Trial Outcomes & Findings for A Study to Assess the Safety and Efficacy of IC265 Ophthalmic Solution for Dry Eye in Adult Participants (NCT NCT05992922)
NCT ID: NCT05992922
Last Updated: 2025-04-25
Results Overview
Subjects will rate the severity of each of the following symptoms, with regard to how both their eyes feel, in general - overall ocular discomfort, burning, dryness, grittiness and stinging according to the following 6-point (0 to 5) scale where 0 = none and 5 = worst.
TERMINATED
PHASE2
40 participants
Change from Baseline Post-CAE® (controlled adverse environment) Day 15
2025-04-25
Participant Flow
Unit of analysis: eyes
Participant milestones
| Measure |
IC265 Ophthalmic Solution 1%
1 drop will be instilled in each eye twice daily.
IC265 Ophthalmic Solution 1%: 1 drop will be instilled in each eye twice a day
|
Placebo Ophthalmic Solution (Vehicle)
1 drop will be instilled in each eye twice daily.
Placebo Ophthalmic Solution (Vehicle): 1 drop will be instilled in each eye twice a day
|
|---|---|---|
|
Overall Study
STARTED
|
20 20
|
20 20
|
|
Overall Study
COMPLETED
|
0 0
|
0 0
|
|
Overall Study
NOT COMPLETED
|
20 20
|
20 20
|
Reasons for withdrawal
| Measure |
IC265 Ophthalmic Solution 1%
1 drop will be instilled in each eye twice daily.
IC265 Ophthalmic Solution 1%: 1 drop will be instilled in each eye twice a day
|
Placebo Ophthalmic Solution (Vehicle)
1 drop will be instilled in each eye twice daily.
Placebo Ophthalmic Solution (Vehicle): 1 drop will be instilled in each eye twice a day
|
|---|---|---|
|
Overall Study
Adverse Event
|
6
|
0
|
|
Overall Study
Sponsor Termination of Study
|
14
|
20
|
Baseline Characteristics
A Study to Assess the Safety and Efficacy of IC265 Ophthalmic Solution for Dry Eye in Adult Participants
Baseline characteristics by cohort
| Measure |
IC265 Ophthalmic Solution 1%
n=20 Participants
1 drop will be instilled in each eye twice daily.
IC265 Ophthalmic Solution 1%: 1 drop will be instilled in each eye twice a day
|
Placebo Ophthalmic Solution (Vehicle)
n=20 Participants
1 drop will be instilled in each eye twice daily.
Placebo Ophthalmic Solution (Vehicle): 1 drop will be instilled in each eye twice a day
|
Total
n=40 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
10 Participants
n=5 Participants
|
11 Participants
n=7 Participants
|
21 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
10 Participants
n=5 Participants
|
9 Participants
n=7 Participants
|
19 Participants
n=5 Participants
|
|
Age, Continuous
|
68.4 years
STANDARD_DEVIATION 8.48 • n=5 Participants
|
65.8 years
STANDARD_DEVIATION 11.5 • n=7 Participants
|
67.1 years
STANDARD_DEVIATION 10.06 • n=5 Participants
|
|
Sex: Female, Male
Female
|
11 Participants
n=5 Participants
|
13 Participants
n=7 Participants
|
24 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
9 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
16 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
20 Participants
n=5 Participants
|
20 Participants
n=7 Participants
|
40 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
|
PRIMARY outcome
Timeframe: Change from Baseline Post-CAE® (controlled adverse environment) Day 15Population: Intent to Treat - only 14 participants in the IC265 Ophthalmic Solution 1% and 19 in the Placebo Ophthalmic Solution reached Day 15.
Subjects will rate the severity of each of the following symptoms, with regard to how both their eyes feel, in general - overall ocular discomfort, burning, dryness, grittiness and stinging according to the following 6-point (0 to 5) scale where 0 = none and 5 = worst.
Outcome measures
| Measure |
IC265 Ophthalmic Solution 1%
n=14 eyes
1 drop will be instilled in each eye twice daily.
IC265 Ophthalmic Solution 1%: 1 drop will be instilled in each eye twice a day
|
Placebo Ophthalmic Solution (Vehicle)
n=19 eyes
1 drop will be instilled in each eye twice daily.
