Eyelid Androgen Treatment in Dry Eye

NCT ID: NCT06154200

Last Updated: 2025-05-25

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 24 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-04-02
• Study Completion Date: 2024-05-30

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.

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)

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

Vehicle Gel

Vehicle gel applied to eyelids twice per day

Group Type: PLACEBO_COMPARATOR

Vehicle gel

Intervention Type: DRUG

Vehicle gel applied to eyelids twice per day

Testosterone gel 4.5%

Testosterone gel 4.5% applied to eyelids twice per day

Group Type: ACTIVE_COMPARATOR

Testosterone gel 4.5%

Intervention Type: DRUG

Testosterone gel applied to eyelids twice per day

Interventions

Testosterone gel 4.5%

Testosterone gel applied to eyelids twice per day

Intervention Type: DRUG

Vehicle gel

Vehicle gel applied to eyelids twice per day

Intervention Type: DRUG

Other Intervention Names

androgen gel 4.5%; placebo

Eligibility Criteria

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

Exclusion Criteria

• If artificial tears or autologous serum used on day of study
• Ocular surgery if less than 12 months
• Punctal plugs if within 3 months of plug insertion
• Contact Lens wear within the six months prior to study
• PSA levels greater than 4 ng/ml or BPH
• Recent or current thrombolism
• Recent or current cardiovascular events (e.g., MI, stroke)
• Recent or current liver disorders
• Concurrent use of topical medications; e,g., topical glaucoma medications
• Diabetics
• Females of child-bearing age if not on reliable birth control
• History of breast cancer
• Cannot be taking insulin, warfarin or systemic corticosteroids

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Southern California College of Optometry at Marshall B. Ketchum University

OTHER

Sponsor Role: lead

Responsible Party

Jerry Paugh

Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Jerry Paugh, OD, PhD

Role: PRINCIPAL_INVESTIGATOR

SCCO at MBKU

Locations

Southern California College of Optometry at Marshall B. Ketchum University

Fullerton, California, United States

Countries

United States

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Document Type: Informed Consent Form

View Document

Other Identifiers

21-18

Identifier Type: -

Identifier Source: org_study_id