The objective of this study is to determine the efficacy and safety of Pimecrolimus 0.3% (MR-139) Ophthalmic Ointment.
The study is designed to evaluate Pimecrolimus 0.3% Ophthalmic Ointment in subjects with blepharitis to complete resolution (score = 0 on grading scale of 0-4) for eyelid debris after BID use at Week 6 in the Study Eye.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
477
Pimecrolimus 0.3% Ophthalmic Ointment will be applied twice a day to both eyelid margins.
Placebo will be applied twice a day to both eyelid margins.
Efficacy of Study Drug
Complete Resolution (score =0 on grading scale 0-4) of eyelid debris. A higher score indicates a worse outcome.
Time frame: 6 weeks
Ocular Discomfort Score
Proportion with at least 50% reduction from baseline in ODS at Week 6. Ocular discomfort is assessed by visual analog scale on a scale from 0-100 where 0 indicates no discomfort and 100 indicates maximum. A higher score indicates a worse outcome.
Time frame: 6 weeks
Collarettes
Proportion of complete resolution for collarettes (score =0 on grading scale 0-4) at Week 6. A higher score indicates a worse outcome.
Time frame: 6 weeks
Eyelid Redness
Proportion of complete resolution (score =0 on grading scale 0-4) for eyelid redness (erythema) at Week 6. A higher score indicates a worse outcome.
Time frame: 6 weeks
Ocular Discomfort Score
The mean change from baseline in ODS at Week 6. Ocular discomfort is assessed by visual analog scale on a scale from 0-100 where 0 indicates no discomfort and 100 indicates maximum. A higher score indicates a worse outcome.
Time frame: 6 weeks
Blepharitis Symptom Measurement
Proportion of complete resolution (score =0 on grading scale of 0-3) for the Eye Irritation Symptom on the BLISS at Week 6. A higher score indicates a worse outcome.
Time frame: 6 weeks
Eyelid Meibum Character
Proportion of complete resolution (score = 0 on grading scale 0-24 for upper lid; 0-15 for lower lid) for eyelid meibum character at Week 6. A higher score indicates a worse outcome.
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Clinical Investigative Site
Pheonix, Arizona, United States
Clinical Investigator Site
Garden Grove, California, United States
Clinical Investigator Site
Glendale, California, United States
Clinical Investigator Site
Inglewood, California, United States
Clinical Investigator Site
Newport Beach, California, United States
Clinical Investigator Site
Petaluma, California, United States
Clinical Investigator Site
Rancho Cordova, California, United States
Clinical Investigator Site
Aurora, Colorado, United States
Clinical Investigator Site
Crystal River, Florida, United States
Clinical Investigator Site
Largo, Florida, United States
...and 19 more locations
Time frame: 6 weeks