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Clinical trial

A Pilot Randomized Controlled Trial of Eyelid Androgen Treatment in Dry Eye

ID
Name
21-18
Description
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.
Trial arms
Trial start
2023-04-02
Estimated PCD
2024-05-30
Trial end
2024-05-30
Status
Recruiting
Phase
Early phase I
Treatment
Testosterone gel 4.5%
Testosterone gel applied to eyelids twice per day
Arms:
Testosterone gel 4.5%
Other names:
androgen gel 4.5%
Vehicle gel
Vehicle gel applied to eyelids twice per day
Arms:
Vehicle Gel
Other names:
placebo
Size
24
Primary endpoint
Fluorescein break up time (TBUT)
From enrollment to two months post treatment
Eligibility 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
Protocol
{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE2'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Subjects randomized to either placebo or drug', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'TRIPLE', 'maskingDescription': 'Double', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}}, 'enrollmentInfo': {'count': 24, 'type': 'ESTIMATED'}}
Updated at
2023-12-04

1 organization

2 products

2 indications

Organization
Southern California College of Optometry at Marshall B. Ketchum University
Product
Testosterone gel
Indication
Dry Eye Syndrome
Indication
Meibomian Gland Dysfunction
Product
Vehicle gel