NCT04734210

Research Study To See How Well An Eye Drop (SURF-200) Works, What Side Effects There Are, And To Compare It With Vehicle In Subjects With An Episodic Flare-Up of Dry Eye Disease

A Multicenter, Randomized, Double-Masked, Dose-Ranging Study To Compare The Ocular Safety, Tolerability, And Efficacy Of SURF-200 Ophthalmic Solution (0.02% And 0.04% Betamethasone Sodium Phosphate) To Vehicle In Subjects With A Diagnosis Of Dry Eye Disease And Experiencing An Episodic Flare Up

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 139 (actual)
• Sponsor: Surface Ophthalmics, Inc. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

SURF-200 is being studied in people experiencing an episodic flare-up of their dry eye disease. SURF-200 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-200 works and what side effects there are, and to compare it with vehicle (placebo). The study will involve about 120 study participants at multiple research sites in the United States.

Conditions

• Dry Eye Disease

Interventions

Type	Name	Description
DRUG	0.02% Betamethasone Sodium Phosphate	topical corticosteroid solution
DRUG	0.04% Betamethasone Sodium Phosphate	topical corticosteroid solution
DRUG	Placebo	topical vehicle solution

Timeline

• Start date: 2021-01-07
• Primary completion: 2022-10-12
• Completion: 2022-10-12
• First posted: 2021-02-02
• Last updated: 2025-06-04
• Results posted: 2025-06-04

Locations

28 sites across 1 country: United States

Regulatory

• FDA-regulated drug study