Eyelid Androgen Treatment in Dry Eye

Last updated: November 29, 2023
Sponsor: Southern California College of Optometry at Marshall B. Ketchum University
Overall Status: Active - Recruiting

Phase

2

Condition

Dry Eyes

Eyelid Inflammation

Blepharitis

Treatment

Vehicle gel

Testosterone gel 4.5%

Clinical Study ID

NCT06154200
21-18
  • Ages > 18
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Moderate to severe dry eye (TBUT < 6.0 seconds, corneal staining > grade 1.5, evidenceof 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 discontinuefor 30 days

Exclusion

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 Design

Total Participants: 24
Treatment Group(s): 2
Primary Treatment: Vehicle gel
Phase: 2
Study Start date:
April 02, 2023
Estimated Completion Date:
May 30, 2024

Study 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.

Connect with a study center

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

    Fullerton, California 92831
    United States

    Active - Recruiting

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