Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
NCT04734197 · ClinicalTrials.gov registry record · Phase 2
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
A Phase 2 study of Dry Eye Disease, sponsored by Surface Ophthalmics.
- Completed
- Registry status
- Phase 2
- Development phase
- 349
- Enrollment target
- 20
- Study locations
NCT04734197: Completed Phase 2 study of Dry Eye Disease, sponsored by Surface Ophthalmics.
NCT04734197 is a Phase 2 study of Dry Eye Disease that has completed, run by Surface Ophthalmics. The registered enrollment target is 349 participants, above the 244-participant average among 33 other Dry Eye Disease trials with a reported enrollment target (43% higher). The trial reports 20 study locations across 8 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04734197, a Phase 2 study of Dry Eye Disease, has completed, sponsored by Surface Ophthalmics.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 349 participants
- Enrollment target
- 20
- Study locations
Study Summary
SURF-100 is being studied for the treatment of dry eye disease. SURF-100 is an investigational drug (which means the study drug is currently being tested) in the form of a sterile eye drop. The purpose of this research study is to see how well SURF-100 works to treat dry eye and what potential side effects there are, and to compare it with Vehicle (placebo), 0.1% mycophenolic acid (MPA) in Vehicle, 0.3% MPA in Vehicle, 0.01% betamethasone phosphate (BSP) in Vehicle, Restasis and Xiidra. This study will involve about 280-350 study participants age 18 and older at about 40 different research sites in the United States.
Primary Outcome
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.
Conditions Studied
Interventions
- DRUG SURF-100 (Combination of 0.3% Mycophenolic Acid and 0.01% Betamethasone Sodium Phosphate)
- DRUG Mycophenolic Acid 0.1%
- DRUG Mycophenolic Acid 0.3%
- DRUG Betamethasone Sodium Phosphate 0.01%
- DRUG Placebo Comparator: Vehicle
Study Locations (20)
California
- Canyon City EyeCare - Azusa
- Inland Eye Specialists - Hemet
- North Valley Eye Medical Group Inc. - Mission Hills
- LoBue Laser and Eye Medical Center - Murrieta
- Eye Research Foundation - Newport Beach
- Martel Eye Medical Group - Rancho Cordova
- Sacramento Eye Consultants, A Medical Corporation - Sacramento
Florida
- Florida Eye Microsurgical Institute, Inc. - Boynton Beach
- Hernando Eye Institute - Brooksville
- Bowden Eye and Associates - Jacksonville
- Eye Center of North Florida PA - Panama City
- International Research Center - Tampa
- Blue Ocean Clinical Research at The Macula Center - The Villages
Kentucky
- Cincinnati Eye Institute - Edgewood
- Kentucky Eye Institute - Lexington
Arizona
- Cornea and Cataract Consultants of Arizona PC - Phoenix
Colorado
- The Eye Center of Northern Colorado - Fort Collins
Connecticut
- Connecticut Eye Consultants, PC - Danbury
Georgia
- Coastal Research Associates, LLC - Roswell
Illinois
- Jackson Eye - Lake Villa
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 349 participants |
| Start Date | 2021-01-11 |
| Est. Completion | 2022-03-25 |
| Phase | Phase 2 |
What the finished NCT04734197 record still lists
NCT04734197 is an interventional study that assigns participants to a tested intervention. The registered 349 participants enrollment target is mid-sized for trials with a published cap, above the 244-participant average among 33 other Dry Eye Disease trials with a reported enrollment target (43% higher).
The record links to 1 condition, with Dry Eye Disease appearing as the primary indexed condition, and to 5 interventions - of which SURF-100 (Combination of 0.3% Mycophenolic Acid and 0.01% Betamethasone Sodium Phosphate) is the first listed.
NCT04734197 names 20 study sites across 8 states, led by California, Florida, Kentucky.
Frequently Asked Questions
What is clinical trial NCT04734197 about?
NCT04734197 is a clinical study titled "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". SURF-100 is being studied for the treatment of dry eye disease. SURF-100 is an investigational drug (which means the study drug is currently being tested) in the form of a sterile eye drop. The purpose of this research study is to see how well SURF-100 works to treat dry eye and what potential side...
What is the current status of trial NCT04734197?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 349 participants. The study started on 2021-01-11. Estimated completion is 2022-03-25.
What conditions does trial NCT04734197 study?
This clinical trial studies the following conditions: Dry Eye Disease.
What interventions are being tested in trial NCT04734197?
The interventions under investigation include: SURF-100 (Combination of 0.3% Mycophenolic Acid and 0.01% Betamethasone Sodium Phosphate) (DRUG), Mycophenolic Acid 0.1% (DRUG), Mycophenolic Acid 0.3% (DRUG), Betamethasone Sodium Phosphate 0.01% (DRUG), Placebo Comparator: Vehicle (DRUG).
Who is sponsoring clinical trial NCT04734197?
This trial is sponsored by Surface Ophthalmics, which has 3 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT04734197 being conducted?
This trial has 20 study locations across Arizona, California, Colorado, Connecticut, Florida. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Dry Eye Disease
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT04734197's enrollment target sits among peer trials
349 8th of 33 higher than 26 of 33 other Dry Eye Disease trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Dry Eye Disease trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
-
Evaluating the Safety, Tolerability, and Efficacy of GRF312 5% in Participants With Dry Eye Disease (DED).
RECRUITING · Phase 2
-
A Study Evaluating the Safety and Efficacy of a Fixed-Dose Combination for Dry Eye Disease
RECRUITING · Phase 2
-
Phase 2b Controlled Study
ACTIVE NOT RECRUITING · Phase 2
-
A Study of TL-925 Ophthalmic Emulsion as a Treatment for Dry Eye Disease
ACTIVE NOT RECRUITING · Phase 2
-
The Study Evaluating the Efficacy and Safety of OK-101 in Subjects With Dry Eye Disease
COMPLETED · Phase 2
-
Efficacy Study of Ecabet Ophthalmic Solution in Dry Eye Disease
COMPLETED · Phase 2
Nationwide trials with similar profiles
Cross-condition peers matched on enrollment target and registry start date, not the same-condition list above.
Similar enrollment target
- NCT00900575 · 350 participants · NA
Cervical Cancer Detection Using Optical Spectroscopy
- NCT01627821 · 350 participants · NA
Evaluation of the Jarvik 2000 Left Ventricular Assist System With Post-Auricular Connector--Destination Therapy Study
- NCT02357654 · 350 participants · Phase 4
GnRH for Luteal Support in IVF/ICSI/FET Cycles
- NCT03997370 · 350 participants · Phase 1
Evaluation of Dosing Procedures of Chemotherapy Treatment (Carboplatin) With the Contrast Agent Iohexol
Similar registry start date
- NCT05962346 · started 2026-12 · NA
Fetal Endoscopic Tracheal Occlusion for Congenital Diaphragmatic Hernia
- NCT07125183 · started 2026-12 · Phase 2
Study on Efficacy and Tolerability of Weekly Doxorubicin in Elderly Patients With Advanced or Metastatic Leiomyosarcoma
- NCT07292298 · started 2026-11 · Phase 2
Phase 2 Single-Arm Rectal Cancer Brachytherapy for Patients With Low-Lying Residual Adenocarcinoma After Total Neoadjuvant Therapy to Improve Organ Preservation Rates
- NCT04263285 · started 2026-10 · NA
Treatment of Depression Post-SCI