0.63
|
|
Daily Diary: Change From Baseline in Ora Calibra® Ocular Discomfort & 4-Symptom Questionnaire for Dry Eye (Burning)
Day 22 - Day 28, Daily Average Change from Baseline
|
-0.3 score on a scale
Standard Deviation 0.75
|
-0.3 score on a scale
Standard Deviation 0.69
|
|
Daily Diary: Change From Baseline in Ora Calibra® Ocular Discomfort & 4-Symptom Questionnaire for Dry Eye (Burning)
Day 29 - Day 35, Daily Average Change from Baseline
|
-0.3 score on a scale
Standard Deviation 0.80
|
-0.3 score on a scale
Standard Deviation 0.71
|
|
Daily Diary: Change From Baseline in Ora Calibra® Ocular Discomfort & 4-Symptom Questionnaire for Dry Eye (Burning)
Day 36 - Day 42, Daily Average Change from Baseline
|
-0.3 score on a scale
Standard Deviation 0.83
|
-0.3 score on a scale
Standard Deviation 0.73
|
|
Daily Diary: Change From Baseline in Ora Calibra® Ocular Discomfort & 4-Symptom Questionnaire for Dry Eye (Burning)
Day 43 - Day 49, Daily Average Change from Baseline
|
-0.3 score on a scale
Standard Deviation 0.87
|
-0.3 score on a scale
Standard Deviation 0.78
|
|
Daily Diary: Change From Baseline in Ora Calibra® Ocular Discomfort & 4-Symptom Questionnaire for Dry Eye (Burning)
Day 50 - Day 56, Daily Average Change from Baseline
|
-0.4 score on a scale
Standard Deviation 0.92
|
-0.3 score on a scale
Standard Deviation 0.82
|
SECONDARY outcome
Timeframe: From Day -14 to Day 56Population: Number of participants analyzed included participants in ITT Population with available data. The analysis was carried out with observed data only.
Ora Calibra® ocular discomfort \& 4-symptom questionnaire for dry eye includes rating of the severity of 5 symptoms: ocular discomfort, burning, dryness, grittiness, and stinging. Participants rated the severity of dryness twice a day in a diary on 0 to 5 scale, where 0=none and 5=severe. Higher score represent higher severity. The average of the morning and evening assessments were calculated for each day. Weekly average scores were calculated based on the daily scores in the week.
Outcome measures
| Measure |
Placebo
n=318 Participants
Participants self-administered HL036 placebo (vehicle solution) as topical ophthalmic drops, BID for up to 8 weeks. Exposures to the CAE® were conducted at Day 1, Day 15, Day 29 and Day 57.
|
0.25% HL036 Ophthalmic Solution
n=316 Participants
Participants self-administered HL036 0.25 % ophthalmic solution as topical ophthalmic drops BID for up to 8 weeks. Exposures to the CAE® were conducted at Day 1, Day 15, Day 29 and Day 57.
