Evaluation of Anti-Inflammatory Treatment in Dry Eye Patients
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|ClinicalTrials.gov Identifier: NCT01276223|
Recruitment Status : Completed
First Posted : January 13, 2011
Results First Posted : March 11, 2013
Last Update Posted : March 11, 2013
|Condition or disease||Intervention/treatment||Phase|
|Dry Eye Disease||Drug: Difluprednate 0.05% ophthalmic emulsion Other: Difluprednate vehicle||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||722 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Double (Participant, Investigator)|
|Official Title:||A Multi-Center, Randomized, Double-Masked Evaluation of Anti-Inflammatory Treatment in Patients With Dry Eye|
|Study Start Date :||February 2011|
|Primary Completion Date :||January 2012|
|Study Completion Date :||January 2012|
Difluprednate 0.05% ophthalmic emulsion, 1 drop to the study eye 2 times a day for 4 weeks, followed by 1 drop to the study eye once daily for 1 week to allow for tapering of the steroid exposure.
Drug: Difluprednate 0.05% ophthalmic emulsion
Topical ocular steroid
Other Name: DUREZOL™
Placebo Comparator: Vehicle
Difluprednate vehicle, 1 drop to the study eye 2 times a day for 4 weeks, followed by 1 drop to the study eye once daily for 1 week.
Other: Difluprednate vehicle
Inactive ingredients used as Run-In and placebo comparator
- Mean Change From Baseline (Week 0) in Visual Analog Scale (VAS) Global Ocular Discomfort Score Over 4 Weeks [ Time Frame: Baseline, up to 4 weeks ]A Visual Analog Scale (VAS) was used by the subject to assess ocular discomfort, both frequency and severity, at baseline (pre-treatment) and weekly thereafter for 4 additional weeks. Each scale was 100 millimeters (mm) in length. The VAS score was calculated by measuring the length in mm from the start of the line to the intersection point of the vertical mark made by the subject. The Global Ocular Discomfort Score is a composite of the two VAS scores, ranging from 0 (very mildly) to 100 (very severely uncomfortable).
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01276223
|United States, Texas|
|Contact Alcon Call Center at 1-888-451-3937 for Trial Locations|
|Fort Worth, Texas, United States, 76134|