Phase 2
N=60
Safety and Efficacy Study of a Testosterone Eye Drop for the Treatment of Meibomian Gland Dysfunction
Meibomian Gland Dysfunction
Bottom Line
View on ClinicalTrials.gov: NCT00755183 ↗Enrolled (actual)
60
Serious AEs
3.3%
Results posted
Oct 2020
Primary outcome: Primary: Meibomian Gland Secretion Appearance at Visit 4 (Day 168) — 0.80; 0.96 units on a scale
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- testosterone ophthalmic solution (Drug); vehicle of testosterone ophthalmic solution (Drug)
- Age
- Adult, Older Adult · 60+ yrs
- Sex
- All
- Sponsor
- ORA, Inc.
- Primary completion
- Apr 2009
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Meibomian Gland Secretion Appearance at Visit 4 (Day 168) |
0.80; 0.96 | — |
| PRIMARY Ocular Discomfort Score at Visit 4 |
1.70; 1.33 | — |
Summary
The objective of this study is to assess the safety and efficacy of testosterone 0.03% ophthalmic solution compared to vehicle for the treatment of meibomian gland dysfunction.
Eligibility Criteria
Inclusion Criteria (subjects must):
- Be ≥ 60 years of age
- Have a corrected visual acuity of LogMAR +0.5 (ETDRS)
- Have a documented history of Meibomian Gland Dysfunction
- Have a TFBUT ≤ 5 seconds
- Have an ocular discomfort score ≥ 1
- Have an IOP ≤ 25 mmHg at Visit 1 in both eyes
- Report use of and/or desire to use an artificial tears
Exclusion Criteria (subjects may not):
- Have contraindications to the use of the study medications
- Have a known allergy or sensitivity to the study medications
- Have any ocular infections, or active ocular inflammation
- Have used ocular medications within 24 hours prior to Visit 1
- Be a current contact lens wearer
- Require the use of any other ophthalmic medication, other than tear substitutes and study medication provided, for the duration of the trial
- Have used systemic or topical antihistamines or steroids 48 hours prior to Visit 1 or require the use of systemic or topical antihistamines or steroids during the course of the study
- Have a history of prostate cancer
Data sourced from ClinicalTrials.gov (NCT00755183). 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.