Placebo Ophthalmic Solution (Vehicle): 1 drop will be instilled in each eye twice a day
|
|---|---|---|
|
Ocular Discomfort and Dry Eye Symptoms
Overall Ocular Discomfort
|
-0.6 score on a scale
Standard Deviation 1.09
|
0.3 score on a scale
Standard Deviation 0.82
|
|
Ocular Discomfort and Dry Eye Symptoms
Burning
|
-0.5 score on a scale
Standard Deviation 1.34
|
-0.7 score on a scale
Standard Deviation 1.38
|
|
Ocular Discomfort and Dry Eye Symptoms
Dryness
|
-0.7 score on a scale
Standard Deviation 1.27
|
0.3 score on a scale
Standard Deviation 0.56
|
|
Ocular Discomfort and Dry Eye Symptoms
Grittiness
|
-0.4 score on a scale
Standard Deviation 1.22
|
0.2 score on a scale
Standard Deviation 1.38
|
|
Ocular Discomfort and Dry Eye Symptoms
Stinging
|
-0.8 score on a scale
Standard Deviation 1.63
|
-0.1 score on a scale
Standard Deviation 1.15
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Change from Baseline Pre-CAE® (controlled adverse environment) in TFBUT in Study Eye Day 15Population: Change from Baseline Pre-CAE® in TFBUT in Study Eye - Intent-to-Treat Population. Only 14 participants in the IC265 Ophthalmic Solution 1% and 19 in the Placebo Ophthalmic Solution reached Day 15.
With the aid of a slit-lamp, the examiner will monitor the integrity of the tear film, noting the time it takes to form micelles from the time that the eye is opened. TFBUT will be measured in seconds using a stopwatch and a digital image recording system for the right eye followed by the left eye. For each eye, 2 measurements will be taken and averaged unless the 2 measurements are \> 2 seconds apart and are each \< 10 seconds, in which case, a third measurement would be taken and the 2 closest of the 3 would be averaged.
Outcome measures
| Measure |
IC265 Ophthalmic Solution 1%
n=14 eyes
1 drop will be instilled in each eye twice daily.
IC265 Ophthalmic Solution 1%: 1 drop will be instilled in each eye twice a day
|
Placebo Ophthalmic Solution (Vehicle)
n=19 eyes
1 drop will be instilled in each eye twice daily.
Placebo Ophthalmic Solution (Vehicle): 1 drop will be instilled in each eye twice a day
|
|---|---|---|
|
Tear Film Break-up Time (TFBUT)
|
1.357 seconds
Standard Deviation 0.5310
|
0.883 seconds
Standard Deviation 0.4572
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Day 15Population: Only 14 participants in the IC265 Ophthalmic Solution 1% and 19 in the Placebo Ophthalmic Solution reached Day 15.
Change from baseline to Visit 3 (Day 15). Subjects will complete the OSDI© questionnaire. The OSDI© is assessed on a scale of 0 to 100, with higher scores representing greater disability. The index demonstrates sensitivity and specificity in distinguishing between normal subjects and patients with dry eye disease. the OSDI© is a valid and reliable instrument for measure dry eye disease (normal, mild to moderate, and severe) and effects vision-related function.
Outcome measures
| Measure |
IC265 Ophthalmic Solution 1%
n=14 eyes
1 drop will be instilled in each eye twice daily.
IC265 Ophthalmic Solution 1%: 1 drop will be instilled in each eye twice a day
|
Placebo Ophthalmic Solution (Vehicle)
n=19 eyes
1 drop will be instilled in each eye twice daily.
Placebo Ophthalmic Solution (Vehicle): 1 drop will be instilled in each eye twice a day
|
|---|---|---|
|
Ocular Surface Disease Index (OSDI)©
|
-3.0 score on a scale
Standard Deviation 15.45
|
-0.5 score on a scale
Standard Deviation 12.12
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Day 15Change from Baseline. Schirmer Tear Test will be performed according to the following procedure: * Using a sterile Tear Flo Schirmer test strip, a bend in the strip will be made in line with the notch in the strip. * The subject will be instructed to gaze up and in. * The Schirmer test strip will be placed in the lower temporal lid margin of each eye such that the strip fits tightly. Subjects will be instructed to close their eyes. * After 5 minutes have elapsed, the Schirmer strip will be removed. The length of the moistened area will be recorded (mm) for each eye.
