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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 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 349

Last updated 2025-05-11

Study results available
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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

Interventions

DRUG

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

combination of a topical immunosuppressant and a topical corticosteroid solution

DRUG

Mycophenolic Acid 0.1%

topical immunosuppressant

DRUG

Mycophenolic Acid 0.3%

topical immunosuppressant

DRUG

Betamethasone Sodium Phosphate 0.01%

topical corticosteroid solution

DRUG

Placebo Comparator: Vehicle

topical vehicle solution

DRUG

Cyclosporine 0.05% Ophthalmic Emulsion

topical ophthalmic emulsion

DRUG

Lifitegrast 5% Ophthalmic Solution

topical ophthalmic solution

Sponsors & Collaborators

  • Surface Ophthalmics, Inc.

    lead INDUSTRY

Principal Investigators

  • Kamran Hosseini, MD, PhD · Surface Ophthalmics, Inc. (formerly Surface Pharmaceutials, Inc.)

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-01-11
Primary Completion
2022-03-25
Completion
2022-03-25
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04734197 on ClinicalTrials.gov