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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 · View on ClinicalTrials.gov ↗
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.
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT04734197
The ClinicalTrials.gov registry entry for NCT04734197 describes a study currently listed as completed. It is categorized as Phase 2, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 349 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Surface Ophthalmics, which has 1 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.
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. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.
Geographic footprint matters for practical reasons: NCT04734197 reports 20 study locations spanning 8 distinct geographic areas — top geographies include California, Florida, Kentucky. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.
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. These conditions were identified from the trial registry and reflect the primary focus areas of the research.
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). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT04734197?
This trial is sponsored by Surface Ophthalmics, which has 1 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.
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.
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