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Eyelid Androgen Treatment in Dry Eye

NCT06154200 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 24

Last updated 2025-05-25

Study results available
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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)

Interventions

DRUG

Testosterone gel 4.5%

Testosterone gel applied to eyelids twice per day

DRUG

Vehicle gel

Vehicle gel applied to eyelids twice per day

Sponsors & Collaborators

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

    lead OTHER

Principal Investigators

  • Jerry Paugh, OD, PhD · SCCO at MBKU

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-04-02
Primary Completion
2024-04-30
Completion
2024-05-30
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06154200 on ClinicalTrials.gov