Trial Outcomes & Findings for Study of ST-100 as Treatment for Dry Eye Disease (NCT NCT05241470)
NCT ID: NCT05241470
Last Updated: 2024-03-13
Results Overview
The fluorescein staining is graded with the Ora Calibra® Corneal and Conjunctival Staining Scale. The scale is used to evaluate 3 corneal regions. Staining in each region is graded 0 to 4 where 0 means no staining, and 4 means worst staining. Higher score indicates more staining. The scoring reported ranges from 0-12. Mean change from baseline was calculated.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
160 participants
Primary outcome timeframe
Visit 2 (Day 1) to Visit 7 (Day 29)
Results posted on
2024-03-13
Participant Flow
All participants participated in the run-in phase of the study before randomization.
Unit of analysis: Eyes
Participant milestones
| Measure |
Low Dose ST-100 Ophthalmic Solution
Low Dose ST100-001 Ophthalmic solution, 20mcg/ml
ST-100 Ophthalmic Solution: One drop in each eye twice a day
|
High Dose ST-100 Ophthalmic Solution
High Dose ST100-001 Ophthalmic Solution, 50mcg/ml
ST-100 Ophthalmic Solution: One drop in each eye twice a day
|
Placebo Ophthalmic Solution
Placebo Ophthalmic Solution (vehicle)
Placebo Ophthalmic Solution: One drop in each eye twice a day
|
Run-In
Run-In Phase
|
|---|---|---|---|---|
|
Placebo Run-In
STARTED
|
0 0
|
0 0
|
0 0
|
160 320
|
|
Placebo Run-In
COMPLETED
|
0 0
|
0 0
|
0 0
|
160 320
|
|
Placebo Run-In
NOT COMPLETED
|
0 0
|
0 0
|
0 0
|
0 0
|
|
Randomized Study
STARTED
|
53 106
|
53 106
|
54 108
|
0 0
|
|
Randomized Study
COMPLETED
|
48 96
|
50 100
|
48 96
|
0 0
|
|
Randomized Study
NOT COMPLETED
|
5 10
|
3 6
|
6 12
|
0 0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Study of ST-100 as Treatment for Dry Eye Disease
Baseline characteristics by cohort
| Measure |
Low Dose ST-100 Ophthalmic Solution
n=53 Participants
Low Dose ST100-001 Ophthalmic solution, 20mg/ml
ST-100 Ophthalmic Solution: One drop in each eye twice a day
|
High Dose ST-100 Ophthalmic Solution
n=53 Participants
High Dose ST100-001 Ophthalmic Solution, 50mg/ml
ST-100 Ophthalmic Solution: One drop in each eye twice a day
|
Placebo Ophthalmic Solution
n=54 Participants
Placebo Ophthalmic Solution (vehicle)
Placebo Ophthalmic Solution: One drop in each eye twice a day
|
Total
n=160 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
64.4 years
STANDARD_DEVIATION 10.29 • n=5 Participants
|
61.9 years
STANDARD_DEVIATION 11.60 • n=7 Participants
|
63.4 years
STANDARD_DEVIATION 13.28 • n=5 Participants
|
63.2 years
STANDARD_DEVIATION 11.77 • n=4 Participants
|
|
Sex: Female, Male
Female
|
40 Participants
n=5 Participants
|
29 Participants
n=7 Participants
|
43 Participants
n=5 Participants
|
112 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
13 Participants
n=5 Participants
|
24 Participants
n=7 Participants
|
11 Participants
n=5 Participants
|
48 Participants
n=4 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Asian
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Black or African American
|
15 Participants
n=5 Participants
|
15 Participants
n=7 Participants
|
18 Participants
n=5 Participants
|
48 Participants
n=4 Participants
|
|
Race (NIH/OMB)
White
|
35 Participants
n=5 Participants
|
38 Participants
n=7 Participants
|
36 Participants
n=5 Participants
|
109 Participants
n=4 Participants
|
|
Race (NIH/OMB)
More than one race
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Total Corneal Fluorescein Staining
|
4.78 units on a scale
STANDARD_DEVIATION 0.781 • n=5 Participants
|
4.86 units on a scale
STANDARD_DEVIATION 1.094 • n=7 Participants
|
4.81 units on a scale
STANDARD_DEVIATION 0.928 • n=5 Participants
|
4.82 units on a scale
STANDARD_DEVIATION 0.937 • n=4 Participants
|
|
Ocular Discomfort Scale
|
2.6 units on a scale
STANDARD_DEVIATION 1.06 • n=5 Participants
|
2.4 units on a scale
STANDARD_DEVIATION 1.04 • n=7 Participants
|
2.5 units on a scale
STANDARD_DEVIATION 1.11 • n=5 Participants
|
2.5 units on a scale
STANDARD_DEVIATION 1.07 • n=4 Participants
|
|
Unanesthetized Schirmer's test
|
4.4 mm
STANDARD_DEVIATION 2.77 • n=5 Participants
|
5.2 mm
STANDARD_DEVIATION 2.84 • n=7 Participants
|
5.0 mm
STANDARD_DEVIATION 2.87 • n=5 Participants
|
4.9 mm
STANDARD_DEVIATION 2.83 • n=4 Participants
|
PRIMARY outcome
Timeframe: Visit 2 (Day 1) to Visit 7 (Day 29)The fluorescein staining is graded with the Ora Calibra® Corneal and Conjunctival Staining Scale. The scale is used to evaluate 3 corneal regions. Staining in each region is graded 0 to 4 where 0 means no staining, and 4 means worst staining. Higher score indicates more staining. The scoring reported ranges from 0-12. Mean change from baseline was calculated.
