Phase 2
N=232
A Study of AGN-195263 for the Treatment of Meibomian Gland Dysfunction
Meibomian Gland Dysfunction
Bottom Line
View on ClinicalTrials.gov: NCT01633788 ↗Enrolled (actual)
232
Serious AEs
3.5%
Results posted
Sep 2017
Primary outcome: Primary: Percentage of Meibum Quality Responders in the Study Eye — 46.3; 33.9; 32.1; 42.9 Percentage of Patients
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- AGN-195263 0.1% (Drug); AGN-195263 0.03% (Drug); AGN-195263 0.01% (Drug); AGN-195263 Vehicle (Drug)
- Age
- Adult, Older Adult · 40+ yrs
- Sex
- All
- Sponsor
- Allergan
- Primary completion
- Feb 2015
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage of Meibum Quality Responders in the Study Eye |
46.3; 33.9; 32.1; 42.9 | — |
| SECONDARY Percentage of Maximum Meibum Quality Score (MMQS) Responders in the Study Eye |
20.4; 23.2; 15.1; 22.4 | — |
| SECONDARY Percentage of Complete Overall Ocular Discomfort Responders |
20.0; 19.6; 14.8; 9.8 | — |
Summary
This study will evaluate the safety and efficacy of AGN-195263 compared to vehicle in patients with meibomian gland dysfunction (MGD) in the eyelids.
Eligibility Criteria
Inclusion Criteria
- Meibomian gland dysfunction in both eyes
- Best-corrected visual acuity of 20/40 or better in each eye
Exclusion Criteria
- Known or suspected prostate cancer
- History of breast cancer
- Using LATISSE® or any other eye lash growth-stimulating product at least 30 days prior to the screening visit, or anticipated use during the study
- Contact lens wear in either eye during any portion of the study
- Unable to instill eye drops correctly
- History of corneal refractive surgery in either eye within 1 year
Data sourced from ClinicalTrials.gov (NCT01633788). 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.