Outcome measures
| Measure |
IC265 Ophthalmic Solution 1%
n=14 eyes
1 drop will be instilled in each eye twice daily.
IC265 Ophthalmic Solution 1%: 1 drop will be instilled in each eye twice a day
|
Placebo Ophthalmic Solution (Vehicle)
n=19 eyes
1 drop will be instilled in each eye twice daily.
Placebo Ophthalmic Solution (Vehicle): 1 drop will be instilled in each eye twice a day
|
|---|---|---|
|
Schirmer's Test
|
0.57 mm
Standard Deviation 3.567
|
1.95 mm
Standard Deviation 8.721
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Day 15Population: Intent to Treat - Only 14 participants in the IC265 Ophthalmic Solution 1% and 19 in the Placebo Ophthalmic Solution reached Day 15.
Change from Baseline in Ora to Visit 3 Calibra® Ocular Discomfort Scale During the CAE® in the Study Eye. Ocular discomfort scores will be subjectively graded by the subjects according to the following scale: 0 - no discomfort, 1 - intermittent awareness, 2 - constant awareness, 3 - intermittent discomfort, 4 - constant discomfort.
Outcome measures
| Measure |
IC265 Ophthalmic Solution 1%
n=14 eyes
1 drop will be instilled in each eye twice daily.
IC265 Ophthalmic Solution 1%: 1 drop will be instilled in each eye twice a day
|
Placebo Ophthalmic Solution (Vehicle)
n=19 eyes
1 drop will be instilled in each eye twice daily.
Placebo Ophthalmic Solution (Vehicle): 1 drop will be instilled in each eye twice a day
|
|---|---|---|
|
Ocular Discomfort During CAE - Change From Baseline to Visit 3
0 Minutes
|
-0.4 score on a scale
Standard Deviation 0.84
|
0.2 score on a scale
Standard Deviation 0.60
|
|
Ocular Discomfort During CAE - Change From Baseline to Visit 3
5 Minutes
|
-0.1 score on a scale
Standard Deviation 0.73
|
-0.1 score on a scale
Standard Deviation 0.85
|
|
Ocular Discomfort During CAE - Change From Baseline to Visit 3
10 Minutes
|
-0.1 score on a scale
Standard Deviation 0.66
|
-0.2 score on a scale
Standard Deviation 0.83
|
|
Ocular Discomfort During CAE - Change From Baseline to Visit 3
15 Minutes
|
0.1 score on a scale
Standard Deviation 1.00
|
0.1 score on a scale
Standard Deviation 0.71
|
|
Ocular Discomfort During CAE - Change From Baseline to Visit 3
20 Minutes
|
-0.1 score on a scale
Standard Deviation 0.86
|
0.1 score on a scale
Standard Deviation 0.62
|
|
Ocular Discomfort During CAE - Change From Baseline to Visit 3
25 Minutes
|
-0.1 score on a scale
Standard Deviation 0.73
|
0.1 score on a scale
Standard Deviation 0.97
|
|
Ocular Discomfort During CAE - Change From Baseline to Visit 3
30 Minutes
|
-0.3 score on a scale
Standard Deviation 0.73
|
0.0 score on a scale
Standard Deviation 0.75
|
|
Ocular Discomfort During CAE - Change From Baseline to Visit 3
35 Minutes
|
-0.2 score on a scale
Standard Deviation 0.80
|
0.1 score on a scale
Standard Deviation 0.85
|
|
Ocular Discomfort During CAE - Change From Baseline to Visit 3
40 Minutes
|
-0.1 score on a scale
Standard Deviation 0.77
|
0.1 score on a scale
Standard Deviation 0.66
|
|
Ocular Discomfort During CAE - Change From Baseline to Visit 3
45 Minutes
|
-0.1 score on a scale
Standard Deviation 0.77
|
0.2 score on a scale
Standard Deviation 0.60
|
|
Ocular Discomfort During CAE - Change From Baseline to Visit 3
50 Minutes
|
-0.1 score on a scale
Standard Deviation 0.77
|
0.2 score on a scale
Standard Deviation 0.60
|
|
Ocular Discomfort During CAE - Change From Baseline to Visit 3
