NCT05995392

The Effects and Safety of Topical Spironolactone Ophthalmic Solution, 0.005 mg/cc in Subjects With Dry Eye Disease

A Single-Center, Prospective Randomized, Double-Masked, Placebo-Controlled, Parallel- Group Pilot Study of the Effects and Safety of Topical Spironolactone Ophthalmic Solution, 0.005 mg/cc in Subjects With Dry Eye

• Status: Unknown
• Phase: EARLY_Phase 1
• Study type: Interventional
• Enrollment: 30 (estimated)
• Sponsor: Richard W Yee, MD · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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.

Conditions

• Dry Eye Disease

Interventions

Type	Name	Description
DRUG	Topical spironolactone ophthalmic solution, 0.005 mg/cc	Used four times a day in both eyes for 4 weeks.
DRUG	Placebo	Used four times a day in both eyes for 4 weeks.

Timeline

• Start date: 2023-08-01
• Primary completion: 2024-02-01
• Completion: 2024-04-01
• First posted: 2023-08-16
• Last updated: 2023-08-21

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study