|
|---|---|---|
|
Daily Diary: Change From Baseline in Ora Calibra® Ocular Discomfort & 4-Symptom Questionnaire for Dry Eye (Dryness)
Day -14 - Day -1 (Baseline) Daily Average
|
2.9 score on a scale
Standard Deviation 0.97
|
3.0 score on a scale
Standard Deviation 0.94
|
|
Daily Diary: Change From Baseline in Ora Calibra® Ocular Discomfort & 4-Symptom Questionnaire for Dry Eye (Dryness)
Day 1 - Day 7, Daily Average Change from Baseline
|
-0.1 score on a scale
Standard Deviation 0.46
|
-0.1 score on a scale
Standard Deviation 0.47
|
|
Daily Diary: Change From Baseline in Ora Calibra® Ocular Discomfort & 4-Symptom Questionnaire for Dry Eye (Dryness)
Day 8 - Day 14, Daily Average Change from Baseline
|
-0.2 score on a scale
Standard Deviation 0.57
|
-0.3 score on a scale
Standard Deviation 0.58
|
|
Daily Diary: Change From Baseline in Ora Calibra® Ocular Discomfort & 4-Symptom Questionnaire for Dry Eye (Dryness)
Day 15 - Day 21, Daily Average Change from Baseline
|
-0.3 score on a scale
Standard Deviation 0.68
|
-0.3 score on a scale
Standard Deviation 0.66
|
|
Daily Diary: Change From Baseline in Ora Calibra® Ocular Discomfort & 4-Symptom Questionnaire for Dry Eye (Dryness)
Day 22 - Day 28, Daily Average Change from Baseline
|
-0.4 score on a scale
Standard Deviation 0.74
|
-0.4 score on a scale
Standard Deviation 0.74
|
|
Daily Diary: Change From Baseline in Ora Calibra® Ocular Discomfort & 4-Symptom Questionnaire for Dry Eye (Dryness)
Day 29 - Day 35, Daily Average Change from Baseline
|
-0.3 score on a scale
Standard Deviation 0.77
|
-0.4 score on a scale
Standard Deviation 0.78
|
|
Daily Diary: Change From Baseline in Ora Calibra® Ocular Discomfort & 4-Symptom Questionnaire for Dry Eye (Dryness)
Day 36 - Day 42, Daily Average Change from Baseline
|
-0.4 score on a scale
Standard Deviation 0.84
|
-0.5 score on a scale
Standard Deviation 0.81
|
|
Daily Diary: Change From Baseline in Ora Calibra® Ocular Discomfort & 4-Symptom Questionnaire for Dry Eye (Dryness)
Day 43 - Day 49, Daily Average Change from Baseline
|
-0.5 score on a scale
Standard Deviation 0.88
|
-0.5 score on a scale
Standard Deviation 0.88
|
|
Daily Diary: Change From Baseline in Ora Calibra® Ocular Discomfort & 4-Symptom Questionnaire for Dry Eye (Dryness)
Day 50 - Day 56, Daily Average Change from Baseline
|
-0.5 score on a scale
Standard Deviation 0.93
|
-0.5 score on a scale
Standard Deviation 0.88
|
SECONDARY outcome
Timeframe: From Day -14 to Day 56Population: Number of participants analyzed included participants in ITT Population with available data. The analysis was carried out with observed data only.
Ora Calibra® ocular discomfort \& 4-symptom questionnaire for dry eye includes rating of the severity of 5 symptoms: ocular discomfort, burning, dryness, grittiness, and stinging. Participants rated the severity of grittiness twice a day in a diary on 0 to 5 scale, where 0=none and 5=severe. Higher score represent higher severity. The average of the morning and evening assessments were calculated for each day. Weekly average scores were calculated based on the daily scores in the week.
Outcome measures
| Measure |
Placebo
n=318 Participants
Participants self-administered HL036 placebo (vehicle solution) as topical ophthalmic drops, BID for up to 8 weeks. Exposures to the CAE® were conducted at Day 1, Day 15, Day 29 and Day 57.
|
0.25% HL036 Ophthalmic Solution
n=316 Participants
Participants self-administered HL036 0.25 % ophthalmic solution as topical ophthalmic drops BID for up to 8 weeks. Exposures to the CAE® were conducted at Day 1, Day 15, Day 29 and Day 57.
