Eyelid Androgen Treatment in Dry Eye

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

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 Overview

• Status: Recruiting
• Conditions: Aqueous Tear Deficiency; Meibomian Gland Dysfunction of Bilateral Eyes (Disorder)
• Intervention / Treatment: Drug: Vehicle gel; Drug: Testosterone gel 4.5%

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 Type: Interventional
• Enrollment (Estimated): 24
• Phase: Phase 2

Contacts and Locations

• Study Contact: Name: Jerry R Paugh, OD, PhD; Phone Number: 7144497487; Email: jpaugh@ketchum.edu
• Study Contact Backup: Name: Rima Khankan, PhD; Phone Number: 714-992-7831; Email: rkhankan@ketchum.edu

Study Locations

• United States
  • California
    • Fullerton, California, United States, 92831
      • Recruiting
      • Southern California College of Optometry at Marshall B. Ketchum University
      • Contact: Rima Khankan, PhD; Phone Number: 714-992-7831; Email: rkhankan@ketchum.edu
      • Contact: Jerry Paugh, OD, PhD; Phone Number: 714-449-7487; Email: jpaugh@ketchum.edu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / 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%

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Fluorescein break up time (TBUT)	Time to first dark spot appearance in the tear film	From enrollment to two months post treatment

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Southern California College of Optometry at Marshall B. Ketchum University
• Investigators: Principal Investigator: Jerry Paugh, OD, PhD, SCCO at MBKU

Study record dates

Study Major Dates

• Study Start (Actual): April 2, 2023
• Primary Completion (Estimated): May 30, 2024
• Study Completion (Estimated): May 30, 2024

Study Registration Dates

• First Submitted: November 20, 2023
• First Submitted That Met QC Criteria: November 29, 2023
• First Posted (Estimated): December 4, 2023

Study Record Updates

• Last Update Posted (Estimated): December 4, 2023
• Last Update Submitted That Met QC Criteria: November 29, 2023
• Last Verified: November 1, 2023

More Information

Terms related to this study

• Keywords: dry eye; testosterone; androgen; fluorescein breakup time
• Additional Relevant MeSH Terms: Eye Diseases; Lacrimal Apparatus Diseases; Eyelid Diseases; Dry Eye Syndromes; Meibomian Gland Dysfunction; Physiological Effects of Drugs; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Testosterone; Androgens
• Other Study ID Numbers: 21-18

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: Yes