Outcome measures
| Measure |
Low Dose ST-100 Ophthalmic Solution
n=53 Study Eye
Low Dose ST100-001 Ophthalmic solution, 20mg/ml
ST-100 Ophthalmic Solution: One drop in each eye twice a day
|
High Dose ST-100 Ophthalmic Solution
n=53 Study Eye
High Dose ST100-001 Ophthalmic Solution, 50mg/ml
ST-100 Ophthalmic Solution: One drop in each eye twice a day
|
Placebo Ophthalmic Solution
n=54 Study Eye
Placebo Ophthalmic Solution (vehicle)
Placebo Ophthalmic Solution: One drop in each eye twice a day
|
|---|---|---|---|
|
Change From Baseline of Total Corneal Fluorescein Staining (Ora Calibra® Scale) in the Study Eye at Visit 7 (Day 29) Pre-Controlled Adverse Environment (Pre-CAE)
|
-0.17 units on a scale
Standard Error 0.186
|
-0.17 units on a scale
Standard Error 0.182
|
-0.18 units on a scale
Standard Error 0.185
|
PRIMARY outcome
Timeframe: Visit 2 (Day 1) to Visit 7 (Day 29)Ocular Discomfort Scale is graded using the Ora Calibra Ocular Discomfort Scale (ODS). The scale ranges from 0 means no discomfort to 4 means worst discomfort. Higher score indicates more discomfort.
Outcome measures
| Measure |
Low Dose ST-100 Ophthalmic Solution
n=53 Study Eye
Low Dose ST100-001 Ophthalmic solution, 20mg/ml
ST-100 Ophthalmic Solution: One drop in each eye twice a day
|
High Dose ST-100 Ophthalmic Solution
n=53 Study Eye
High Dose ST100-001 Ophthalmic Solution, 50mg/ml
ST-100 Ophthalmic Solution: One drop in each eye twice a day
|
Placebo Ophthalmic Solution
n=54 Study Eye
Placebo Ophthalmic Solution (vehicle)
Placebo Ophthalmic Solution: One drop in each eye twice a day
|
|---|---|---|---|
|
Change From Baseline of Ocular Discomfort in the Study Eye at Visit 7 (Day 29) Pre-CAE
|
-0.3 score on a scale
Standard Error 0.14
|
-0.4 score on a scale
Standard Error 0.13
|
-0.3 score on a scale
Standard Error 0.14
|
SECONDARY outcome
Timeframe: Visit 7 (Day 29), Pre-CAEPopulation: The measurements are reported for each visit. The number of subjects in each group varied at each visit. The overall analyzed number of participants are from the ITT population.
The Schirmer's test strip is placed in the lower temporal lid margin of each eye. After 5 minutes, the test strip is removed and the length of the moistened area will be recorded in millimeters (mm) for each eye. The percentage of responders who had ≥ 10 mm increase from baseline in study eye in unanesthetized Schirmer's test was recorded.
Outcome measures
| Measure |
Low Dose ST-100 Ophthalmic Solution
n=53 Participants
Low Dose ST100-001 Ophthalmic solution, 20mg/ml
ST-100 Ophthalmic Solution: One drop in each eye twice a day
|
High Dose ST-100 Ophthalmic Solution
n=53 Participants
High Dose ST100-001 Ophthalmic Solution, 50mg/ml
ST-100 Ophthalmic Solution: One drop in each eye twice a day
|
Placebo Ophthalmic Solution
n=54 Participants
Placebo Ophthalmic Solution (vehicle)
Placebo Ophthalmic Solution: One drop in each eye twice a day
|
|---|---|---|---|
|
Unanesthetized Schirmer's Responder Rate
|
48 Participants
|
49 Participants
|
48 Participants
|
SECONDARY outcome
Timeframe: Visit 3 (Day 2)Population: The measurements are reported for each visit. The number of subjects in each group varied at each visit. The overall analyzed number of participants are from the ITT population.