55 Minutes
|
-0.1 score on a scale
Standard Deviation 0.77
|
0.2 score on a scale
Standard Deviation 0.63
|
|
Ocular Discomfort During CAE - Change From Baseline to Visit 3
60 Minutes
|
0.0 score on a scale
Standard Deviation 0.55
|
0.4 score on a scale
Standard Deviation 0.68
|
|
Ocular Discomfort During CAE - Change From Baseline to Visit 3
65 Minutes
|
-0.1 score on a scale
Standard Deviation 0.47
|
0.2 score on a scale
Standard Deviation 0.71
|
|
Ocular Discomfort During CAE - Change From Baseline to Visit 3
70 Minutes
|
0.0 score on a scale
Standard Deviation 0.55
|
0.1 score on a scale
Standard Deviation 0.71
|
|
Ocular Discomfort During CAE - Change From Baseline to Visit 3
75 Minutes
|
0.0 score on a scale
Standard Deviation 0.55
|
0.2 score on a scale
Standard Deviation 0.69
|
|
Ocular Discomfort During CAE - Change From Baseline to Visit 3
80 Minutes
|
0.1 score on a scale
Standard Deviation 0.47
|
0.2 score on a scale
Standard Deviation 0.96
|
|
Ocular Discomfort During CAE - Change From Baseline to Visit 3
85 Minutes
|
0.0 score on a scale
Standard Deviation 0.39
|
0.1 score on a scale
Standard Deviation 0.78
|
|
Ocular Discomfort During CAE - Change From Baseline to Visit 3
90 Minutes
|
0.0 score on a scale
Standard Deviation 0.39
|
0.1 score on a scale
Standard Deviation 0.52
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Daily Diary Evening - Day 8 to Day 14Population: Intent to Treat - Only 14 participants in the IC265 Ophthalmic Solution 1% and 19 in the Placebo Ophthalmic Solution provided daily diaries in this timeframe.
Subject Daily Diary in the Evening - Day 8 to Day 14 average, Subjects will rate the severity of each of the following symptoms, with regard to how both their eyes feel, in general - overall ocular discomfort, burning, dryness, grittiness and stinging according to the following 6-point (0 to 5) scale where 0 = none and 5 = worst.The average of the daily diary scores will be summarized using continuous descriptive statistics for the time period.
Outcome measures
| Measure |
IC265 Ophthalmic Solution 1%
n=14 Participants
1 drop will be instilled in each eye twice daily.
IC265 Ophthalmic Solution 1%: 1 drop will be instilled in each eye twice a day
|
Placebo Ophthalmic Solution (Vehicle)
n=19 Participants
1 drop will be instilled in each eye twice daily.
Placebo Ophthalmic Solution (Vehicle): 1 drop will be instilled in each eye twice a day
|
|---|---|---|
|
Daily Diary Symptom Score
Ocular Discomfort
|
2.6 score on a scale
Standard Deviation 1.30
|
2.2 score on a scale
Standard Deviation 1.06
|
|
Daily Diary Symptom Score
Burning
|
1.3 score on a scale
Standard Deviation 1.2
|
1.5 score on a scale
Standard Deviation 1.28
|
|
Daily Diary Symptom Score
Dryness
|
2.7 score on a scale
Standard Deviation 1.21
|
2.6 score on a scale
Standard Deviation 0.99
|
|
Daily Diary Symptom Score
Grittiness
|
2.1 score on a scale
Standard Deviation 1.45
|
1.2 score on a scale
Standard Deviation 1.24
|
|
Daily Diary Symptom Score
Stinging
|
1.3 score on a scale
Standard Deviation 1.25
|
1.3 score on a scale
Standard Deviation 1.38
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Change from Baseline to Day 15Population: Intent to Treat - Only 14 participants in the IC265 Ophthalmic Solution 1% and 19 in the Placebo Ophthalmic Solution provided daily diaries in this timeframe.
