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Corticosteroid
0.02% Betamethasone Sodium Phosphate for Dry Eye Syndrome
Phase 2
Waitlist Available
Research Sponsored by Surface Pharmaceuticals, Inc.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Conjunctival hyperemia score of greater than or equal to 2 in the study eye when using the conjunctival hyperemia reference photos
Schirmer's Tear Test score (with anesthesia) greater than 1 mm but less than or equal to12 mm in the study eye
Timeline
Screening 3 weeks
Treatment Varies
Follow Up day 15
Awards & highlights
Study Summary
This trial is testing a new drug, SURF-200, for people experiencing a flare-up of dry eye disease. The drug is in the form of an eye drop, and the trial will involve 120 participants across the United States.
Eligible Conditions
- Dry Eye Syndrome
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
You have a UNC DEMS score of greater than or equal to 5 but less than or equal to 9.
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Subjects must have a best-corrected visual acuity (BCVA) of at least +1.0 logMAR (Snellen equivalent of 20/200) in the non-study eye (fellow eye).
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Subjects must have an IOP of >8 mmHg and ≤22 mmHg in the study eye.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ day 15
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~day 15
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Secondary outcome measures
Conjunctival Hyperemia Assessment
UNC DEMS Score
Trial Design
3Treatment groups
Experimental Treatment
Placebo Group
Group I: SURF-200 (0.04% betamethasone sodium phosphate in vehicle)Experimental Treatment1 Intervention
One drop BID in the study eye for 14 days.
Group II: SURF-200 (0.02% betamethasone sodium phosphate in vehicle)Experimental Treatment1 Intervention
One drop twice daily (BID) in the study eye for 14 days.
Group III: VehiclePlacebo Group1 Intervention
One drop BID in the study eye for 14 days.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
0.02% Betamethasone Sodium Phosphate
2021
Completed Phase 2
~140
0.04% Betamethasone Sodium Phosphate
2021
Completed Phase 2
~140
Find a Location
Who is running the clinical trial?
Surface Pharmaceuticals, Inc.Lead Sponsor
2 Previous Clinical Trials
442 Total Patients Enrolled
Surface Ophthalmics, Inc.Lead Sponsor
2 Previous Clinical Trials
442 Total Patients Enrolled
Kamran Hosseini, MD, PhDStudy ChairSurface Ophthalmics, Inc. (formerly Surface Pharmaceuticals, Inc.)
2 Previous Clinical Trials
442 Total Patients Enrolled
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Who else is applying?
What state do they live in?
Kentucky
How old are they?
18 - 65
What portion of applicants met pre-screening criteria?
Did not meet criteria
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