Trial · NCT04734197
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
NCT04734197, Phase 2, Completed, Surface Ophthalmics, Inc.; results first posted 2025-03-18
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. 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. Trials, record NCT04734197. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT04734197
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- 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 number
- NCT04734197
- Status
- Completed
- Phases
- Phase 2
- Enrollment
- 349 participants, actual
- Lead sponsor
- Surface Ophthalmics, Inc.
- Conditions
- Dry Eye Disease
- Interventions
SURF-100 (Combination of 0.3% Mycophenolic Acid and 0.01% Betamethasone Sodium Phosphate), Mycophenolic Acid 0.1%, Mycophenolic Acid 0.3%, Betamethasone Sodium Phosphate 0.01%, Placebo Comparator: Vehicle, Cyclosporine 0.05% Ophthalmic Emulsion, Lifitegrast 5% Ophthalmic Solution
- First posted
- 2021-02-02
- Last updated
- 2025-05-11
- Results first posted
- 2025-03-18
Source ClinicalTrials.gov
Registered outcomes3
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | University of North Carolina Dry Eye Management Scale (UNC DEMS) Responder Analysis | Baseline and Day 84 | 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. |
| Secondary | Tear Break Up Time (TBUT), Study Eye | Baseline and Day 84 | The absolute change from baseline in TBUT in the study eye at Day 84. |
| Secondary | Schirmer Tear Test Score, Study Eye | Baseline and Day 84 | The absolute change from baseline in Schirmer tear score in the study eye at Day 84. |
Source ClinicalTrials.gov
Outcomes3
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | University of North Carolina Dry Eye Management Scale (UNC DEMS) Responder Analysis | Baseline and Day 84 | 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. | percentage of responders | NUMBER |
| SECONDARY | Tear Break Up Time (TBUT), Study Eye | Baseline and Day 84 | 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. | seconds | LEAST_SQUARES_MEAN |
| SECONDARY | Schirmer Tear Test Score, Study Eye | Baseline and Day 84 | 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. | millimeters | LEAST_SQUARES_MEAN |
Source ClinicalTrials.gov
Results by group21
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| University of North Carolina Dry Eye Management Scale (UNC DEMS) Responder Analysis | SURF-100 | 65.4 | 95% Confidence Interval 50.9 to 78.0 | percentage of responders | |
| University of North Carolina Dry Eye Management Scale (UNC DEMS) Responder Analysis | Mycophenolic Acid 0.1% | 90.0 | 95% Confidence Interval 78.2 to 96.7 | percentage of responders | |
| University of North Carolina Dry Eye Management Scale (UNC DEMS) Responder Analysis | Mycophenolic Acid 0.3% | 66.0 | 95% Confidence Interval 51.2 to 78.8 | percentage of responders | |
| University of North Carolina Dry Eye Management Scale (UNC DEMS) Responder Analysis | Betamethasone Sodium Phosphate 0.01% | 71.4 | 95% Confidence Interval 56.7 to 83.4 | percentage of responders | |
| University of North Carolina Dry Eye Management Scale (UNC DEMS) Responder Analysis | Placebo Comparator: Vehicle | 80.9 | 95% Confidence Interval 66.7 to 90.9 | percentage of responders | |
| University of North Carolina Dry Eye Management Scale (UNC DEMS) Responder Analysis | Cyclosporine 0.05% Ophthalmic Emulsion | 72.3 | 95% Confidence Interval 57.4 to 84.4 | percentage of responders | |
