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Corticosteroid
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
Phase 2
Waitlist Available
Research Sponsored by Surface Ophthalmics, Inc.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up day 84
Summary
This trial is testing SURF-100 eye drops to see if they can help adults with dry eyes by keeping their eyes moist and reducing discomfort.
Eligible Conditions
- Dry Eye Syndrome
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ day 84
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~day 84
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
UNC DEMS Score
Secondary study objectives
Schirmer Tear Test Score
Tear Break Up Time (TBUT)
Trial Design
7Treatment groups
Experimental Treatment
Active Control
Placebo Group
Group I: SURF-100 (a combination of 0.3% Mycophenolic Acid and 0.01% Betamethasone Sodium Phosphate)Experimental Treatment1 Intervention
One drop in the study eye (and fellow eye, if applicable) twice daily for 84 days
Group II: Mycophenolic Acid 0.3%Experimental Treatment1 Intervention
One drop in the study eye (and fellow eye, if applicable) twice daily for 84 days.
Group III: Mycophenolic Acid 0.1%Experimental Treatment1 Intervention
One drop in the study eye (and fellow eye, if applicable) twice daily for 84 days.
Group IV: Betamethasone Sodium Phosphate 0.01%Experimental Treatment1 Intervention
One drop in the study eye (and fellow eye, if applicable) twice daily for 84 days.
Group V: Cyclosporine 0.05% Ophthalmic EmulsionActive Control1 Intervention
One drop in the study eye (and fellow eye, if applicable) twice daily for 84 days
Group VI: Lifitegrast 5% Ophthalmic SolutionActive Control1 Intervention
One drop in the study eye (and fellow eye, if applicable) twice daily for 84 days
Group VII: VehiclePlacebo Group1 Intervention
One drop in the study eye (and fellow eye, if applicable) twice daily for 84 days.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Betamethasone Sodium Phosphate 0.01%
2021
Completed Phase 2
~360
Mycophenolic Acid 0.1%
2021
Completed Phase 2
~360
Mycophenolic Acid 0.3%
2021
Completed Phase 2
~360
SURF-100 (Combination of 0.3% Mycophenolic Acid and 0.01% Betamethasone Sodium Phosphate)
2021
Completed Phase 2
~360
Find a Location
Who is running the clinical trial?
Surface Ophthalmics, Inc.Lead Sponsor
2 Previous Clinical Trials
230 Total Patients Enrolled
Surface Pharmaceuticals, Inc.Lead Sponsor
2 Previous Clinical Trials
230 Total Patients Enrolled
Kamran Hosseini, MD, PhDStudy ChairSurface Ophthalmics, Inc. (formerly Surface Pharmaceutials, Inc.)
2 Previous Clinical Trials
230 Total Patients Enrolled