|
|---|---|---|
|
Daily Diary: Change From Baseline in Ora Calibra® Ocular Discomfort & 4-Symptom Questionnaire for Dry Eye (Grittiness)
Day -14 - Day -1 (Baseline) Daily Average
|
2.0 score on a scale
Standard Deviation 1.27
|
2.1 score on a scale
Standard Deviation 1.26
|
|
Daily Diary: Change From Baseline in Ora Calibra® Ocular Discomfort & 4-Symptom Questionnaire for Dry Eye (Grittiness)
Day 1 - Day 7, Daily Average Change from Baseline
|
-0.1 score on a scale
Standard Deviation 0.57
|
-0.2 score on a scale
Standard Deviation 0.49
|
|
Daily Diary: Change From Baseline in Ora Calibra® Ocular Discomfort & 4-Symptom Questionnaire for Dry Eye (Grittiness)
Day 8 - Day 14, Daily Average Change from Baseline
|
-0.2 score on a scale
Standard Deviation 0.64
|
-0.3 score on a scale
Standard Deviation 0.64
|
|
Daily Diary: Change From Baseline in Ora Calibra® Ocular Discomfort & 4-Symptom Questionnaire for Dry Eye (Grittiness)
Day 15 - Day 21, Daily Average Change from Baseline
|
-0.2 score on a scale
Standard Deviation 0.71
|
-0.3 score on a scale
Standard Deviation 0.69
|
|
Daily Diary: Change From Baseline in Ora Calibra® Ocular Discomfort & 4-Symptom Questionnaire for Dry Eye (Grittiness)
Day 22 - Day 28, Daily Average Change from Baseline
|
-0.3 score on a scale
Standard Deviation 0.77
|
-0.4 score on a scale
Standard Deviation 0.75
|
|
Daily Diary: Change From Baseline in Ora Calibra® Ocular Discomfort & 4-Symptom Questionnaire for Dry Eye (Grittiness)
Day 29 - Day 35, Daily Average Change from Baseline
|
-0.3 score on a scale
Standard Deviation 0.79
|
-0.4 score on a scale
Standard Deviation 0.77
|
|
Daily Diary: Change From Baseline in Ora Calibra® Ocular Discomfort & 4-Symptom Questionnaire for Dry Eye (Grittiness)
Day 36 - Day 42, Daily Average Change from Baseline
|
-0.3 score on a scale
Standard Deviation 0.85
|
-0.4 score on a scale
Standard Deviation 0.76
|
|
Daily Diary: Change From Baseline in Ora Calibra® Ocular Discomfort & 4-Symptom Questionnaire for Dry Eye (Grittiness)
Day 43 - Day 49, Daily Average Change from Baseline
|
-0.4 score on a scale
Standard Deviation 0.88
|
-0.4 score on a scale
Standard Deviation 0.84
|
|
Daily Diary: Change From Baseline in Ora Calibra® Ocular Discomfort & 4-Symptom Questionnaire for Dry Eye (Grittiness)
Day 50 - Day 56, Daily Average Change from Baseline
|
-0.4 score on a scale
Standard Deviation 0.93
|
-0.4 score on a scale
Standard Deviation 0.85
|
SECONDARY outcome
Timeframe: From Day -14 to Day 56Population: Number of participants analyzed included participants in ITT Population with available data. The analysis was carried out with observed data only.
Ora Calibra® ocular discomfort \& 4-symptom questionnaire for dry eye includes rating of the severity of 5 symptoms: ocular discomfort, burning, dryness, grittiness, and stinging. Participants rated the severity of stinging twice a day in a diary on 0 to 5 scale, where 0=none and 5=severe. Higher score represent higher severity. The average of the morning and evening assessments were calculated for each day. Weekly average scores were calculated based on the daily scores in the week.
Outcome measures
| Measure |
Placebo
n=318 Participants
Participants self-administered HL036 placebo (vehicle solution) as topical ophthalmic drops, BID for up to 8 weeks. Exposures to the CAE® were conducted at Day 1, Day 15, Day 29 and Day 57.
|
0.25% HL036 Ophthalmic Solution
n=316 Participants
Participants self-administered HL036 0.25 % ophthalmic solution as topical ophthalmic drops BID for up to 8 weeks. Exposures to the CAE® were conducted at Day 1, Day 15, Day 29 and Day 57.