LogMAR visual acuity (VA) is assessed using an Early Treatment Diabetic Retinopathy Study (ETDRS) chart. The last line in which a letter is read correctly will be taken as the base logMAR reading. To this value will be added the number "N x 0.02" where 'N' represents the total number of letters missed up to and included in the last line read. This total sum represents the logMAR VA for that eye.
Outcome measures
| Measure |
Low Dose ST-100 Ophthalmic Solution
n=52 Fellow Eye
Low Dose ST100-001 Ophthalmic solution, 20mg/ml
ST-100 Ophthalmic Solution: One drop in each eye twice a day
|
High Dose ST-100 Ophthalmic Solution
n=53 Fellow Eye
High Dose ST100-001 Ophthalmic Solution, 50mg/ml
ST-100 Ophthalmic Solution: One drop in each eye twice a day
|
Placebo Ophthalmic Solution
n=54 Fellow Eye
Placebo Ophthalmic Solution (vehicle)
Placebo Ophthalmic Solution: One drop in each eye twice a day
|
|---|---|---|---|
|
Change From Baseline of Best-Corrected Visual Acuity (ETDRS) - logMAR (Fellow Eye) at Visit 3 (Day 2)
|
-0.003 logMAR
Standard Error 0.0104
|
-0.028 logMAR
Standard Error 0.0104
|
0013 logMAR
Standard Error 0.0103
|
SECONDARY outcome
Timeframe: Visit 4 (Day 4), Non-CAEPopulation: The measurements are reported for each visit. The number of subjects in each group varied at each visit. The overall analyzed number of participants are from the ITT population.
Ocular Surface Disease Index (OSDI) Questions 4: Have you experienced blurred vision during the last week? on 0-4 Scale where 4 is the worst at pre-CAE®
Outcome measures
| Measure |
Low Dose ST-100 Ophthalmic Solution
n=53 Study Eye
Low Dose ST100-001 Ophthalmic solution, 20mg/ml
ST-100 Ophthalmic Solution: One drop in each eye twice a day
|
High Dose ST-100 Ophthalmic Solution
n=53 Study Eye
High Dose ST100-001 Ophthalmic Solution, 50mg/ml
ST-100 Ophthalmic Solution: One drop in each eye twice a day
|
Placebo Ophthalmic Solution
n=54 Study Eye
Placebo Ophthalmic Solution (vehicle)
Placebo Ophthalmic Solution: One drop in each eye twice a day
|
|---|---|---|---|
|
Change From Baseline to Visit 4 (Day 4) in Ocular Surface Disease Index (Blurred Vision)
|
-0.1 score on a scale
Standard Error 0.12
|
-0.3 score on a scale
Standard Error 0.12
|
0.2 score on a scale
Standard Error 0.12
|
SECONDARY outcome
Timeframe: Visit 6 (Day 15) Pre-CAEPopulation: The measurements are reported for each visit. The number of subjects in each group varied slightly at each visit. The overall number analyzed are reported based on the ITT population. \-
Ocular Surface Disease Index (OSDI) Questions 3: Have you experienced painful or sore eyes during the last week? on 0-4 Scale where 4 is the worst at pre-CAE®
Outcome measures
| Measure |
Low Dose ST-100 Ophthalmic Solution
n=49 Study Eye
Low Dose ST100-001 Ophthalmic solution, 20mg/ml
ST-100 Ophthalmic Solution: One drop in each eye twice a day
|
High Dose ST-100 Ophthalmic Solution
n=51 Study Eye
High Dose ST100-001 Ophthalmic Solution, 50mg/ml
ST-100 Ophthalmic Solution: One drop in each eye twice a day
|
Placebo Ophthalmic Solution
n=49 Study Eye
Placebo Ophthalmic Solution (vehicle)
Placebo Ophthalmic Solution: One drop in each eye twice a day
|
|---|---|---|---|
|
Change From Baseline to Visit 6 (Day 15) in Ocular Surface Disease Index (Pain)
|
-0.1 score on a scale
Standard Error 0.11
|
-0.4 score on a scale
Standard Error 0.11
|
0.0 score on a scale
Standard Error 0.11
|
SECONDARY outcome
Timeframe: Visit 6 (Day 15) Pre-CAEPopulation: The measurements are reported for each visit. The number of subjects in each group varied slightly at each visit. The overall analyzed number of participants were from the ITT population
The Ora Calibra® Ocular Discomfort \& 4-Symptom Questionnaire is used, which includes rating of the severity of 5 symptoms: ocular discomfort, burning, dryness, grittiness, and stinging. Each symptom rating ranges from 0 to 5, where 0 = None and 5 = Worst. Higher score means worse symptom. Min score = 0, max score = 25.