Conjunctival Redness 5 point scale (0 - Normal, without vasodilation, 1 - Trace ciliary or conjunctival vasodilation, 2 - Broad ciliary vasodilation, 3 - Broad ciliary and slight, horizontal conjunctival vasodilation, 4 - Broad ciliary and prominent, horizontal conjunctival vasodilation)
Outcome measures
| Measure |
IC265 Ophthalmic Solution 1%
n=14 eyes
1 drop will be instilled in each eye twice daily.
IC265 Ophthalmic Solution 1%: 1 drop will be instilled in each eye twice a day
|
Placebo Ophthalmic Solution (Vehicle)
n=19 eyes
1 drop will be instilled in each eye twice daily.
Placebo Ophthalmic Solution (Vehicle): 1 drop will be instilled in each eye twice a day
|
|---|---|---|
|
Conjunctival Redness
|
-0.3 score on a scale
Standard Deviation 15.45
|
-0.15 score on a scale
Standard Deviation 12.12
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Day 15Population: Intent-to-Treat Population - Only 14 participants in the IC265 Ophthalmic Solution 1% and 19 in the Placebo Ophthalmic Solution provided daily diaries in this timeframe.
Change from Baseline Pre-CAE® in Corneal Lissamine Green Staining in Study Eye. The staining will be graded with a Corneal and Conjunctival Staining Scale. The scale is a 5 point scale from 0 (no staining) to 4 (confluent).
Outcome measures
| Measure |
IC265 Ophthalmic Solution 1%
n=14 eyes
1 drop will be instilled in each eye twice daily.
IC265 Ophthalmic Solution 1%: 1 drop will be instilled in each eye twice a day
|
Placebo Ophthalmic Solution (Vehicle)
n=19 eyes
1 drop will be instilled in each eye twice daily.
Placebo Ophthalmic Solution (Vehicle): 1 drop will be instilled in each eye twice a day
|
|---|---|---|
|
Lissamine Green Staining in the Following Regions: Central, Superior, Inferior, Temporal, Nasal, Corneal Sum, Conjunctival Sum, and Total Eye Score
Inferior
|
0.50 score on a scale
Standard Deviation 0.920
|
0.32 score on a scale
Standard Deviation 1.017
|
|
Lissamine Green Staining in the Following Regions: Central, Superior, Inferior, Temporal, Nasal, Corneal Sum, Conjunctival Sum, and Total Eye Score
Superior
|
0.43 score on a scale
Standard Deviation 1.107
|
0.55 score on a scale
Standard Deviation 0.985
|
|
Lissamine Green Staining in the Following Regions: Central, Superior, Inferior, Temporal, Nasal, Corneal Sum, Conjunctival Sum, and Total Eye Score
Central
|
0.43 score on a scale
Standard Deviation 0.756
|
0.32 score on a scale
Standard Deviation 0.582
|
|
Lissamine Green Staining in the Following Regions: Central, Superior, Inferior, Temporal, Nasal, Corneal Sum, Conjunctival Sum, and Total Eye Score
Temporal
|
-0.07 score on a scale
Standard Deviation 0.616
|
-0.05 score on a scale
Standard Deviation 0.864
|
|
Lissamine Green Staining in the Following Regions: Central, Superior, Inferior, Temporal, Nasal, Corneal Sum, Conjunctival Sum, and Total Eye Score
Nasal
|
0.07 score on a scale
Standard Deviation 0.584
|
0.11 score on a scale
Standard Deviation 0.658
|
|
Lissamine Green Staining in the Following Regions: Central, Superior, Inferior, Temporal, Nasal, Corneal Sum, Conjunctival Sum, and Total Eye Score
Corneal Sum
|
1.36 score on a scale
Standard Deviation 2.089
|
1.18 score on a scale
Standard Deviation 2.129
|
|
Lissamine Green Staining in the Following Regions: Central, Superior, Inferior, Temporal, Nasal, Corneal Sum, Conjunctival Sum, and Total Eye Score
Conjunctival Sum
|
0.00 score on a scale
Standard Deviation 0.941
|
0.05 score on a scale
Standard Deviation 1.177
|
|
Lissamine Green Staining in the Following Regions: Central, Superior, Inferior, Temporal, Nasal, Corneal Sum, Conjunctival Sum, and Total Eye Score
Total Sum
|
1.36 score on a scale
Standard Deviation 2.825
|
1.24 score on a scale
Standard Deviation 2.791
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Day 15Population: Intent-to-Treat Population - Only 14 participants in the IC265 Ophthalmic Solution 1% and 19 in the Placebo Ophthalmic Solution provided daily diaries in this timeframe.
