Eyelid Androgen Treatment in Dry Eye

• Status: Recruiting
• Trial end date: 2024-05-30
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Southern California College of Optometry at Marshall B. Ketchum University
• Treatments: Androgens; Testosterone

Criteria

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