NCT06154200

Eyelid Androgen Treatment in Dry Eye

A Pilot Randomized Controlled Trial of Eyelid Androgen Treatment in Dry Eye

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 24 (actual)
• Sponsor: Southern California College of Optometry at Marshall B. Ketchum University · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed description

The purpose of this study is to examine the safety and efficacy of transdermal eyelid application of testosterone gel along with the length of any beneficial effect following cessation of treatment. Moderate to severe dry eye subjects will be enrolled into a randomized controlled trial with assignment to either an \~ 4.5% FDA-approved androgen gel (Natesto®, Acerus Pharmaceuticals, Mississagua, Canada) or a placebo formulated similar to Natesto® without testosterone. The gel will be applied to both eyelids in the morning and 12 hours later on both eyelids for a 30 day treatment period Subjects will fulfil DEWS II criteria for eligibility and further be classified as moderate or severe based on DEWS II recommendations. A standardized examination involving signs and symptoms of dry eye and monitoring function of the meibomian and lacrimal glands, as well as clinical tear and ocular surface measures, IOP, and serum testosterone levels, at baseline, following 30 days of testosterone application, and at one and two months post-treatment.

Conditions

• Aqueous Tear Deficiency
• Meibomian Gland Dysfunction of Bilateral Eyes (Disorder)

Interventions

Type	Name	Description
DRUG	Testosterone gel 4.5%	Testosterone gel applied to eyelids twice per day
DRUG	Vehicle gel	Vehicle gel applied to eyelids twice per day

Timeline

• Start date: 2023-04-02
• Primary completion: 2024-04-30
• Completion: 2024-05-30
• First posted: 2023-12-04
• Last updated: 2025-05-25
• Results posted: 2025-05-25

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study