Change from Baseline Pre-CAE® to Post-CAE® in Corneal Fluorescein Staining in the Study Eye. The staining will be graded with a Corneal and Conjunctival Staining Scale. The scale is a 5 point scale from 0 (no staining) to 4 (confluent).
Outcome measures
| Measure |
IC265 Ophthalmic Solution 1%
n=14 eyes
1 drop will be instilled in each eye twice daily.
IC265 Ophthalmic Solution 1%: 1 drop will be instilled in each eye twice a day
|
Placebo Ophthalmic Solution (Vehicle)
n=19 eyes
1 drop will be instilled in each eye twice daily.
Placebo Ophthalmic Solution (Vehicle): 1 drop will be instilled in each eye twice a day
|
|---|---|---|
|
Fluorescein Staining in the Following Regions: Central, Superior, Inferior, Temporal, Nasal, Corneal Sum, Conjunctival Sum, and Total Eye Score
Inferior
|
-0.32 score on a scale
Standard Deviation 0.750
|
-0.55 score on a scale
Standard Deviation 0.832
|
|
Fluorescein Staining in the Following Regions: Central, Superior, Inferior, Temporal, Nasal, Corneal Sum, Conjunctival Sum, and Total Eye Score
Superior
|
-0.21 score on a scale
Standard Deviation 0.752
|
0.26 score on a scale
Standard Deviation 1.046
|
|
Fluorescein Staining in the Following Regions: Central, Superior, Inferior, Temporal, Nasal, Corneal Sum, Conjunctival Sum, and Total Eye Score
Central
|
-0.04 score on a scale
Standard Deviation 1.308
|
0.24 score on a scale
Standard Deviation 1.147
|
|
Fluorescein Staining in the Following Regions: Central, Superior, Inferior, Temporal, Nasal, Corneal Sum, Conjunctival Sum, and Total Eye Score
Temporal
|
0.07 score on a scale
Standard Deviation 0.675
|
0.39 score on a scale
Standard Deviation 0.809
|
|
Fluorescein Staining in the Following Regions: Central, Superior, Inferior, Temporal, Nasal, Corneal Sum, Conjunctival Sum, and Total Eye Score
Nasal
|
0.11 score on a scale
Standard Deviation 0.836
|
-0.08 score on a scale
Standard Deviation 0.886
|
|
Fluorescein Staining in the Following Regions: Central, Superior, Inferior, Temporal, Nasal, Corneal Sum, Conjunctival Sum, and Total Eye Score
Corneal Sum
|
-0.57 score on a scale
Standard Deviation 2.165
|
-0.05 score on a scale
Standard Deviation 2.598
|
|
Fluorescein Staining in the Following Regions: Central, Superior, Inferior, Temporal, Nasal, Corneal Sum, Conjunctival Sum, and Total Eye Score
Conjunctival Sum
|
0.18 score on a scale
Standard Deviation 0.868
|
0.32 score on a scale
Standard Deviation 1.406
|
|
Fluorescein Staining in the Following Regions: Central, Superior, Inferior, Temporal, Nasal, Corneal Sum, Conjunctival Sum, and Total Eye Score
Total Sum
|
-0.39 score on a scale
Standard Deviation 2.558
|
0.26 score on a scale
Standard Deviation 3.048
|
Adverse Events
IC265 Ophthalmic Solution 1%
Placebo Ophthalmic Solution (Vehicle)
Serious adverse events
| Measure |
IC265 Ophthalmic Solution 1%
n=20 participants at risk
1 drop will be instilled in each eye twice daily.
IC265 Ophthalmic Solution 1%: 1 drop will be instilled in each eye twice a day
|
Placebo Ophthalmic Solution (Vehicle)
n=20 participants at risk
1 drop will be instilled in each eye twice daily.
