Eyelid Androgen Treatment in Dry Eye

NCT06154200 | Completed Phase 2 Results FDA Drug

• 1 other identifier: 21-18
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Keywords

testosterone; fluorescein breakup time; androgen; dry eye

Outcome Measures

Primary Outcomes (1)

• Tear Break up Time

  Time to first dark spot appearance in the tear film

  From baseline to 4 weeks treatment

Secondary Outcomes (1)

• Lower Meibomian Gland Secretion Score (0 - 32 Scale)

  From baseline to 4 weeks treatment

Study Arms (2)

Vehicle Gel

PLACEBO COMPARATOR

Vehicle gel applied to eyelids twice per day

Drug: Vehicle gel

Testosterone gel 4.5%

ACTIVE COMPARATOR

Testosterone gel 4.5% applied to eyelids twice per day

Drug: Testosterone gel 4.5%

Interventions

Testosterone gel 4.5% DRUG

Testosterone gel applied to eyelids twice per day

Also known as: androgen gel 4.5%

Testosterone gel 4.5%

Vehicle gel DRUG

Vehicle gel applied to eyelids twice per day

Also known as: placebo

Vehicle Gel

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Southern California College of Optometry at Marshall B. Ketchum University: lead

Study Sites (1)

Southern California College of Optometry at Marshall B. Ketchum University

Fullerton, California, 92831, United States

Location

MeSH Terms

Conditions

Dry Eye Syndromes

Condition Hierarchy (Ancestors)

Lacrimal Apparatus Diseases; Eye Diseases

Results Point of Contact

• Title: Dr. Jerry Paugh, Professor Emeritus
• Organization: SCCO at MBKU

jpaugh@ketchum.edu

7144497487

Study Officials

• Jerry Paugh, OD, PhD

  SCCO at MBKU

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Double
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Model Details: Subjects randomized to either placebo or drug

Study Record Dates

• First Submitted: November 20, 2023
• First Posted: December 4, 2023
• Study Start: April 2, 2023
• Primary Completion: April 30, 2024
• Study Completion: May 30, 2024
• Last Updated: May 25, 2025
• Results First Posted: May 25, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)