Eyelid Androgen Treatment in Dry Eye

Aqueous Tear Deficiency Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06154200
• Other study ID #: 21-18
• Status: Recruiting
• Phase: Phase 2
• Start date: April 2, 2023
• Est. completion date: May 30, 2024

Study information

• Verified date: November 2023
• Source: Southern California College of Optometry at Marshall B. Ketchum University
• Contact: Jerry R Paugh, OD, PhD
• Phone: 7144497487
• Email: jpaugh[@]ketchum.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 24
• Est. completion date: May 30, 2024
• Est. primary completion date: May 30, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Aqueous Tear Deficiency
• Dry Eye Syndromes
• Meibomian Gland Dysfunction

Intervention

Drug:
• Testosterone gel 4.5%
Testosterone gel applied to eyelids twice per day
• Vehicle gel
Vehicle gel applied to eyelids twice per day

Locations

Country	Name	City	State
United States	Southern California College of Optometry at Marshall B. Ketchum University	Fullerton	California

Sponsors (1)

Lead Sponsor	Collaborator
Southern California College of Optometry at Marshall B. Ketchum University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Fluorescein break up time (TBUT)	Time to first dark spot appearance in the tear film	From enrollment to two months post treatment
Secondary	Lower meibomian gland secretion score (0 - 32 scale)	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.	From enrollment to two months post treatment