Outcome measures
| Measure |
Low Dose ST-100 Ophthalmic Solution
n=49 Study Eye
Low Dose ST100-001 Ophthalmic solution, 20mg/ml
ST-100 Ophthalmic Solution: One drop in each eye twice a day
|
High Dose ST-100 Ophthalmic Solution
n=51 Study Eye
High Dose ST100-001 Ophthalmic Solution, 50mg/ml
ST-100 Ophthalmic Solution: One drop in each eye twice a day
|
Placebo Ophthalmic Solution
n=49 Study Eye
Placebo Ophthalmic Solution (vehicle)
Placebo Ophthalmic Solution: One drop in each eye twice a day
|
|---|---|---|---|
|
Change From Baseline in Ocular Discomfort Assessed by 4-Symptom Questionnaire
|
-0.2 score on a scale
Standard Error 0.11
|
-0.4 score on a scale
Standard Error 0.11
|
0.0 score on a scale
Standard Error 0.11
|
POST_HOC outcome
Timeframe: Visit 7 (Day 28) Pre CAEPopulation: The analysis was done on both study and fellow eyes combined
The fluorescein staining is graded with the Ora Calibra® Corneal and Conjunctival Staining Scale. The scale is used to evaluate inferior, superior, central, temporal, and nasal region. Staining in each region is graded 0 to 4 where 0 means no staining, and 4 means worst staining. Higher score indicates more staining. The corneal sum score is the sum of scores from the inferior, superior, and central regions (min 0, max 12). The conjunctival sum score is the sum of scores from the nasal and temporal regions (min 0, max 8). The total eye score is the sum of scores from all five regions (min 0, max 20). The average values of both eyes assessment were reported (min 0, max 20)
Outcome measures
| Measure |
Low Dose ST-100 Ophthalmic Solution
n=100 Eyes
Low Dose ST100-001 Ophthalmic solution, 20mg/ml
ST-100 Ophthalmic Solution: One drop in each eye twice a day
|
High Dose ST-100 Ophthalmic Solution
n=96 Eyes
High Dose ST100-001 Ophthalmic Solution, 50mg/ml
ST-100 Ophthalmic Solution: One drop in each eye twice a day
|
Placebo Ophthalmic Solution
n=96 Eyes
Placebo Ophthalmic Solution (vehicle)
Placebo Ophthalmic Solution: One drop in each eye twice a day
|
|---|---|---|---|
|
Change From Baseline in Fluorescein Staining in the Total Eye Sum - Both Eyes Together
|
-0.33 units on a scale
Standard Deviation 1.660
|
-0.42 units on a scale
Standard Deviation 1.810
|
0.16 units on a scale
Standard Deviation 2.075
|
POST_HOC outcome
Timeframe: Visit 7 (Day 28), Pre CAEPopulation: The analysis was done on both study and fellow eyes combined
The fluorescein staining is graded with the Ora Calibra® Corneal and Conjunctival Staining Scale. The scale is used to evaluate inferior, superior, central, temporal, and nasal region. Staining in each region is graded 0 to 4 where 0 means no staining, and 4 means worst staining. Higher score indicates more staining. The corneal sum score is the sum of scores from the inferior, superior, and central regions (min 0, max 12). The conjunctival sum score is the sum of scores from the nasal and temporal regions (min 0, max 8). The total eye score is the sum of scores from all five regions (min 0, max 20). The average values of both eyes assessment were reported (min 0, max 20).
Outcome measures
| Measure |
Low Dose ST-100 Ophthalmic Solution
n=100 Total Eyes
Low Dose ST100-001 Ophthalmic solution, 20mg/ml
ST-100 Ophthalmic Solution: One drop in each eye twice a day
|
High Dose ST-100 Ophthalmic Solution
n=96 Total Eyes
High Dose ST100-001 Ophthalmic Solution, 50mg/ml
ST-100 Ophthalmic Solution: One drop in each eye twice a day
|
Placebo Ophthalmic Solution
n=96 Total Eyes
Placebo Ophthalmic Solution (vehicle)
Placebo Ophthalmic Solution: One drop in each eye twice a day
|
|---|---|---|---|
|
Change From Baseline in Fluorescein Staining in Conjunctival Sum - Both Eyes Together
|
-0.01 units on a scale
Standard Deviation 0.793
|
-0.14 units on a scale
Standard Deviation 1.057
|
0.17 units on a scale
Standard Deviation 1.007
|
POST_HOC outcome
Timeframe: Visit 7 (Day 28), Pre-CAEPopulation: The count is based on the study and fellow eyes combined
The fluorescein staining is graded with the Ora Calibra® Corneal and Conjunctival Staining Scale. The scale is used to evaluate inferior, superior, central, temporal, and nasal region. Staining in each region is graded 0 to 4 where 0 means no staining, and 4 means worst staining. Higher score indicates more staining. This assessment reported the staining score in temporal region using the Corneal and Conjunctival Fluorescein Staining Scale (min 0, max 4). The average values of both eyes assessment were reported (min 0, max 4).