Placebo Ophthalmic Solution (Vehicle): 1 drop will be instilled in each eye twice a day
|
|---|---|---|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Glioma
|
5.0%
1/20 • Number of events 1 • The adverse events were collected over the duration of the trial out to Visit 3, Day 15. The study was terminated early and patients were discontinued from study drug.
|
0.00%
0/20 • The adverse events were collected over the duration of the trial out to Visit 3, Day 15. The study was terminated early and patients were discontinued from study drug.
|
Other adverse events
| Measure |
IC265 Ophthalmic Solution 1%
n=20 participants at risk
1 drop will be instilled in each eye twice daily.
IC265 Ophthalmic Solution 1%: 1 drop will be instilled in each eye twice a day
|
Placebo Ophthalmic Solution (Vehicle)
n=20 participants at risk
1 drop will be instilled in each eye twice daily.
Placebo Ophthalmic Solution (Vehicle): 1 drop will be instilled in each eye twice a day
|
|---|---|---|
|
Eye disorders
Corneal neovascularisation
|
0.00%
0/20 • The adverse events were collected over the duration of the trial out to Visit 3, Day 15. The study was terminated early and patients were discontinued from study drug.
|
5.0%
1/20 • Number of events 1 • The adverse events were collected over the duration of the trial out to Visit 3, Day 15. The study was terminated early and patients were discontinued from study drug.
|
|
Eye disorders
Corneal Opacity
|
55.0%
11/20 • Number of events 11 • The adverse events were collected over the duration of the trial out to Visit 3, Day 15. The study was terminated early and patients were discontinued from study drug.
|
0.00%
0/20 • The adverse events were collected over the duration of the trial out to Visit 3, Day 15. The study was terminated early and patients were discontinued from study drug.
|
|
Eye disorders
Eye Pruritus
|
10.0%
2/20 • Number of events 2 • The adverse events were collected over the duration of the trial out to Visit 3, Day 15. The study was terminated early and patients were discontinued from study drug.
|
0.00%
0/20 • The adverse events were collected over the duration of the trial out to Visit 3, Day 15. The study was terminated early and patients were discontinued from study drug.
|
|
Eye disorders
Instillation site foreign body sensation
|
5.0%
1/20 • Number of events 1 • The adverse events were collected over the duration of the trial out to Visit 3, Day 15. The study was terminated early and patients were discontinued from study drug.
|
0.00%
0/20 • The adverse events were collected over the duration of the trial out to Visit 3, Day 15. The study was terminated early and patients were discontinued from study drug.
|
|
Eye disorders
Instillation site irritation
|
75.0%
15/20 • Number of events 16 • The adverse events were collected over the duration of the trial out to Visit 3, Day 15. The study was terminated early and patients were discontinued from study drug.
|
10.0%
2/20 • Number of events 2 • The adverse events were collected over the duration of the trial out to Visit 3, Day 15. The study was terminated early and patients were discontinued from study drug.
|
|
Eye disorders
Lacrimation Increased
|
5.0%
1/20 • Number of events 1 • The adverse events were collected over the duration of the trial out to Visit 3, Day 15. The study was terminated early and patients were discontinued from study drug.
|
0.00%
0/20 • The adverse events were collected over the duration of the trial out to Visit 3, Day 15. The study was terminated early and patients were discontinued from study drug.
|
|
Eye disorders
Vision Blurred
|
25.0%
5/20 • Number of events 5 • The adverse events were collected over the duration of the trial out to Visit 3, Day 15. The study was terminated early and patients were discontinued from study drug.
|
5.0%
1/20 • Number of events 1 • The adverse events were collected over the duration of the trial out to Visit 3, Day 15. The study was terminated early and patients were discontinued from study drug.
|
|
Eye disorders
Visual Acuity reduced
|
5.0%
1/20 • Number of events 1 • The adverse events were collected over the duration of the trial out to Visit 3, Day 15. The study was terminated early and patients were discontinued from study drug.
|
5.0%
1/20 • Number of events 1 • The adverse events were collected over the duration of the trial out to Visit 3, Day 15. The study was terminated early and patients were discontinued from study drug.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place