Topical Spironolactone for Dry Eye Syndrome

Recruiting in Palo Alto (17 mi)

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase < 1

Waitlist Available

Sponsor: Richard W Yee, MD

Trial Summary

What is the purpose of this trial?The objective of this study is to evaluate the clinical efficacy of topical spironolactone ophthalmic solution, 0.005 mg/cc in subjects with dry eye disease compared to placebo. The hypothesis for this study is that topical spironolactone ophthalmic solution will be beneficial in the management of signs and symptoms of dry eye disease when compared to placebo.

Eligibility Criteria

This trial is for adults with dry eye disease, confirmed by specific tests. Participants must have good vision and stable eye pressure, not be pregnant or breastfeeding, willing to use birth control if applicable, and able to follow study procedures. They can't join if they've used certain allergy medications or spironolactone recently, had recent eye surgery or infections, unstable systemic diseases, a history of drug/alcohol abuse or severe allergies.

Inclusion Criteria

Patients must meet all Informed Consent requirements

I am of childbearing age and have a negative pregnancy test.

No significant conjunctivochalasis (graded <2 on a 0-4 point scale)

+11 more

Exclusion Criteria

History of drug addiction or alcohol abuse

History of severe systemic or ocular allergy, chronic conjunctivitis, or keratitis other than dry eye

I need eye drops for another eye condition during the study.

+8 more

Participant Groups

The trial is testing the effectiveness of a topical spironolactone ophthalmic solution against a placebo in managing dry eye symptoms. Patients will receive either the active medication or a placebo without knowing which one they are getting to compare results fairly.

2Treatment groups

Experimental Treatment

Placebo Group

Group I: TreatmentExperimental Treatment1 Intervention

Subjects receive topical spironolactone ophthalmic solution, 0.005 mg/cc four times a day for 4 weeks.

Group II: PlaceboPlacebo Group1 Intervention

Subjects receive topical spironolactone vehicle as placebo four times a day for 4 weeks.