Outcome measures
| Measure |
Low Dose ST-100 Ophthalmic Solution
n=100 Total Eyes
Low Dose ST100-001 Ophthalmic solution, 20mg/ml
ST-100 Ophthalmic Solution: One drop in each eye twice a day
|
High Dose ST-100 Ophthalmic Solution
n=96 Total Eyes
High Dose ST100-001 Ophthalmic Solution, 50mg/ml
ST-100 Ophthalmic Solution: One drop in each eye twice a day
|
Placebo Ophthalmic Solution
n=96 Total Eyes
Placebo Ophthalmic Solution (vehicle)
Placebo Ophthalmic Solution: One drop in each eye twice a day
|
|---|---|---|---|
|
Change From Baseline in Fluorescein Staining in the Temporal Region - Both Eyes Together
|
-0.07 units on a scale
Standard Deviation 0.479
|
-0.07 units on a scale
Standard Deviation 0.644
|
0.12 units on a scale
Standard Deviation 0.593
|
POST_HOC outcome
Timeframe: Baseline, Visit 5 (Day 7), Visit 6 (Day 14), and Visit 7 (Day 28)Population: Analysis was done on ITT population with Observed Data Only. The number analyzed in one or more rows differs from overall number analyzed because the number of participants/study eye analyzed can vary with each visit.
Ocular Discomfort Scale is graded using the Ora Calibra Ocular Discomfort Scale (ODS). The scale ranges from 0 means no discomfort to 4 means worst discomfort. Higher score indicates more discomfort. Area under the curve is presented. AUC at each visit is calculated as follows: Calculate (time point - previous time point)\*0.5\*(discomfort score at time point + previous discomfort score at time point) then sum all of those values together. Given that this was taken every 5 minutes from 0 to 90 minutes, the maximum value for AUC would then be (5\*0.5\*8)\*18=360, and the minimum value would be (5\*0.5\*0)\*18=0. Given this, the minimum and maximum change from baseline would be -360 to 360.
Outcome measures
| Measure |
Low Dose ST-100 Ophthalmic Solution
n=53 Study Eye
Low Dose ST100-001 Ophthalmic solution, 20mg/ml
ST-100 Ophthalmic Solution: One drop in each eye twice a day
|
High Dose ST-100 Ophthalmic Solution
n=53 Study Eye
High Dose ST100-001 Ophthalmic Solution, 50mg/ml
ST-100 Ophthalmic Solution: One drop in each eye twice a day
|
Placebo Ophthalmic Solution
n=54 Study Eye
Placebo Ophthalmic Solution (vehicle)
Placebo Ophthalmic Solution: One drop in each eye twice a day
|
|---|---|---|---|
|
Change From Baseline in Ocular Discomfort Scale (Ora Calibra Scale) During the CAE - Area Under the Curve
Change from Baseline to Visit 5 (Day 7), 5 Minutes
|
-0.76 Score on a scale*min
Standard Error 0.511
|
-1.05 Score on a scale*min
Standard Error 0.501
|
-0.18 Score on a scale*min
Standard Error 0.506
|
|
Change From Baseline in Ocular Discomfort Scale (Ora Calibra Scale) During the CAE - Area Under the Curve
Change from Baseline to Visit 5 (Day 7), 45 Minutes
|
-6.98 Score on a scale*min
Standard Error 3.791
|
-13.10 Score on a scale*min
Standard Error 3.713
|
-5.39 Score on a scale*min
Standard Error 3.743
|
|
Change From Baseline in Ocular Discomfort Scale (Ora Calibra Scale) During the CAE - Area Under the Curve
Change from Baseline to Visit 5 (Day 7), 90 Minutes
|
-9.82 Score on a scale*min
Standard Error 6.570
|
-17.43 Score on a scale*min
Standard Error 6.430
|
-5.70 Score on a scale*min
Standard Error 6.487
|
|
Change From Baseline in Ocular Discomfort Scale (Ora Calibra Scale) During the CAE - Area Under the Curve
Change from Baseline to Visit 6 (Day 14), 5 Minutes
|
0.13 Score on a scale*min
Standard Error 0.542
|
-1.54 Score on a scale*min
Standard Error 0.542
|
-0.30 Score on a scale*min
Standard Error 0.537
|
|
Change From Baseline in Ocular Discomfort Scale (Ora Calibra Scale) During the CAE - Area Under the Curve
Change from Baseline to Visit 6 (Day 14), 45 Minutes
|
-8.15 Score on a scale*min
Standard Error 3.727
|
-16.46 Score on a scale*min
Standard Error 3.729
|
-9.36 Score on a scale*min
Standard Error 3.683
|
|
Change From Baseline in Ocular Discomfort Scale (Ora Calibra Scale) During the CAE - Area Under the Curve
