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

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

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 349 (actual)
• Sponsor: Surface Ophthalmics, Inc. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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

• Dry Eye Disease

Interventions

Type	Name	Description
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

Timeline

• Start date: 2021-01-11
• Primary completion: 2022-03-25
• Completion: 2022-03-25
• First posted: 2021-02-02
• Last updated: 2025-05-11
• Results posted: 2025-03-18

Locations

40 sites across 1 country: United States

Regulatory

• FDA-regulated drug study