|
|---|---|---|
|
Daily Diary: Change From Baseline in Ora Calibra® Ocular Discomfort & 4-Symptom Questionnaire for Dry Eye (Stinging)
Day -14 - Day -1 (Baseline) Daily Average
|
1.7 score on a scale
Standard Deviation 1.23
|
1.7 score on a scale
Standard Deviation 1.25
|
|
Daily Diary: Change From Baseline in Ora Calibra® Ocular Discomfort & 4-Symptom Questionnaire for Dry Eye (Stinging)
Day 1 - Day 7, Daily Average Change from Baseline
|
-0.1 score on a scale
Standard Deviation 0.53
|
-0.1 score on a scale
Standard Deviation 0.48
|
|
Daily Diary: Change From Baseline in Ora Calibra® Ocular Discomfort & 4-Symptom Questionnaire for Dry Eye (Stinging)
Day 8 - Day 14, Daily Average Change from Baseline
|
-0.2 score on a scale
Standard Deviation 0.60
|
-0.3 score on a scale
Standard Deviation 0.62
|
|
Daily Diary: Change From Baseline in Ora Calibra® Ocular Discomfort & 4-Symptom Questionnaire for Dry Eye (Stinging)
Day 15 - Day 21, Daily Average Change from Baseline
|
-0.3 score on a scale
Standard Deviation 0.65
|
-0.3 score on a scale
Standard Deviation 0.68
|
|
Daily Diary: Change From Baseline in Ora Calibra® Ocular Discomfort & 4-Symptom Questionnaire for Dry Eye (Stinging)
Day 22 - Day 28, Daily Average Change from Baseline
|
-0.3 score on a scale
Standard Deviation 0.70
|
-0.4 score on a scale
Standard Deviation 0.72
|
|
Daily Diary: Change From Baseline in Ora Calibra® Ocular Discomfort & 4-Symptom Questionnaire for Dry Eye (Stinging)
Day 29 - Day 35, Daily Average Change from Baseline
|
-0.3 score on a scale
Standard Deviation 0.73
|
-0.4 score on a scale
Standard Deviation 0.74
|
|
Daily Diary: Change From Baseline in Ora Calibra® Ocular Discomfort & 4-Symptom Questionnaire for Dry Eye (Stinging)
Day 36 - Day 42, Daily Average Change from Baseline
|
-0.3 score on a scale
Standard Deviation 0.79
|
-0.4 score on a scale
Standard Deviation 0.76
|
|
Daily Diary: Change From Baseline in Ora Calibra® Ocular Discomfort & 4-Symptom Questionnaire for Dry Eye (Stinging)
Day 43 - Day 49, Daily Average Change from Baseline
|
-0.4 score on a scale
Standard Deviation 0.82
|
-0.4 score on a scale
Standard Deviation 0.79
|
|
Daily Diary: Change From Baseline in Ora Calibra® Ocular Discomfort & 4-Symptom Questionnaire for Dry Eye (Stinging)
Day 50 - Day 56, Daily Average Change from Baseline
|
-0.4 score on a scale
Standard Deviation 0.86
|
-0.4 score on a scale
Standard Deviation 0.84
|
Adverse Events
0.25% HL036 Ophthalmic Solution
Serious events: 5 serious events
Other events: 78 other events
Deaths: 1 deaths
Placebo
Serious events: 4 serious events
Other events: 76 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
0.25% HL036 Ophthalmic Solution
n=318 participants at risk
Participants self-administered HL036 0.25 percent (%) ophthalmic solution as topical ophthalmic drops, twice daily (BID) for up to 8 weeks. Exposures to the controlled adverse environment® (CAE) were conducted at Day 1, Day 15, Day 29 and Day 57.
|
Placebo
n=319 participants at risk
Participants sefl-administered HL036 placebo matching vehicle solution as topical ophthalmic drops, BID for up to 8 weeks. Exposures to the controlled adverse environment® (CAE) were conducted at Day 1, Day 15, Day 29 and Day 57.
