Phase 2 N=24 Randomized Triple-blind Treatment

Eyelid Androgen Treatment in Dry Eye

Aqueous Tear Deficiency · Meibomian Gland Dysfunction of Bilateral Eyes (Disorder)

Bottom Line

View on ClinicalTrials.gov: NCT06154200 ↗

Enrolled (actual)

Serious AEs

0.0%

Results posted

May 2025

Primary outcome: Primary: Tear Break up Time — 0.0; 2.9 seconds

Study Design & Population

Study type: Interventional
Phase: Phase 2
Interventions: Testosterone gel 4.5% (Drug); Vehicle gel (Drug)
Age: Adult, Older Adult · 18+ yrs
Sex: All
Sponsor: Southern California College of Optometry at Marshall B. Ketchum University
Primary completion: Apr 2024

Outcome Measures

Outcome	Result	p-value
PRIMARY Tear Break up Time	0.0; 2.9	—
SECONDARY Lower Meibomian Gland Secretion Score (0 - 32 Scale)	0.7; 5.5	—

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 Criteria

Moderate to severe dry eye (TBUT 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

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT06154200). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.