Trial Outcomes & Findings for A Research Study To See How Well an Eye Drop, SURF-100 (A Mycophenolic Acid/Betamethasone Sodium Phosphate Combination), Works and What Side Effects There Are in Subjects With Dry Eye Disease (NCT NCT04734197)
NCT ID: NCT04734197
Last Updated: 2025-05-11
Results Overview
The UNC DEMS scale is a participant-specific 10-point scale with a minimum score of 1 (\[1-2\] My symptoms are not a problem. My dry eye does not affect my daily life at all) and a maximum score of 10 (\[9-10\] my symptoms are severe and I need immediate medical care. My dry eye greatly affects my daily life). Participants with a 10% or higher reduction in UNC DEMS score from baseline were defined as responders, and response rates were summarized by treatment group.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
349 participants
Primary outcome timeframe
Baseline and Day 84
Results posted on
2025-05-11
Participant Flow
Prior to each participant's assignment by chance to one of the seven treatment arms/groups (randomization), the Investigator designated the participant's Study Eye. The participant's Study Eye was the eye that was eligible for the study and had the worst signs and symptoms. The participant's other eye was called the Fellow Eye.
Unit of analysis: Study Eyes
Participant milestones
| Measure |
SURF-100
Eye drop:
Topical, preservative-free SURF-100 (a combination of 0.3% mycophenolic acid and 0.01% betamethasone sodium phosphate)
Dosing: One drop in the study eye (and fellow eye, if applicable) twice daily for 84 days.
|
Mycophenolic Acid 0.1%
Eye drop:
Topical, preservative-free mycophenolic acid 0.1%
Dosing: One drop in the study eye (and fellow eye, if applicable) twice daily for 84 days.
|
Mycophenolic Acid 0.3%
Eye drop:
Topical preservative-free mycophenolic acid 0.3%
Dosing: One drop in the study eye (and fellow eye, if applicable) twice daily for 84 days.
|
Betamethasone Sodium Phosphate 0.01%
Eye drop:
Topical preservative free betamethasone sodium phosphate 0.01%
Dosing: One drop in the study eye (and fellow eye, if applicable) twice daily for 84 days.
|
Placebo Comparator: Vehicle
Eye drop:
Topical preservative-free placebo comparator (vehicle)
Dosing: One drop in the study eye (and fellow eye, if applicable) twice daily for 84 days.
|
Cyclosporine 0.05% Ophthalmic Emulsion
Eye drop:
Topical preservative-free cyclosporine 0.05% ophthalmic emulsion
Dosing: One drop in the study eye (and fellow eye, if applicable) twice daily for 84 days.
|
Lifitegrast 5% Ophthalmic Solution
Eye drop:
Topical, preservative-free lifitegrast 5% ophthalmic solution
Dosing: One drop in the study eye (and fellow eye, if applicable) twice daily for 84 days.
|
|---|---|---|---|---|---|---|---|
|
Overall Study
STARTED
|
52 52
|
50 50
|
50 50
|
49 49
|
47 47
|
47 47
|
54 54
|
|
Overall Study
COMPLETED
|
44 44
|
46 46
|
44 44
|
44 44
|
44 44
|
43 43
|
43 43
|
|
Overall Study
NOT COMPLETED
|
8 8
|
4 4
|
6 6
|
5 5
|
3 3
|
4 4
|
11 11
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
A Research Study To See How Well an Eye Drop, SURF-100 (A Mycophenolic Acid/Betamethasone Sodium Phosphate Combination), Works and What Side Effects There Are in Subjects With Dry Eye Disease
Baseline characteristics by cohort
| Measure |
SURF-100
n=52 Study Eyes
Eye drop:
Topical, preservative-free SURF-100 (a combination of 0.3% mycophenolic acid and 0.01% betamethasone sodium phosphate)
Dosing: One drop in the study eye (and fellow eye, if applicable) twice daily for 84 days.
|
Mycophenolic Acid 0.1%
n=50 Study Eyes
Eye drop:
Topical, preservative-free mycophenolic acid 0.1%
Dosing: One drop in the study eye (and fellow eye, if applicable) twice daily for 84 days.
|
Mycophenolic Acid 0.3%
n=50 Study Eyes
Eye drop:
Topical preservative-free mycophenolic acid 0.3%
Dosing: One drop in the study eye (and fellow eye, if applicable) twice daily for 84 days.
|
Betamethasone Sodium Phosphate 0.01%
n=49 Study Eyes
Eye drop:
Topical preservative free betamethasone sodium phosphate 0.01%
Dosing: One drop in the study eye (and fellow eye, if applicable) twice daily for 84 days.
|
Placebo Comparator: Vehicle
n=47 Study Eyes
Eye drop:
Topical preservative-free placebo comparator (vehicle)
Dosing: One drop in the study eye (and fellow eye, if applicable) twice daily for 84 days.
|
Cyclosporine 0.05% Ophthalmic Emulsion
n=47 Study Eyes
Eye drop:
Topical preservative-free cyclosporine 0.05% ophthalmic emulsion
Dosing: One drop in the study eye (and fellow eye, if applicable) twice daily for 84 days.
|
Lifitegrast 5% Ophthalmic Solution
n=54 Study Eyes
Eye drop:
Topical, preservative-free lifitegrast 5% ophthalmic solution
Dosing: One drop in the study eye (and fellow eye, if applicable) twice daily for 84 days.
|
Total
n=349 Study Eyes
Total of all reporting groups
|
|---|---|---|---|---|---|---|---|---|
|
Age, Continuous
|
61.4 years
STANDARD_DEVIATION 14.16 • n=5 Participants
|
61.4 years
STANDARD_DEVIATION 16.29 • n=7 Participants
|
60.3 years
STANDARD_DEVIATION 14.34 • n=5 Participants
|
61.8 years
STANDARD_DEVIATION 13.92 • n=4 Participants
|
60.7 years
STANDARD_DEVIATION 14.75 • n=21 Participants
|
63.2 years
STANDARD_DEVIATION 13.41 • n=8 Participants
|
62.8 years
STANDARD_DEVIATION 14.53 • n=8 Participants
|
61.7 years
STANDARD_DEVIATION 14.42 • n=24 Participants
|
|
Sex: Female, Male
Female
|
37 Participants
n=5 Participants
|
35 Participants
n=7 Participants
|
39 Participants
n=5 Participants
|
44 Participants
n=4 Participants
|
35 Participants
n=21 Participants
|
34 Participants
n=8 Participants
|
41 Participants
n=8 Participants
|
265 Participants
n=24 Participants
|
|
Sex: Female, Male
Male
|
15 Participants
n=5 Participants
|
15 Participants
n=7 Participants
|
11 Participants
n=5 Participants
|
5 Participants
n=4 Participants
|
12 Participants
n=21 Participants
|
13 Participants
n=8 Participants
|
13 Participants
n=8 Participants
|
84 Participants
n=24 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=8 Participants
|
1 Participants
n=24 Participants
|
|
Race (NIH/OMB)
Asian
|
2 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
4 Participants
n=21 Participants
|
3 Participants
n=8 Participants
|
3 Participants
n=8 Participants
|
18 Participants
n=24 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
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=24 Participants
|
|
Race (NIH/OMB)
Black or African American
|
7 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
6 Participants
n=4 Participants
|
2 Participants
n=21 Participants
|
7 Participants
n=8 Participants
|
6 Participants
n=8 Participants
|
31 Participants
n=24 Participants
|
|
Race (NIH/OMB)
White
|
40 Participants
n=5 Participants
|
42 Participants
n=7 Participants
|
47 Participants
n=5 Participants
|
41 Participants
n=4 Participants
|
41 Participants
n=21 Participants
|
36 Participants
n=8 Participants
|
44 Participants
n=8 Participants
|
291 Participants
n=24 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=8 Participants
|
2 Participants
n=24 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
2 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
1 Participants
n=8 Participants
|
1 Participants
n=8 Participants
|
6 Participants
n=24 Participants
|
|
University of North Carolina Dry Eye Management Scale (UNC DEMS) Score at Baseline
|
7.1 UNC DEMS units
STANDARD_DEVIATION 1.13 • n=5 Participants
|
6.9 UNC DEMS units
STANDARD_DEVIATION 1.23 • n=7 Participants
|
6.7 UNC DEMS units
STANDARD_DEVIATION 1.33 • n=5 Participants
|
6.7 UNC DEMS units
STANDARD_DEVIATION 1.11 • n=4 Participants
|
7.0 UNC DEMS units
STANDARD_DEVIATION 1.19 • n=21 Participants
|
6.8 UNC DEMS units
STANDARD_DEVIATION 1.07 • n=8 Participants
|
6.9 UNC DEMS units
STANDARD_DEVIATION 1.32 • n=8 Participants
|
6.9 UNC DEMS units
STANDARD_DEVIATION 1.20 • n=24 Participants
|
|
Tear Break-up Time (TBUT), Study Eye
|
3.43 seconds
STANDARD_DEVIATION 0.98 • n=52 Study Eyes
|
3.60 seconds
STANDARD_DEVIATION 0.87 • n=50 Study Eyes
|
3.41 seconds
STANDARD_DEVIATION 0.91 • n=50 Study Eyes
|
3.39 seconds
STANDARD_DEVIATION 0.87 • n=49 Study Eyes
|
3.62 seconds
STANDARD_DEVIATION 0.83 • n=47 Study Eyes
|
3.36 seconds
STANDARD_DEVIATION 0.78 • n=47 Study Eyes
|
3.43 seconds
STANDARD_DEVIATION 0.88 • n=54 Study Eyes
|
3.5 seconds
STANDARD_DEVIATION 0.88 • n=349 Study Eyes
|
|
Schirmer Tear Test (with Anesthesia), Study Eye
|
5.7 millimeters
STANDARD_DEVIATION 2.48 • n=52 Study Eyes
|
5.1 millimeters
STANDARD_DEVIATION 2.42 • n=50 Study Eyes
|
5.2 millimeters
STANDARD_DEVIATION 2.54 • n=50 Study Eyes
|
5.8 millimeters
STANDARD_DEVIATION 2.70 • n=49 Study Eyes
|
5.6 millimeters
STANDARD_DEVIATION 2.34 • n=47 Study Eyes
|
5.4 millimeters
STANDARD_DEVIATION 2.48 • n=47 Study Eyes
|
5.5 millimeters
STANDARD_DEVIATION 2.38 • n=54 Study Eyes
|
5.5 millimeters
STANDARD_DEVIATION 2.47 • n=349 Study Eyes
|
PRIMARY outcome
Timeframe: Baseline and Day 84Population: Intent-to Treat Analysis Population: Includes all randomized subjects. Missing values were imputed using last observation carried forward (LOCF). LOCF: common statistical approach to the analysis of longitudinal repeated measures where some follow-up \[FU\] observations may be missing. In a LOCF analysis, a missing FU value is replaced by/imputed as that participant's previously observed value. The combination of the observed and imputed data is then analyzed as if there were no missing data.
The UNC DEMS scale is a participant-specific 10-point scale with a minimum score of 1 (\[1-2\] My symptoms are not a problem. My dry eye does not affect my daily life at all) and a maximum score of 10 (\[9-10\] my symptoms are severe and I need immediate medical care. My dry eye greatly affects my daily life). Participants with a 10% or higher reduction in UNC DEMS score from baseline were defined as responders, and response rates were summarized by treatment group.
Outcome measures
| Measure |
SURF-100
n=52 Participants
Eye drop:
Topical, preservative-free SURF-100 (a combination of 0.3% mycophenolic acid and 0.01% betamethasone sodium phosphate)
Dosing: One drop in the study eye (and fellow eye, if applicable) twice daily for 84 days.
|
Mycophenolic Acid 0.1%
n=50 Participants
Eye drop:
Topical, preservative-free mycophenolic acid 0.1%
Dosing: One drop in the study eye (and fellow eye, if applicable) twice daily for 84 days.
|
Mycophenolic Acid 0.3%
n=50 Participants
Eye drop:
Topical preservative-free mycophenolic acid 0.3%
Dosing: One drop in the study eye (and fellow eye, if applicable) twice daily for 84 days.
|
Betamethasone Sodium Phosphate 0.01%
n=49 Participants
Eye drop:
Topical preservative free betamethasone sodium phosphate 0.01%
Dosing: One drop in the study eye (and fellow eye, if applicable) twice daily for 84 days.
|
Placebo Comparator: Vehicle
n=47 Participants
Eye drop:
Topical preservative-free placebo comparator (vehicle)
Dosing: One drop in the study eye (and fellow eye, if applicable) twice daily for 84 days.
|
Cyclosporine 0.05% Ophthalmic Emulsion
n=47 Participants
Eye drop:
Topical preservative-free cyclosporine 0.05% ophthalmic emulsion
Dosing: One drop in the study eye (and fellow eye, if applicable) twice daily for 84 days.
|
Lifitegrast 5% Ophthalmic Solution
n=54 Participants
Eye drop:
Topical, preservative-free lifitegrast 5% ophthalmic solution
Dosing: One drop in the study eye (and fellow eye, if applicable) twice daily for 84 days.
|
|---|---|---|---|---|---|---|---|
|
University of North Carolina Dry Eye Management Scale (UNC DEMS) Responder Analysis
|
65.4 percentage of responders
Interval 50.9 to 78.0
|
90.0 percentage of responders
Interval 78.2 to 96.7
|
66.0 percentage of responders
Interval 51.2 to 78.8
|
71.4 percentage of responders
Interval 56.7 to 83.4
|
80.9 percentage of responders
Interval 66.7 to 90.9
|
72.3 percentage of responders
Interval 57.4 to 84.4
|
57.4 percentage of responders
Interval 43.2 to 70.8
|
SECONDARY outcome
Timeframe: Baseline and Day 84Population: Intent-to Treat Analysis Population: It included all randomized subjects regardless of whether a study medication was taken. Missing data were not imputed. For subjects who were withdrawn from the study prior to study completion, all data compiled up to the point of subject withdrawal from the study was used for analysis.
The absolute change from baseline in TBUT in the study eye at Day 84.
Outcome measures
| Measure |
SURF-100
n=50 Study Eyes
Eye drop:
Topical, preservative-free SURF-100 (a combination of 0.3% mycophenolic acid and 0.01% betamethasone sodium phosphate)
Dosing: One drop in the study eye (and fellow eye, if applicable) twice daily for 84 days.
|
Mycophenolic Acid 0.1%
n=50 Study Eyes
Eye drop:
Topical, preservative-free mycophenolic acid 0.1%
Dosing: One drop in the study eye (and fellow eye, if applicable) twice daily for 84 days.
|
Mycophenolic Acid 0.3%
n=50 Study Eyes
Eye drop:
Topical preservative-free mycophenolic acid 0.3%
Dosing: One drop in the study eye (and fellow eye, if applicable) twice daily for 84 days.
|
Betamethasone Sodium Phosphate 0.01%
n=49 Study Eyes
Eye drop:
Topical preservative free betamethasone sodium phosphate 0.01%
Dosing: One drop in the study eye (and fellow eye, if applicable) twice daily for 84 days.
|
Placebo Comparator: Vehicle
n=47 Study Eyes
Eye drop:
Topical preservative-free placebo comparator (vehicle)
Dosing: One drop in the study eye (and fellow eye, if applicable) twice daily for 84 days.
|
Cyclosporine 0.05% Ophthalmic Emulsion
n=47 Study Eyes
Eye drop:
Topical preservative-free cyclosporine 0.05% ophthalmic emulsion
Dosing: One drop in the study eye (and fellow eye, if applicable) twice daily for 84 days.
|
Lifitegrast 5% Ophthalmic Solution
n=52 Study Eyes
Eye drop:
Topical, preservative-free lifitegrast 5% ophthalmic solution
Dosing: One drop in the study eye (and fellow eye, if applicable) twice daily for 84 days.
|
|---|---|---|---|---|---|---|---|
|
Tear Break Up Time (TBUT), Study Eye
|
1.70 seconds
Interval 0.52 to 2.88
|
1.84 seconds
Interval 0.68 to 3.0
|
1.41 seconds
Interval 0.21 to 2.6
|
2.56 seconds
Interval 1.38 to 3.75
|
1.12 seconds
Interval -0.08 to 2.33
|
2.40 seconds
Interval 1.2 to 3.59
|
1.52 seconds
Interval 0.37 to 2.68
|
SECONDARY outcome
Timeframe: Baseline and Day 84Population: Intent-to Treat (ITT) Analysis Population: It included all randomized subjects regardless of whether a study medication was taken. Missing data were not imputed. For subjects who were withdrawn from the study prior to study completion, all data compiled up to the point of subject withdrawal from the study was used for analysis.
The absolute change from baseline in Schirmer tear score in the study eye at Day 84.
Outcome measures
| Measure |
SURF-100
n=50 Study Eyes
Eye drop:
Topical, preservative-free SURF-100 (a combination of 0.3% mycophenolic acid and 0.01% betamethasone sodium phosphate)
Dosing: One drop in the study eye (and fellow eye, if applicable) twice daily for 84 days.
|
Mycophenolic Acid 0.1%
n=50 Study Eyes
Eye drop:
Topical, preservative-free mycophenolic acid 0.1%
Dosing: One drop in the study eye (and fellow eye, if applicable) twice daily for 84 days.
|
Mycophenolic Acid 0.3%
n=50 Study Eyes
Eye drop:
Topical preservative-free mycophenolic acid 0.3%
Dosing: One drop in the study eye (and fellow eye, if applicable) twice daily for 84 days.
|
Betamethasone Sodium Phosphate 0.01%
n=49 Study Eyes
Eye drop:
Topical preservative free betamethasone sodium phosphate 0.01%
Dosing: One drop in the study eye (and fellow eye, if applicable) twice daily for 84 days.
|
Placebo Comparator: Vehicle
n=47 Study Eyes
Eye drop:
Topical preservative-free placebo comparator (vehicle)
Dosing: One drop in the study eye (and fellow eye, if applicable) twice daily for 84 days.
|
Cyclosporine 0.05% Ophthalmic Emulsion
n=47 Study Eyes
Eye drop:
Topical preservative-free cyclosporine 0.05% ophthalmic emulsion
Dosing: One drop in the study eye (and fellow eye, if applicable) twice daily for 84 days.
|
Lifitegrast 5% Ophthalmic Solution
n=52 Study Eyes
Eye drop:
Topical, preservative-free lifitegrast 5% ophthalmic solution
Dosing: One drop in the study eye (and fellow eye, if applicable) twice daily for 84 days.
|
|---|---|---|---|---|---|---|---|
|
Schirmer Tear Test Score, Study Eye
|
3.20 millimeters
Interval 1.52 to 4.88
|
2.94 millimeters
Interval 1.32 to 4.57
|
4.46 millimeters
Interval 2.77 to 6.15
|
1.66 millimeters
Interval 0.0 to 3.33
|
3.98 millimeters
Interval 2.29 to 5.66
|
2.25 millimeters
Interval 0.57 to 3.92
|
2.73 millimeters
Interval 1.1 to 4.35
|
Adverse Events
SURF-100
Serious events: 1 serious events
Other events: 10 other events
Deaths: 0 deaths
Mycophenolic Acid 0.1%
Serious events: 0 serious events
Other events: 10 other events
Deaths: 0 deaths
Mycophenolic Acid 0.3%
Serious events: 1 serious events
Other events: 9 other events
Deaths: 0 deaths
Betamethasone Sodium Phosphate 0.01%
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
Placebo Comparator: Vehicle
Serious events: 0 serious events
Other events: 6 other events
Deaths: 0 deaths
Cyclosporine 0.05% Ophthalmic Emulsion
Serious events: 1 serious events
Other events: 6 other events
Deaths: 0 deaths
Lifitegrast 5% Ophthalmic Solution
Serious events: 0 serious events
Other events: 20 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
SURF-100
n=52 participants at risk
Eye drop:
Topical, preservative-free SURF-100 (a combination of 0.3% mycophenolic acid and 0.01% betamethasone sodium phosphate)
Dosing: One drop in the study eye (and fellow eye, if applicable) twice daily for 84 days.
|
Mycophenolic Acid 0.1%
n=50 participants at risk
Eye drop:
Topical, preservative-free mycophenolic acid 0.1%
Dosing: One drop in the study eye (and fellow eye, if applicable) twice daily for 84 days.
|
Mycophenolic Acid 0.3%
n=50 participants at risk
Eye drop:
Topical preservative-free mycophenolic acid 0.3%
Dosing: One drop in the study eye (and fellow eye, if applicable) twice daily for 84 days.
|
Betamethasone Sodium Phosphate 0.01%
n=49 participants at risk
Eye drop:
Topical preservative free betamethasone sodium phosphate 0.01%
Dosing: One drop in the study eye (and fellow eye, if applicable) twice daily for 84 days.
|
Placebo Comparator: Vehicle
n=47 participants at risk
Eye drop:
Topical preservative-free placebo comparator (vehicle)
Dosing: One drop in the study eye (and fellow eye, if applicable) twice daily for 84 days.
|
Cyclosporine 0.05% Ophthalmic Emulsion
n=47 participants at risk
Eye drop:
Topical preservative-free cyclosporine 0.05% ophthalmic emulsion
Dosing: One drop in the study eye (and fellow eye, if applicable) twice daily for 84 days.
|
Lifitegrast 5% Ophthalmic Solution
n=54 participants at risk
Eye drop:
Topical, preservative-free lifitegrast 5% ophthalmic solution
Dosing: One drop in the study eye (and fellow eye, if applicable) twice daily for 84 days.
|
|---|---|---|---|---|---|---|---|
|
Eye disorders
Ocular hypertension not related to study drug (pre-existing condition)
|
1.9%
1/52 • Number of events 1 • From each participant's signature of informed consent at Screening through Day 98 (completion of the study) or early withdrawal, which ever came first.
Adverse events were collected from each participant's signature of informed consent at Screening through Day 98 (completion of the study) or early withdrawal, which ever came first.
|
0.00%
0/50 • From each participant's signature of informed consent at Screening through Day 98 (completion of the study) or early withdrawal, which ever came first.
Adverse events were collected from each participant's signature of informed consent at Screening through Day 98 (completion of the study) or early withdrawal, which ever came first.
|
0.00%
0/50 • From each participant's signature of informed consent at Screening through Day 98 (completion of the study) or early withdrawal, which ever came first.
Adverse events were collected from each participant's signature of informed consent at Screening through Day 98 (completion of the study) or early withdrawal, which ever came first.
|
0.00%
0/49 • From each participant's signature of informed consent at Screening through Day 98 (completion of the study) or early withdrawal, which ever came first.
Adverse events were collected from each participant's signature of informed consent at Screening through Day 98 (completion of the study) or early withdrawal, which ever came first.
|
0.00%
0/47 • From each participant's signature of informed consent at Screening through Day 98 (completion of the study) or early withdrawal, which ever came first.
Adverse events were collected from each participant's signature of informed consent at Screening through Day 98 (completion of the study) or early withdrawal, which ever came first.
|
0.00%
0/47 • From each participant's signature of informed consent at Screening through Day 98 (completion of the study) or early withdrawal, which ever came first.
Adverse events were collected from each participant's signature of informed consent at Screening through Day 98 (completion of the study) or early withdrawal, which ever came first.
|
0.00%
0/54 • From each participant's signature of informed consent at Screening through Day 98 (completion of the study) or early withdrawal, which ever came first.
Adverse events were collected from each participant's signature of informed consent at Screening through Day 98 (completion of the study) or early withdrawal, which ever came first.
|
|
Nervous system disorders
Cerebrovascular accident
|
0.00%
0/52 • From each participant's signature of informed consent at Screening through Day 98 (completion of the study) or early withdrawal, which ever came first.
Adverse events were collected from each participant's signature of informed consent at Screening through Day 98 (completion of the study) or early withdrawal, which ever came first.
|
0.00%
0/50 • From each participant's signature of informed consent at Screening through Day 98 (completion of the study) or early withdrawal, which ever came first.
Adverse events were collected from each participant's signature of informed consent at Screening through Day 98 (completion of the study) or early withdrawal, which ever came first.
|
2.0%
1/50 • Number of events 1 • From each participant's signature of informed consent at Screening through Day 98 (completion of the study) or early withdrawal, which ever came first.
Adverse events were collected from each participant's signature of informed consent at Screening through Day 98 (completion of the study) or early withdrawal, which ever came first.
|
0.00%
0/49 • From each participant's signature of informed consent at Screening through Day 98 (completion of the study) or early withdrawal, which ever came first.
Adverse events were collected from each participant's signature of informed consent at Screening through Day 98 (completion of the study) or early withdrawal, which ever came first.
|
0.00%
0/47 • From each participant's signature of informed consent at Screening through Day 98 (completion of the study) or early withdrawal, which ever came first.
Adverse events were collected from each participant's signature of informed consent at Screening through Day 98 (completion of the study) or early withdrawal, which ever came first.
|
0.00%
0/47 • From each participant's signature of informed consent at Screening through Day 98 (completion of the study) or early withdrawal, which ever came first.
Adverse events were collected from each participant's signature of informed consent at Screening through Day 98 (completion of the study) or early withdrawal, which ever came first.
|
0.00%
0/54 • From each participant's signature of informed consent at Screening through Day 98 (completion of the study) or early withdrawal, which ever came first.
Adverse events were collected from each participant's signature of informed consent at Screening through Day 98 (completion of the study) or early withdrawal, which ever came first.
|
|
Respiratory, thoracic and mediastinal disorders
Shortness of breath
|
0.00%
0/52 • From each participant's signature of informed consent at Screening through Day 98 (completion of the study) or early withdrawal, which ever came first.
Adverse events were collected from each participant's signature of informed consent at Screening through Day 98 (completion of the study) or early withdrawal, which ever came first.
|
0.00%
0/50 • From each participant's signature of informed consent at Screening through Day 98 (completion of the study) or early withdrawal, which ever came first.
Adverse events were collected from each participant's signature of informed consent at Screening through Day 98 (completion of the study) or early withdrawal, which ever came first.
|
0.00%
0/50 • From each participant's signature of informed consent at Screening through Day 98 (completion of the study) or early withdrawal, which ever came first.
Adverse events were collected from each participant's signature of informed consent at Screening through Day 98 (completion of the study) or early withdrawal, which ever came first.
|
0.00%
0/49 • From each participant's signature of informed consent at Screening through Day 98 (completion of the study) or early withdrawal, which ever came first.
Adverse events were collected from each participant's signature of informed consent at Screening through Day 98 (completion of the study) or early withdrawal, which ever came first.
|
0.00%
0/47 • From each participant's signature of informed consent at Screening through Day 98 (completion of the study) or early withdrawal, which ever came first.
Adverse events were collected from each participant's signature of informed consent at Screening through Day 98 (completion of the study) or early withdrawal, which ever came first.
|
2.1%
1/47 • Number of events 1 • From each participant's signature of informed consent at Screening through Day 98 (completion of the study) or early withdrawal, which ever came first.
Adverse events were collected from each participant's signature of informed consent at Screening through Day 98 (completion of the study) or early withdrawal, which ever came first.
|
0.00%
0/54 • From each participant's signature of informed consent at Screening through Day 98 (completion of the study) or early withdrawal, which ever came first.
Adverse events were collected from each participant's signature of informed consent at Screening through Day 98 (completion of the study) or early withdrawal, which ever came first.
|
Other adverse events
| Measure |
SURF-100
n=52 participants at risk
Eye drop:
Topical, preservative-free SURF-100 (a combination of 0.3% mycophenolic acid and 0.01% betamethasone sodium phosphate)
Dosing: One drop in the study eye (and fellow eye, if applicable) twice daily for 84 days.
|
Mycophenolic Acid 0.1%
n=50 participants at risk
Eye drop:
Topical, preservative-free mycophenolic acid 0.1%
Dosing: One drop in the study eye (and fellow eye, if applicable) twice daily for 84 days.
|
Mycophenolic Acid 0.3%
n=50 participants at risk
Eye drop:
Topical preservative-free mycophenolic acid 0.3%
Dosing: One drop in the study eye (and fellow eye, if applicable) twice daily for 84 days.
|
Betamethasone Sodium Phosphate 0.01%
n=49 participants at risk
Eye drop:
Topical preservative free betamethasone sodium phosphate 0.01%
Dosing: One drop in the study eye (and fellow eye, if applicable) twice daily for 84 days.
|
Placebo Comparator: Vehicle
n=47 participants at risk
Eye drop:
Topical preservative-free placebo comparator (vehicle)
Dosing: One drop in the study eye (and fellow eye, if applicable) twice daily for 84 days.
|
Cyclosporine 0.05% Ophthalmic Emulsion
n=47 participants at risk
Eye drop:
Topical preservative-free cyclosporine 0.05% ophthalmic emulsion
Dosing: One drop in the study eye (and fellow eye, if applicable) twice daily for 84 days.
|
Lifitegrast 5% Ophthalmic Solution
n=54 participants at risk
Eye drop:
Topical, preservative-free lifitegrast 5% ophthalmic solution
Dosing: One drop in the study eye (and fellow eye, if applicable) twice daily for 84 days.
|
|---|---|---|---|---|---|---|---|
|
Eye disorders
Conjuctival hyperaemia, study eye and/or fellow eye
|
5.8%
3/52 • Number of events 4 • From each participant's signature of informed consent at Screening through Day 98 (completion of the study) or early withdrawal, which ever came first.
Adverse events were collected from each participant's signature of informed consent at Screening through Day 98 (completion of the study) or early withdrawal, which ever came first.
|
14.0%
7/50 • Number of events 8 • From each participant's signature of informed consent at Screening through Day 98 (completion of the study) or early withdrawal, which ever came first.
Adverse events were collected from each participant's signature of informed consent at Screening through Day 98 (completion of the study) or early withdrawal, which ever came first.
|
8.0%
4/50 • Number of events 6 • From each participant's signature of informed consent at Screening through Day 98 (completion of the study) or early withdrawal, which ever came first.
Adverse events were collected from each participant's signature of informed consent at Screening through Day 98 (completion of the study) or early withdrawal, which ever came first.
|
6.1%
3/49 • Number of events 4 • From each participant's signature of informed consent at Screening through Day 98 (completion of the study) or early withdrawal, which ever came first.
Adverse events were collected from each participant's signature of informed consent at Screening through Day 98 (completion of the study) or early withdrawal, which ever came first.
|
12.8%
6/47 • Number of events 9 • From each participant's signature of informed consent at Screening through Day 98 (completion of the study) or early withdrawal, which ever came first.
Adverse events were collected from each participant's signature of informed consent at Screening through Day 98 (completion of the study) or early withdrawal, which ever came first.
|
6.4%
3/47 • Number of events 4 • From each participant's signature of informed consent at Screening through Day 98 (completion of the study) or early withdrawal, which ever came first.
Adverse events were collected from each participant's signature of informed consent at Screening through Day 98 (completion of the study) or early withdrawal, which ever came first.
|
0.00%
0/54 • From each participant's signature of informed consent at Screening through Day 98 (completion of the study) or early withdrawal, which ever came first.
Adverse events were collected from each participant's signature of informed consent at Screening through Day 98 (completion of the study) or early withdrawal, which ever came first.
|
|
Eye disorders
Vision blurred, study eye and/or fellow eye
|
0.00%
0/52 • From each participant's signature of informed consent at Screening through Day 98 (completion of the study) or early withdrawal, which ever came first.
Adverse events were collected from each participant's signature of informed consent at Screening through Day 98 (completion of the study) or early withdrawal, which ever came first.
|
0.00%
0/50 • From each participant's signature of informed consent at Screening through Day 98 (completion of the study) or early withdrawal, which ever came first.
Adverse events were collected from each participant's signature of informed consent at Screening through Day 98 (completion of the study) or early withdrawal, which ever came first.
|
0.00%
0/50 • From each participant's signature of informed consent at Screening through Day 98 (completion of the study) or early withdrawal, which ever came first.
Adverse events were collected from each participant's signature of informed consent at Screening through Day 98 (completion of the study) or early withdrawal, which ever came first.
|
0.00%
0/49 • From each participant's signature of informed consent at Screening through Day 98 (completion of the study) or early withdrawal, which ever came first.
Adverse events were collected from each participant's signature of informed consent at Screening through Day 98 (completion of the study) or early withdrawal, which ever came first.
|
0.00%
0/47 • From each participant's signature of informed consent at Screening through Day 98 (completion of the study) or early withdrawal, which ever came first.
Adverse events were collected from each participant's signature of informed consent at Screening through Day 98 (completion of the study) or early withdrawal, which ever came first.
|
0.00%
0/47 • From each participant's signature of informed consent at Screening through Day 98 (completion of the study) or early withdrawal, which ever came first.
Adverse events were collected from each participant's signature of informed consent at Screening through Day 98 (completion of the study) or early withdrawal, which ever came first.
|
18.5%
10/54 • Number of events 12 • From each participant's signature of informed consent at Screening through Day 98 (completion of the study) or early withdrawal, which ever came first.
Adverse events were collected from each participant's signature of informed consent at Screening through Day 98 (completion of the study) or early withdrawal, which ever came first.
|
|
General disorders
Instillation site pain, study eye and/or fellow eye
|
13.5%
7/52 • Number of events 11 • From each participant's signature of informed consent at Screening through Day 98 (completion of the study) or early withdrawal, which ever came first.
Adverse events were collected from each participant's signature of informed consent at Screening through Day 98 (completion of the study) or early withdrawal, which ever came first.
|
6.0%
3/50 • Number of events 4 • From each participant's signature of informed consent at Screening through Day 98 (completion of the study) or early withdrawal, which ever came first.
Adverse events were collected from each participant's signature of informed consent at Screening through Day 98 (completion of the study) or early withdrawal, which ever came first.
|
10.0%
5/50 • Number of events 5 • From each participant's signature of informed consent at Screening through Day 98 (completion of the study) or early withdrawal, which ever came first.
Adverse events were collected from each participant's signature of informed consent at Screening through Day 98 (completion of the study) or early withdrawal, which ever came first.
|
0.00%
0/49 • From each participant's signature of informed consent at Screening through Day 98 (completion of the study) or early withdrawal, which ever came first.
Adverse events were collected from each participant's signature of informed consent at Screening through Day 98 (completion of the study) or early withdrawal, which ever came first.
|
0.00%
0/47 • From each participant's signature of informed consent at Screening through Day 98 (completion of the study) or early withdrawal, which ever came first.
Adverse events were collected from each participant's signature of informed consent at Screening through Day 98 (completion of the study) or early withdrawal, which ever came first.
|
6.4%
3/47 • Number of events 3 • From each participant's signature of informed consent at Screening through Day 98 (completion of the study) or early withdrawal, which ever came first.
Adverse events were collected from each participant's signature of informed consent at Screening through Day 98 (completion of the study) or early withdrawal, which ever came first.
|
18.5%
10/54 • Number of events 10 • From each participant's signature of informed consent at Screening through Day 98 (completion of the study) or early withdrawal, which ever came first.
Adverse events were collected from each participant's signature of informed consent at Screening through Day 98 (completion of the study) or early withdrawal, which ever came first.
|
|
General disorders
Instillation site pruritus, study eye and/or fellow eye
|
0.00%
0/52 • From each participant's signature of informed consent at Screening through Day 98 (completion of the study) or early withdrawal, which ever came first.
Adverse events were collected from each participant's signature of informed consent at Screening through Day 98 (completion of the study) or early withdrawal, which ever came first.
|
0.00%
0/50 • From each participant's signature of informed consent at Screening through Day 98 (completion of the study) or early withdrawal, which ever came first.
Adverse events were collected from each participant's signature of informed consent at Screening through Day 98 (completion of the study) or early withdrawal, which ever came first.
|
0.00%
0/50 • From each participant's signature of informed consent at Screening through Day 98 (completion of the study) or early withdrawal, which ever came first.
Adverse events were collected from each participant's signature of informed consent at Screening through Day 98 (completion of the study) or early withdrawal, which ever came first.
|
0.00%
0/49 • From each participant's signature of informed consent at Screening through Day 98 (completion of the study) or early withdrawal, which ever came first.
Adverse events were collected from each participant's signature of informed consent at Screening through Day 98 (completion of the study) or early withdrawal, which ever came first.
|
0.00%
0/47 • From each participant's signature of informed consent at Screening through Day 98 (completion of the study) or early withdrawal, which ever came first.
Adverse events were collected from each participant's signature of informed consent at Screening through Day 98 (completion of the study) or early withdrawal, which ever came first.
|
0.00%
0/47 • From each participant's signature of informed consent at Screening through Day 98 (completion of the study) or early withdrawal, which ever came first.
Adverse events were collected from each participant's signature of informed consent at Screening through Day 98 (completion of the study) or early withdrawal, which ever came first.
|
5.6%
3/54 • Number of events 3 • From each participant's signature of informed consent at Screening through Day 98 (completion of the study) or early withdrawal, which ever came first.
Adverse events were collected from each participant's signature of informed consent at Screening through Day 98 (completion of the study) or early withdrawal, which ever came first.
|
|
Nervous system disorders
Dysgeusia
|
0.00%
0/52 • From each participant's signature of informed consent at Screening through Day 98 (completion of the study) or early withdrawal, which ever came first.
Adverse events were collected from each participant's signature of informed consent at Screening through Day 98 (completion of the study) or early withdrawal, which ever came first.
|
0.00%
0/50 • From each participant's signature of informed consent at Screening through Day 98 (completion of the study) or early withdrawal, which ever came first.
Adverse events were collected from each participant's signature of informed consent at Screening through Day 98 (completion of the study) or early withdrawal, which ever came first.
|
0.00%
0/50 • From each participant's signature of informed consent at Screening through Day 98 (completion of the study) or early withdrawal, which ever came first.
Adverse events were collected from each participant's signature of informed consent at Screening through Day 98 (completion of the study) or early withdrawal, which ever came first.
|
0.00%
0/49 • From each participant's signature of informed consent at Screening through Day 98 (completion of the study) or early withdrawal, which ever came first.
Adverse events were collected from each participant's signature of informed consent at Screening through Day 98 (completion of the study) or early withdrawal, which ever came first.
|
0.00%
0/47 • From each participant's signature of informed consent at Screening through Day 98 (completion of the study) or early withdrawal, which ever came first.
Adverse events were collected from each participant's signature of informed consent at Screening through Day 98 (completion of the study) or early withdrawal, which ever came first.
|
0.00%
0/47 • From each participant's signature of informed consent at Screening through Day 98 (completion of the study) or early withdrawal, which ever came first.
Adverse events were collected from each participant's signature of informed consent at Screening through Day 98 (completion of the study) or early withdrawal, which ever came first.
|
16.7%
9/54 • Number of events 9 • From each participant's signature of informed consent at Screening through Day 98 (completion of the study) or early withdrawal, which ever came first.
Adverse events were collected from each participant's signature of informed consent at Screening through Day 98 (completion of the study) or early withdrawal, which ever came first.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place