Clinical trial NCT06154200: Eyelid Androgen Treatment in Dry Eye
Official title: A Pilot Randomized Controlled Trial of Eyelid Androgen Treatment in Dry Eye
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Aqueous Tear Deficiency
Meibomian Gland Dysfunction of Bilateral Eyes (Disorder)
Keywords: testosterone
fluorescein breakup time
androgen
dry eye
Lead sponsor: Southern California College of Optometry at Marshall B. Ketchum University
Sponsor class: OTHER
First posted: 2023-12-04
Enrollment: 24
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Subjects randomized to either placebo or drug
Primary purpose: TREATMENT

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 studies have demonstrated positive treatment effects in dry eye, but few have applied testosterone gels to the eyelids.

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.

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.

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

Primary outcomes:
measure: Tear Break up Time
timeFrame: From baseline to 4 weeks treatment
Secondary outcomes:
measure: Lower Meibomian Gland Secretion Score (0 - 32 Scale)
timeFrame: From baseline to 4 weeks treatment
Other outcomes:
Locations:
city: Fullerton
country: United States
facility: Southern California College of Optometry at Marshall B. Ketchum University
state: California
Study officials:
affiliation: SCCO at MBKU
name: Jerry Paugh, OD, PhD
role: PRINCIPAL_INVESTIGATOR
References: