Trial Outcomes & Findings for Research Study To See How Well An Eye Drop (SURF-200) Works, What Side Effects There Are, And To Compare It With Vehicle In Subjects With An Episodic Flare-Up of Dry Eye Disease (NCT NCT04734210)
NCT ID: NCT04734210
Last Updated: 2025-06-04
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 minimum reduction of ≥1 point in UNC DEMS score from baseline were defined as responders, and response rates were summarized by treatment group.
COMPLETED
PHASE2
139 participants
Baseline and Day 8
2025-06-04
Participant Flow
Study periods: Dosing Days 1-14. Follow-up (FU) to Day 28: Responders continued in the study; non-responders discontinued. Responders had to have a reduction of ≥1 unit in UNC DEMS score and a ≥0.5 point reduction in conjunctival hyperemia grade (study eye) compared to baseline. FU to Day 70 or rebound: Responders were followed up to Day 70 or rebound. Rebound was defined as worsening in UNC DEMS score of ≥1 unit and a worsening in conjunctival hyperemia of ≥0.5 point (study eye).
Prior to each participant's assignment by chance to one of the three 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-200 (0.02% Betamethasone Sodium Phosphate in Vehicle)
Eye Drops: 0.02% Betamethasone Sodium Phosphate (topical corticosteroid solution)
Dosing: One drop twice daily in the study eye for 14 days.
|
SURF-200 (0.04% Betamethasone Sodium Phosphate in Vehicle)
Eye drops: 0.04% Betamethasone Sodium Phosphate (topical corticosteroid solution)
Dosing: One drop twice daily in the study eye for 14 days.
|
Vehicle
Eye drops: Placebo (topical vehicle solution)
Dosing: One drop twice daily in the study eye for 14 days.
|
|---|---|---|---|
|
Two-week Dosing Period (Days 1 - 14)
STARTED
|
47 47
|
45 45
|
47 47
|
|
Two-week Dosing Period (Days 1 - 14)
COMPLETED
|
44 44
|
44 44
|
46 46
|
|
Two-week Dosing Period (Days 1 - 14)
NOT COMPLETED
|
3 3
|
1 1
|
1 1
|
|
Safety Follow-up to Day 28
STARTED
|
44 44
|
44 44
|
46 46
|
|
Safety Follow-up to Day 28
COMPLETED
|
30 30
|
34 34
|
30 30
|
|
Safety Follow-up to Day 28
NOT COMPLETED
|
14 14
|
10 10
|
16 16
|
|
Safety Follow-up to Day 70 or Rebound
STARTED
|
30 30
|
34 34
|
30 30
|
|
Safety Follow-up to Day 70 or Rebound
COMPLETED
|
24 24
|
24 24
|
25 25
|
|
Safety Follow-up to Day 70 or Rebound
NOT COMPLETED
|
6 6
|
10 10
|
5 5
|
Reasons for withdrawal
| Measure |
SURF-200 (0.02% Betamethasone Sodium Phosphate in Vehicle)
Eye Drops: 0.02% Betamethasone Sodium Phosphate (topical corticosteroid solution)
Dosing: One drop twice daily in the study eye for 14 days.
|
SURF-200 (0.04% Betamethasone Sodium Phosphate in Vehicle)
Eye drops: 0.04% Betamethasone Sodium Phosphate (topical corticosteroid solution)
Dosing: One drop twice daily in the study eye for 14 days.
|
Vehicle
Eye drops: Placebo (topical vehicle solution)
Dosing: One drop twice daily in the study eye for 14 days.
|
|---|---|---|---|
|
Two-week Dosing Period (Days 1 - 14)
Withdrawal by Subject
|
1
|
1
|
0
|
|
Two-week Dosing Period (Days 1 - 14)
Protocol Violation
|
1
|
0
|
0
|
|
Two-week Dosing Period (Days 1 - 14)
Did not complete dosing with study drug but remained in the study for safety follow-up at Day 28.
|
1
|
0
|
0
|
|
Two-week Dosing Period (Days 1 - 14)
Did not dose with study drug; missed Day 8 visit and did not return dosing diary. Lost to follow-up.
|
0
|
0
|
1
|
Baseline Characteristics
Research Study To See How Well An Eye Drop (SURF-200) Works, What Side Effects There Are, And To Compare It With Vehicle In Subjects With An Episodic Flare-Up of Dry Eye Disease
Baseline characteristics by cohort
| Measure |
SURF-200 (0.02% Betamethasone Sodium Phosphate in Vehicle)
n=47 Study Eyes
Eye drops: 0.02% Betamethasone Sodium Phosphate (topical corticosteroid solution)
Dosing: One drop twice daily in the study eye for 14 days.
|
SURF-200 (0.04% Betamethasone Sodium Phosphate in Vehicle)
n=45 Study Eyes
Eye drops: 0.04% Betamethasone Sodium Phosphate (topical corticosteroid solution)
Dosing: One drop twice daily in the study eye for 14 days.
|
Vehicle
n=47 Study Eyes
Eye drops: Placebo (topical vehicle solution)
Dosing: One drop twice daily in the study eye for 14 days.
|
Total
n=139 Study Eyes
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
60.0 years
STANDARD_DEVIATION 15.9 • n=5 Participants
|
60.9 years
STANDARD_DEVIATION 14.1 • n=7 Participants
|
59.7 years
STANDARD_DEVIATION 15.3 • n=5 Participants
|
60.2 years
STANDARD_DEVIATION 15.03 • n=4 Participants
|
|
Sex: Female, Male
Female
|
35 Participants
n=5 Participants
|
34 Participants
n=7 Participants
|
37 Participants
n=5 Participants
|
106 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
12 Participants
n=5 Participants
|
11 Participants
n=7 Participants
|
10 Participants
n=5 Participants
|
33 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
14 Participants
n=5 Participants
|
14 Participants
n=7 Participants
|
13 Participants
n=5 Participants
|
41 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
33 Participants
n=5 Participants
|
30 Participants
n=7 Participants
|
32 Participants
n=5 Participants
|
95 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
3 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
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
4 Participants
n=4 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
|
|
Race (NIH/OMB)
Black or African American
|
6 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
14 Participants
n=4 Participants
|
|
Race (NIH/OMB)
White
|
41 Participants
n=5 Participants
|
40 Participants
n=7 Participants
|
39 Participants
n=5 Participants
|
120 Participants
n=4 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
|
University of North Carolina Dry Eye Management Scale (UNC DEMS) Score at Baseline
|
6.9 UNC DEMS units
STANDARD_DEVIATION 1.2 • n=5 Participants
|
7.2 UNC DEMS units
STANDARD_DEVIATION 1.1 • n=7 Participants
|
6.9 UNC DEMS units
STANDARD_DEVIATION 1.2 • n=5 Participants
|
7.0 UNC DEMS units
STANDARD_DEVIATION 1.1 • n=4 Participants
|
|
Conjunctival hyperemia score in study eye at baseline
|
2.2 units on a scale
STANDARD_DEVIATION 0.4 • n=47 Study Eyes
|
2.3 units on a scale
STANDARD_DEVIATION 0.4 • n=45 Study Eyes
|
2.4 units on a scale
STANDARD_DEVIATION 0.4 • n=47 Study Eyes
|
2.3 units on a scale
STANDARD_DEVIATION 0.4 • n=49 Study Eyes
|
PRIMARY outcome
Timeframe: Baseline and Day 8Population: Intent-to-Treat (ITT) Population: included all randomized subjects regardless of whether post-baseline measures were collected, or study drug was received. For the ITT responder analysis, the analysis was conducted based on the observed available data without any imputation for 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 minimum reduction of ≥1 point in UNC DEMS score from baseline were defined as responders, and response rates were summarized by treatment group.
