drugset / Trial / 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
RandomizedParallel-groupQuadruple-blindTreatment
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.
Timeline
- Start
- 2021-01-11
- Primary completion
- 2022-03-25
- Completion
- 2022-03-25
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Betamethasone | Other / unclassified | 0.01 % | Topical |
| Comparator | Cyclosporine | Peptide | 0.05 % | Topical |
| Comparator | Lifitegrast | Unknown | 5 % | Topical |
| Subject | mycophenolic acid | Small molecule | 0.1 % | Topical |
| Subject | mycophenolic acid | Small molecule | 0.3 % | Topical |