Change from Baseline to Visit 6 (Day 14), 90 Minutes
|
-9.32 Score on a scale*min
Standard Error 6.621
|
-22.34 Score on a scale*min
Standard Error 6.619
|
-16.89 Score on a scale*min
Standard Error 6.539
|
|
Change From Baseline in Ocular Discomfort Scale (Ora Calibra Scale) During the CAE - Area Under the Curve
Change from Baseline to Visit 7 (Day 28), 5 Minutes
|
-0.28 Score on a scale*min
Standard Error 0.576
|
-1.49 Score on a scale*min
Standard Error 0.565
|
-0.77 Score on a scale*min
Standard Error 0.576
|
|
Change From Baseline in Ocular Discomfort Scale (Ora Calibra Scale) During the CAE - Area Under the Curve
Change from Baseline to Visit 7 (Day 28), 45 Minutes
|
-8.58 Score on a scale*min
Standard Error 4.676
|
-19.27 Score on a scale*min
Standard Error 4.578
|
-11.18 Score on a scale*min
Standard Error 4.661
|
|
Change From Baseline in Ocular Discomfort Scale (Ora Calibra Scale) During the CAE - Area Under the Curve
Change from Baseline to Visit 7 (Day 28), 90 Minutes
|
-17.64 Score on a scale*min
Standard Error 8.266
|
-32.20 Score on a scale*min
Standard Error 8.085
|
-21.48 Score on a scale*min
Standard Error 8.238
|
Adverse Events
Low Dose ST-100 Ophthalmic Solution
Serious events: 1 serious events
Other events: 6 other events
Deaths: 0 deaths
High Dose ST-100 Ophthalmic Solution
Serious events: 0 serious events
Other events: 6 other events
Deaths: 0 deaths
Placebo Ophthalmic Solution
Serious events: 2 serious events
Other events: 8 other events
Deaths: 1 deaths
Run-In
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Low Dose ST-100 Ophthalmic Solution
n=52 participants at risk
Low Dose ST100-001 Ophthalmic solution, 20mg/ml
ST-100 Ophthalmic Solution: One drop in each eye twice a day
|
High Dose ST-100 Ophthalmic Solution
n=53 participants at risk
High Dose ST100-001 Ophthalmic Solution, 50mg/ml
ST-100 Ophthalmic Solution: One drop in each eye twice a day
|
Placebo Ophthalmic Solution
n=54 participants at risk
Placebo Ophthalmic Solution (vehicle)
Placebo Ophthalmic Solution: One drop in each eye twice a day
|
Run-In
n=160 participants at risk
Run-In Phase
|
|---|---|---|---|---|
|
Respiratory, thoracic and mediastinal disorders
Respiratory Depression related to congestive heart failure
|
0.00%
0/52 • Through study completion, an average of 1 month
Safety population: 52 in low dose, 53 in high dose, 54 in Placebo. ST-100 was safe and well tolerated in the study. There were no meaningful imbalances among treatment groups in either ocular or non-ocular treatment emergent adverse events. All serious adverse events were considered unexpected and not related to study drug. Other AEs \> 5% (reduced VA and instillation site pain) were seen in one or at most two early visits but were no longer seen in the same patients as the trial progressed.
|
0.00%
0/53 • Through study completion, an average of 1 month
Safety population: 52 in low dose, 53 in high dose, 54 in Placebo. ST-100 was safe and well tolerated in the study. There were no meaningful imbalances among treatment groups in either ocular or non-ocular treatment emergent adverse events. All serious adverse events were considered unexpected and not related to study drug. Other AEs \> 5% (reduced VA and instillation site pain) were seen in one or at most two early visits but were no longer seen in the same patients as the trial progressed.
|
1.9%
1/54 • Through study completion, an average of 1 month
Safety population: 52 in low dose, 53 in high dose, 54 in Placebo. ST-100 was safe and well tolerated in the study. There were no meaningful imbalances among treatment groups in either ocular or non-ocular treatment emergent adverse events. All serious adverse events were considered unexpected and not related to study drug. Other AEs \> 5% (reduced VA and instillation site pain) were seen in one or at most two early visits but were no longer seen in the same patients as the trial progressed.
