Evaluation of Loteprednol Etabonate Versus Vehicle for the Treatment of Inflammation and Pain Following Cataract Surgery
NCT01060072 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 407
Last updated 2012-01-13
Summary
This study is being conducted to compare the safety and efficacy of loteprednol etabonate to vehicle for the treatment of postoperative inflammation and pain following cataract surgery.
Conditions
Interventions
- DRUG
-
Loteprednol etabonate
Topical administration of loteprednol etabonate ophthalmic suspension 1-2 drops in study eye four times a day (QID), postoperative day 1-14.
- DRUG
-
Vehicle of Loteprednol Etabonate
Topical administration of vehicle of loteprednol etabonate ophthalmic suspension 1-2 drops in study eye QID, postoperative day 1-14.
Sponsors & Collaborators
-
Bausch & Lomb Incorporated
lead INDUSTRY
Principal Investigators
-
Laura Trusso · Bausch & Lomb Incorporated
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- DOUBLE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2010-02-28
- Primary Completion
- 2010-09-30
- Completion
- 2010-10-31
Countries
- United States
Study Locations
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