CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 349 enrolled
Drug / intervention
SURF-100 (Combination of 0.3% Mycophenolic Acid and 0.01% Betamethasone Sodium Phosphate) +6 moredrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT04734197
NCT04734197Phase 2Completed
CompareCT.gov

A Multicenter, Randomized, Double-Masked Study To Evaluate The Safety, Tolerability, And Efficacy Of SURF-100 Ophthalmic Solution (A Mycophenolic Acid/Betamethasone Sodium Phosphate Combination) In Subjects With Dry Eye Disease

Surface Ophthalmics, Inc.·interventional·Posted Feb 2, 2021·Updated May 11, 2025

In Brief

A Phase 2 clinical trial evaluating SURF-100 (Combination of 0.3% Mycophenolic Acid and 0.01% Betamethasone Sodium Phosphate), Mycophenolic Acid 0.1%, and 5 other interventions for Dry Eye Disease. Completed, enrolled 349 participants across 40 sites.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsDry Eye Disease
CountriesUnited States
Collaborators--

Timeline

Phase 2CompletedFinished
202120222023202420252026
First PostedFeb 2, 2021
Enrollment StartJan 11, 2021
Primary CompletionMar 25, 2022
TodayJul 2, 2026
Enrollment to primary: 1.2 yearsPosted 5.4 years ago

Interventions

SURF-100 (Combination of 0.3% Mycophenolic Acid and 0.01% Betamethasone Sodium Phosphate)drug

combination of a topical immunosuppressant and a topical corticosteroid solution

Mycophenolic Acid 0.1%drug

topical immunosuppressant

Mycophenolic Acid 0.3%drug

topical immunosuppressant

Betamethasone Sodium Phosphate 0.01%drug

topical corticosteroid solution

Placebo Comparator: Vehicledrug

topical vehicle solution

Cyclosporine 0.05% Ophthalmic Emulsiondrug

topical ophthalmic emulsion

Lifitegrast 5% Ophthalmic Solutiondrug

topical ophthalmic solution