At a glance
ClinicalIndex Comparison RecordPhase 2Completed· 24 enrolled
Drug / intervention
Testosterone gel 4.5% +1 moredrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
A Pilot Randomized Controlled Trial of Eyelid Androgen Treatment in Dry Eye
Southern California College of Optometry at Marshall B. Ketchum University·interventional·Posted Dec 4, 2023·Updated May 25, 2025
In Brief
A Phase 2 clinical trial evaluating Testosterone gel 4.5% and Vehicle gel for Aqueous Tear Deficiency and Meibomian Gland Dysfunction of Bilateral Eyes (Disorder). Completed, enrolled 24 participants across 1 site.
Detailed Summary
The purpose of this research study is to evaluate the effectiveness and safety of applying androgen sex hormone (i.e., testosterone) gel on the eyelids in the treatment of dry eye patients. Several studies have demonstrated positive treatment effects in dry eye, but few have applied testosterone gels to the eyelids.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesUnited States
Collaborators--
Timeline
Phase 2CompletedFinished
202420252026
Enrollment StartApr 2023
First PostedDec 2023
Primary CompletionApr 2024
Study CompletionMay 2024
TodayJul 2026
First PostedDec 4, 2023
Enrollment StartApr 2, 2023
Primary CompletionApr 30, 2024
Study CompletionMay 30, 2024
TodayJul 2, 2026
Enrollment to primary: 1.1 yearsPosted 2.6 years ago
Interventions
Testosterone gel 4.5%drug
Testosterone gel applied to eyelids twice per day
Vehicle geldrug
Vehicle gel applied to eyelids twice per day