|
0.00%
0/160 • Through study completion, an average of 1 month
Safety population: 52 in low dose, 53 in high dose, 54 in Placebo. ST-100 was safe and well tolerated in the study. There were no meaningful imbalances among treatment groups in either ocular or non-ocular treatment emergent adverse events. All serious adverse events were considered unexpected and not related to study drug. Other AEs \> 5% (reduced VA and instillation site pain) were seen in one or at most two early visits but were no longer seen in the same patients as the trial progressed.
|
|
General disorders
Poor organ function
|
0.00%
0/52 • Through study completion, an average of 1 month
Safety population: 52 in low dose, 53 in high dose, 54 in Placebo. ST-100 was safe and well tolerated in the study. There were no meaningful imbalances among treatment groups in either ocular or non-ocular treatment emergent adverse events. All serious adverse events were considered unexpected and not related to study drug. Other AEs \> 5% (reduced VA and instillation site pain) were seen in one or at most two early visits but were no longer seen in the same patients as the trial progressed.
|
0.00%
0/53 • Through study completion, an average of 1 month
Safety population: 52 in low dose, 53 in high dose, 54 in Placebo. ST-100 was safe and well tolerated in the study. There were no meaningful imbalances among treatment groups in either ocular or non-ocular treatment emergent adverse events. All serious adverse events were considered unexpected and not related to study drug. Other AEs \> 5% (reduced VA and instillation site pain) were seen in one or at most two early visits but were no longer seen in the same patients as the trial progressed.
|
1.9%
1/54 • Through study completion, an average of 1 month
Safety population: 52 in low dose, 53 in high dose, 54 in Placebo. ST-100 was safe and well tolerated in the study. There were no meaningful imbalances among treatment groups in either ocular or non-ocular treatment emergent adverse events. All serious adverse events were considered unexpected and not related to study drug. Other AEs \> 5% (reduced VA and instillation site pain) were seen in one or at most two early visits but were no longer seen in the same patients as the trial progressed.
|
0.00%
0/160 • Through study completion, an average of 1 month
Safety population: 52 in low dose, 53 in high dose, 54 in Placebo. ST-100 was safe and well tolerated in the study. There were no meaningful imbalances among treatment groups in either ocular or non-ocular treatment emergent adverse events. All serious adverse events were considered unexpected and not related to study drug. Other AEs \> 5% (reduced VA and instillation site pain) were seen in one or at most two early visits but were no longer seen in the same patients as the trial progressed.
|
|
Skin and subcutaneous tissue disorders
Cellulitis
|
1.9%
1/52 • Through study completion, an average of 1 month
Safety population: 52 in low dose, 53 in high dose, 54 in Placebo. ST-100 was safe and well tolerated in the study. There were no meaningful imbalances among treatment groups in either ocular or non-ocular treatment emergent adverse events. All serious adverse events were considered unexpected and not related to study drug. Other AEs \> 5% (reduced VA and instillation site pain) were seen in one or at most two early visits but were no longer seen in the same patients as the trial progressed.
|
0.00%
0/53 • Through study completion, an average of 1 month
Safety population: 52 in low dose, 53 in high dose, 54 in Placebo. ST-100 was safe and well tolerated in the study. There were no meaningful imbalances among treatment groups in either ocular or non-ocular treatment emergent adverse events. All serious adverse events were considered unexpected and not related to study drug. Other AEs \> 5% (reduced VA and instillation site pain) were seen in one or at most two early visits but were no longer seen in the same patients as the trial progressed.
|
0.00%
0/54 • Through study completion, an average of 1 month
Safety population: 52 in low dose, 53 in high dose, 54 in Placebo. ST-100 was safe and well tolerated in the study. There were no meaningful imbalances among treatment groups in either ocular or non-ocular treatment emergent adverse events. All serious adverse events were considered unexpected and not related to study drug. Other AEs \> 5% (reduced VA and instillation site pain) were seen in one or at most two early visits but were no longer seen in the same patients as the trial progressed.
|
0.00%
0/160 • Through study completion, an average of 1 month
Safety population: 52 in low dose, 53 in high dose, 54 in Placebo. ST-100 was safe and well tolerated in the study. There were no meaningful imbalances among treatment groups in either ocular or non-ocular treatment emergent adverse events. All serious adverse events were considered unexpected and not related to study drug. Other AEs \> 5% (reduced VA and instillation site pain) were seen in one or at most two early visits but were no longer seen in the same patients as the trial progressed.
