Eyelid Androgen Treatment in Dry Eye

Sponsor

Southern California College of Optometry at Marshall B. Ketchum University (Other)

Overall Status

Recruiting

CT.gov ID

NCT06154200

Collaborator

(none)

Enrollment

Location

Arms

13.9

Anticipated Duration (Months)

1.7

Patients Per Site Per Month

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Aqueous Tear Deficiency Meibomian Gland Dysfunction of Bilateral Eyes (Disorder)	Drug: Testosterone gel 4.5% Drug: Vehicle gel	Phase 2

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.

Study Design

Study Type:

Interventional

Anticipated Enrollment :

24 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Intervention Model Description:

Subjects randomized to either placebo or drugSubjects randomized to either placebo or drug

Masking:

Triple (Participant, Investigator, Outcomes Assessor)

Masking Description:

Double

Primary Purpose:

Treatment

Official Title:

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

Actual Study Start Date :

Apr 2, 2023

Anticipated Primary Completion Date :

May 30, 2024

Anticipated Study Completion Date :

May 30, 2024

Arms and Interventions

Arm	Intervention/Treatment
Placebo Comparator: Vehicle Gel Vehicle gel applied to eyelids twice per day	Drug: Vehicle gel Vehicle gel applied to eyelids twice per day Other Names: placebo
Active Comparator: Testosterone gel 4.5% Testosterone gel 4.5% applied to eyelids twice per day	Drug: Testosterone gel 4.5% Testosterone gel applied to eyelids twice per day Other Names: androgen gel 4.5%

Arm

Intervention/Treatment

Placebo Comparator: Vehicle Gel

Vehicle gel applied to eyelids twice per day

Drug: Vehicle gel

Vehicle gel applied to eyelids twice per day

Other Names:

placebo

Active Comparator: Testosterone gel 4.5%

Testosterone gel 4.5% applied to eyelids twice per day

Drug: Testosterone gel 4.5%

Testosterone gel applied to eyelids twice per day

Other Names:

androgen gel 4.5%

Outcome Measures

Primary Outcome Measures

Fluorescein break up time (TBUT) [From enrollment to two months post treatment]
Time to first dark spot appearance in the tear film

Secondary Outcome Measures

Lower meibomian gland secretion score (0 - 32 scale) [From enrollment to two months post treatment]
8 central lower meibomian glands are evaluated using gentle (vs forceful) expression. Each secretion is given a score of 0 (clear normal meibum), 1 (cloudy low viscosity) 2 (thick, opaque, 3 inspissated or 4 (no secretion visible). One-half scale increments are used.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

Moderate to severe dry eye (TBUT < 6.0 seconds, corneal staining > grade 1.5, evidence of meibomian gland secretion compromise or Schirmer < 5 mm wetting in 5 minutes)
Age over 18
Mild ectropion
Previous contact lens wearers IF no wear for prior 6 months
Punctal plugs if more than three months since placement
Systemic tetracyclines, antihistamines if consistent dosing
Sjogren's syndrome and related autoimmune conditions can be enrolled
Patients using topical dry eye treatments (e.g., Restasis) if willing to discontinue for 30 days