Status:
COMPLETED
Eyelid Androgen Treatment in Dry Eye
Lead Sponsor:
Southern California College of Optometry at Marshall B. Ketchum University
Conditions:
Aqueous Tear Deficiency
Meibomian Gland Dysfunction of Bilateral Eyes (Disorder)
Eligibility:
All Genders
18+ years
Phase:
PHASE2
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 st...
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. ...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
April 2 2023
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 30 2024
Estimated Enrollment :
24 Patients enrolled
Trial Details
Trial ID
NCT06154200
Start Date
April 2 2023
End Date
May 30 2024
Last Update
May 25 2025
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Southern California College of Optometry at Marshall B. Ketchum University
Fullerton, California, United States, 92831