|
Other adverse events
| Measure |
Low Dose ST-100 Ophthalmic Solution
n=52 participants at risk
Low Dose ST100-001 Ophthalmic solution, 20mg/ml
ST-100 Ophthalmic Solution: One drop in each eye twice a day
|
High Dose ST-100 Ophthalmic Solution
n=53 participants at risk
High Dose ST100-001 Ophthalmic Solution, 50mg/ml
ST-100 Ophthalmic Solution: One drop in each eye twice a day
|
Placebo Ophthalmic Solution
n=54 participants at risk
Placebo Ophthalmic Solution (vehicle)
Placebo Ophthalmic Solution: One drop in each eye twice a day
|
Run-In
n=160 participants at risk
Run-In Phase
|
|---|---|---|---|---|
|
Eye disorders
Visual acuity reduced
|
3.8%
2/52 • Through study completion, an average of 1 month
Safety population: 52 in low dose, 53 in high dose, 54 in Placebo. ST-100 was safe and well tolerated in the study. There were no meaningful imbalances among treatment groups in either ocular or non-ocular treatment emergent adverse events. All serious adverse events were considered unexpected and not related to study drug. Other AEs \> 5% (reduced VA and instillation site pain) were seen in one or at most two early visits but were no longer seen in the same patients as the trial progressed.
|
5.7%
3/53 • Through study completion, an average of 1 month
Safety population: 52 in low dose, 53 in high dose, 54 in Placebo. ST-100 was safe and well tolerated in the study. There were no meaningful imbalances among treatment groups in either ocular or non-ocular treatment emergent adverse events. All serious adverse events were considered unexpected and not related to study drug. Other AEs \> 5% (reduced VA and instillation site pain) were seen in one or at most two early visits but were no longer seen in the same patients as the trial progressed.
|
5.6%
3/54 • Through study completion, an average of 1 month
Safety population: 52 in low dose, 53 in high dose, 54 in Placebo. ST-100 was safe and well tolerated in the study. There were no meaningful imbalances among treatment groups in either ocular or non-ocular treatment emergent adverse events. All serious adverse events were considered unexpected and not related to study drug. Other AEs \> 5% (reduced VA and instillation site pain) were seen in one or at most two early visits but were no longer seen in the same patients as the trial progressed.
|
0.00%
0/160 • Through study completion, an average of 1 month
Safety population: 52 in low dose, 53 in high dose, 54 in Placebo. ST-100 was safe and well tolerated in the study. There were no meaningful imbalances among treatment groups in either ocular or non-ocular treatment emergent adverse events. All serious adverse events were considered unexpected and not related to study drug. Other AEs \> 5% (reduced VA and instillation site pain) were seen in one or at most two early visits but were no longer seen in the same patients as the trial progressed.
|
|
General disorders
Instillation site pain
|
7.7%
4/52 • Through study completion, an average of 1 month
Safety population: 52 in low dose, 53 in high dose, 54 in Placebo. ST-100 was safe and well tolerated in the study. There were no meaningful imbalances among treatment groups in either ocular or non-ocular treatment emergent adverse events. All serious adverse events were considered unexpected and not related to study drug. Other AEs \> 5% (reduced VA and instillation site pain) were seen in one or at most two early visits but were no longer seen in the same patients as the trial progressed.
|
5.7%
3/53 • Through study completion, an average of 1 month
Safety population: 52 in low dose, 53 in high dose, 54 in Placebo. ST-100 was safe and well tolerated in the study. There were no meaningful imbalances among treatment groups in either ocular or non-ocular treatment emergent adverse events. All serious adverse events were considered unexpected and not related to study drug. Other AEs \> 5% (reduced VA and instillation site pain) were seen in one or at most two early visits but were no longer seen in the same patients as the trial progressed.
|
9.3%
5/54 • Through study completion, an average of 1 month
Safety population: 52 in low dose, 53 in high dose, 54 in Placebo. ST-100 was safe and well tolerated in the study. There were no meaningful imbalances among treatment groups in either ocular or non-ocular treatment emergent adverse events. All serious adverse events were considered unexpected and not related to study drug. Other AEs \> 5% (reduced VA and instillation site pain) were seen in one or at most two early visits but were no longer seen in the same patients as the trial progressed.
|
0.00%
0/160 • Through study completion, an average of 1 month
Safety population: 52 in low dose, 53 in high dose, 54 in Placebo. ST-100 was safe and well tolerated in the study. There were no meaningful imbalances among treatment groups in either ocular or non-ocular treatment emergent adverse events. All serious adverse events were considered unexpected and not related to study drug. Other AEs \> 5% (reduced VA and instillation site pain) were seen in one or at most two early visits but were no longer seen in the same patients as the trial progressed.
|
Additional Information
Brian Del Buono, Executive Vice President
Stuart Therapeutics
Phone: 7034025866
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: GT60