| University of North Carolina Dry Eye Management Scale (UNC DEMS) Responder Analysis | Lifitegrast 5% Ophthalmic Solution | 57.4 | 95% Confidence Interval 43.2 to 70.8 | percentage of responders | |
| Tear Break Up Time (TBUT), Study Eye | SURF-100 | 1.70 | 95% Confidence Interval 0.52 to 2.88 | seconds | |
| Tear Break Up Time (TBUT), Study Eye | Mycophenolic Acid 0.1% | 1.84 | 95% Confidence Interval 0.68 to 3.00 | seconds | |
| Tear Break Up Time (TBUT), Study Eye | Mycophenolic Acid 0.3% | 1.41 | 95% Confidence Interval 0.21 to 2.60 | seconds |
1 to 10 of 21Source ClinicalTrials.gov
See all 21 results by groupParticipant flow21
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | SURF-100 | 52 | 52 |
| Overall Study | STARTED | Mycophenolic Acid 0.1% | 50 | 50 |
| Overall Study | STARTED | Mycophenolic Acid 0.3% | 50 | 50 |
| Overall Study | STARTED | Betamethasone Sodium Phosphate 0.01% | 49 | 49 |
| Overall Study | STARTED | Placebo Comparator: Vehicle | 47 | 47 |
| Overall Study | STARTED | Cyclosporine 0.05% Ophthalmic Emulsion | 47 | 47 |
| Overall Study | STARTED | Lifitegrast 5% Ophthalmic Solution | 54 | 54 |
| Overall Study | COMPLETED | SURF-100 | 44 | 44 |
| Overall Study | COMPLETED | Mycophenolic Acid 0.1% | 46 | 46 |
| Overall Study | COMPLETED | Mycophenolic Acid 0.3% | 44 | 44 |
1 to 10 of 21Source ClinicalTrials.gov
See all 21 participant flowAdverse events56
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Conjuctival hyperaemia, study eye and/or fellow eye | Eye disorders | SURF-100 | 3 | 52 | 4 |
| other | Conjuctival hyperaemia, study eye and/or fellow eye | Eye disorders | Mycophenolic Acid 0.1% | 7 | 50 | 8 |
| other | Conjuctival hyperaemia, study eye and/or fellow eye | Eye disorders | Mycophenolic Acid 0.3% | 4 | 50 | 6 |
| other | Conjuctival hyperaemia, study eye and/or fellow eye | Eye disorders | Betamethasone Sodium Phosphate 0.01% | 3 | 49 | 4 |
| other | Conjuctival hyperaemia, study eye and/or fellow eye | Eye disorders | Placebo Comparator: Vehicle | 6 | 47 | 9 |
| other | Conjuctival hyperaemia, study eye and/or fellow eye | Eye disorders | Cyclosporine 0.05% Ophthalmic Emulsion | 3 | 47 | 4 |
| other | Conjuctival hyperaemia, study eye and/or fellow eye | Eye disorders | Lifitegrast 5% Ophthalmic Solution | 0 | 54 | 0 |
| other | Vision blurred, study eye and/or fellow eye | Eye disorders | SURF-100 | 0 | 52 | 0 |
| other | Vision blurred, study eye and/or fellow eye | Eye disorders | Mycophenolic Acid 0.1% | 0 | 50 | 0 |
| other | Vision blurred, study eye and/or fellow eye | Eye disorders | Mycophenolic Acid 0.3% | 0 | 50 | 0 |
1 to 10 of 56Source ClinicalTrials.gov
See all 56 adverse eventsAdverse event totals21
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | SURF-100 | 0 | 52 |
| Total, all-cause mortality | Mycophenolic Acid 0.1% | 0 | 50 |
| Total, all-cause mortality | Mycophenolic Acid 0.3% | 0 | 50 |
| Total, all-cause mortality | Betamethasone Sodium Phosphate 0.01% | 0 | 49 |
| Total, all-cause mortality | Placebo Comparator: Vehicle | 0 | 47 |
| Total, all-cause mortality | Cyclosporine 0.05% Ophthalmic Emulsion | 0 | 47 |
| Total, all-cause mortality | Lifitegrast 5% Ophthalmic Solution | 0 | 54 |
| Total, other adverse events | SURF-100 | 10 | 52 |
| Total, other adverse events | Mycophenolic Acid 0.1% | 10 | 50 |
| Total, other adverse events | Mycophenolic Acid 0.3% | 9 | 50 |
1 to 10 of 21Source ClinicalTrials.gov
See all 21 adverse event totalsPapers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT04734197
GET https://conductscience.org/api/trials/v1/NCT04734197/results?page=2