|
|---|---|---|
|
Infections and infestations
Appendiceal abscess
|
0.31%
1/318 • Number of events 1 • Baseline up to 8 weeks
|
0.00%
0/319 • Baseline up to 8 weeks
|
|
Infections and infestations
Appendicitis
|
0.31%
1/318 • Number of events 1 • Baseline up to 8 weeks
|
0.00%
0/319 • Baseline up to 8 weeks
|
|
Infections and infestations
Diverticulitis
|
0.00%
0/318 • Baseline up to 8 weeks
|
0.31%
1/319 • Number of events 1 • Baseline up to 8 weeks
|
|
Infections and infestations
Osteomyelitis
|
0.00%
0/318 • Baseline up to 8 weeks
|
0.31%
1/319 • Number of events 1 • Baseline up to 8 weeks
|
|
Musculoskeletal and connective tissue disorders
Intervertebral disc protrusion
|
0.31%
1/318 • Number of events 1 • Baseline up to 8 weeks
|
0.00%
0/319 • Baseline up to 8 weeks
|
|
Musculoskeletal and connective tissue disorders
Osteoarthritis
|
0.00%
0/318 • Baseline up to 8 weeks
|
0.31%
1/319 • Number of events 1 • Baseline up to 8 weeks
|
|
Cardiac disorders
Acute myocardial infarction
|
0.00%
0/318 • Baseline up to 8 weeks
|
0.31%
1/319 • Number of events 1 • Baseline up to 8 weeks
|
|
Cardiac disorders
Ventricular fibrillation
|
0.00%
0/318 • Baseline up to 8 weeks
|
0.31%
1/319 • Number of events 1 • Baseline up to 8 weeks
|
|
Gastrointestinal disorders
Gastrointestinal haemorrhage
|
0.00%
0/318 • Baseline up to 8 weeks
|
0.31%
1/319 • Number of events 1 • Baseline up to 8 weeks
|
|
Investigations
Blood pressure increased
|
0.31%
1/318 • Number of events 1 • Baseline up to 8 weeks
|
0.00%
0/319 • Baseline up to 8 weeks
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lung adenocarcinoma stage IV
|
0.31%
1/318 • Number of events 1 • Baseline up to 8 weeks
|
0.00%
0/319 • Baseline up to 8 weeks
|
|
Respiratory, thoracic and mediastinal disorders
Acute respiratory failure
|
0.31%
1/318 • Number of events 1 • Baseline up to 8 weeks
|
0.00%
0/319 • Baseline up to 8 weeks
|
|
Vascular disorders
Peripheral arterial occlusive disease
|
0.00%
0/318 • Baseline up to 8 weeks
|
0.31%
1/319 • Number of events 1 • Baseline up to 8 weeks
|
|
Infections and infestations
Peritonitis
|
0.31%
1/318 • Number of events 1 • Baseline up to 8 weeks
|
0.00%
0/319 • Baseline up to 8 weeks
|
Other adverse events
| Measure |
0.25% HL036 Ophthalmic Solution
n=318 participants at risk
Participants self-administered HL036 0.25 percent (%) ophthalmic solution as topical ophthalmic drops, twice daily (BID) for up to 8 weeks. Exposures to the controlled adverse environment® (CAE) were conducted at Day 1, Day 15, Day 29 and Day 57.
|
Placebo
n=319 participants at risk
Participants sefl-administered HL036 placebo matching vehicle solution as topical ophthalmic drops, BID for up to 8 weeks. Exposures to the controlled adverse environment® (CAE) were conducted at Day 1, Day 15, Day 29 and Day 57.
|
|---|---|---|
|
General disorders
Instillation site pain
|
19.5%
62/318 • Baseline up to 8 weeks
|
18.2%
58/319 • Baseline up to 8 weeks
|
|
Eye disorders
Visual acuity reduced
|
5.0%
16/318 • Baseline up to 8 weeks
|
5.6%
18/319 • Baseline up to 8 weeks
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place