Outcome measures
| Measure |
SURF-200 (0.02% Betamethasone Sodium Phosphate in Vehicle)
n=47 Participants
Eye drops: 0.02% Betamethasone Sodium Phosphate (topical corticosteroid solution)
Dosing: One drop twice daily in the study eye for 14 days.
|
SURF-200 (0.04% Betamethasone Sodium Phosphate in Vehicle)
n=45 Participants
Eye drops: 0.04% Betamethasone Sodium Phosphate (topical corticosteroid solution)
Dosing: One drop twice daily in the study eye for 14 days.
|
Vehicle
n=46 Participants
Eye drops: Placebo (topical vehicle solution)
Dosing: One drop twice daily in the study eye for 14 days.
|
|---|---|---|---|
|
University of North Carolina Dry Eye Management Scale (UNC DEMS) Responder Analysis
|
53.2 percentage of responders
Interval 38.1 to 67.9
|
60.0 percentage of responders
Interval 44.3 to 74.3
|
65.2 percentage of responders
Interval 49.8 to 78.6
|
SECONDARY outcome
Timeframe: Baseline and Day 15Population: Intent-to-Treat (ITT) Population: included all randomized subjects regardless of whether post-baseline measures were collected, or study drug was received. For the ITT responder analysis, the analysis was conducted based on the observed available data without any imputation for 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 minimum reduction of ≥1 point in UNC DEMS score from baseline were defined as responders, and response rates were summarized by treatment group.
Outcome measures
| Measure |
SURF-200 (0.02% Betamethasone Sodium Phosphate in Vehicle)
n=45 Participants
Eye drops: 0.02% Betamethasone Sodium Phosphate (topical corticosteroid solution)
Dosing: One drop twice daily in the study eye for 14 days.
|
SURF-200 (0.04% Betamethasone Sodium Phosphate in Vehicle)
n=44 Participants
Eye drops: 0.04% Betamethasone Sodium Phosphate (topical corticosteroid solution)
Dosing: One drop twice daily in the study eye for 14 days.
|
Vehicle
n=45 Participants
Eye drops: Placebo (topical vehicle solution)
Dosing: One drop twice daily in the study eye for 14 days.
|
|---|---|---|---|
|
University of North Carolina Dry Eye Management Scale (UNC DEMS) Responder Analysis
|
88.9 percentage of responders
Interval 75.9 to 96.3
|
93.2 percentage of responders
Interval 81.3 to 98.6
|
82.2 percentage of responders
Interval 67.9 to 92.0
|
SECONDARY outcome
Timeframe: Baseline and Day 8Population: Intent-to-Treat (ITT) Population: included all randomized subjects regardless of whether post-baseline measures were collected, or study drug was received. For the ITT responder analysis, the analysis was conducted based on the observed available data without any imputation for missing data.
Conjunctival hyperemia was graded by Investigator using the scale below and clinical grade reference photos: Grade 0 (none: no hyperemia of the bulbar conjunctiva) Grade 0.5 (Grade 0 plus dilation of at least a couple of conjunctival blood vessels \[CBVs\] but less than Grade 1) Grade 1 (mild: the dilation of a few CBVs) Grade 1.5 (Grade 1 plus dilation of some CBVs but less than Grade 2) Grade 2 (moderate: the dilation of several CBVs) Grade 2.5 (Grade 2 plus dilation of many CBVs but less than Grade 3) Grade 3 (severe: the abundant and overwhelming dilation of many CBVs) Participants with a minimum reduction of ≥0.5 point in conjunctival hyperemia grade in the study eye from baseline were defined as responders, and response rates were summarized by treatment group.
Outcome measures
| Measure |
SURF-200 (0.02% Betamethasone Sodium Phosphate in Vehicle)
n=47 Participants
Eye drops: 0.02% Betamethasone Sodium Phosphate (topical corticosteroid solution)
Dosing: One drop twice daily in the study eye for 14 days.
|
SURF-200 (0.04% Betamethasone Sodium Phosphate in Vehicle)
n=45 Participants
Eye drops: 0.04% Betamethasone Sodium Phosphate (topical corticosteroid solution)
Dosing: One drop twice daily in the study eye for 14 days.
|
Vehicle
n=46 Participants
Eye drops: Placebo (topical vehicle solution)
Dosing: One drop twice daily in the study eye for 14 days.
|
|---|---|---|---|
|
Conjunctival Hyperemia Responder Analysis
|
38.3 percentage of responders
Interval 24.5 to 53.6
|
62.2 percentage of responders
Interval 46.5 to 76.2
|
37.0 percentage of responders
Interval 23.2 to 52.5
|
Adverse Events
SURF-200 (0.02% Betamethasone Sodium Phosphate in Vehicle)
SURF-200 (0.04% Betamethasone Sodium Phosphate in Vehicle)
Vehicle
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place