Evaluation of Loteprednol Etabonate Versus Vehicle for the Treatment of Inflammation and Pain Following Cataract Surgery

Phase 3

Completed

• Conditions: Inflammation; Pain
• Interventions: Drug: Vehicle of Loteprednol Etabonate; Drug: Loteprednol etabonate

• Registration Number: NCT01060072
• Lead Sponsor: Bausch & Lomb Incorporated

Brief 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2010-01-29
• Study Start: 2010-02
• Study First Submitted QC: 2010-02-01
• Study First Posted: 2010-02-02
• Primary Completion: 2010-09
• Study Completion: 2010-10
• Results First Submitted: 2011-09-20
• Status Verified: 2011-12
• Results First Submitted QC: 2011-12-08
• Last Update Submitted: 2011-12-08
• Results First Posted: 2012-01-13
• Last Update Posted: 2012-01-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 407

Inclusion Criteria

• Subjects who are at least 18 years of age.
• Subjects who are candidates for routine, uncomplicated cataract surgery.

Exclusion Criteria

• Subjects who have known hypersensitivity or contraindication to the study drug or components.
• Subjects with a severe/serious ocular condition, or any other unstable medical condition, that in the investigator's opinion may preclude study treatment or follow-up.
• Subjects with elevated intraocular pressure (>/=21mm Hg), uncontrolled glaucoma, or being treated for glaucoma in the study eye.
• Subjects who are monocular or have pinholed Snellen visual acuity (VA) 20/200 or worse in the non-study eye.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Vehicle	Vehicle of Loteprednol Etabonate	Vehicle of loteprednol etabonate ophthalmic suspension
Loteprednol etabonate	Loteprednol etabonate	Loteprednol etabonate 0.5% ophthalmic suspension

Primary Outcome Measures

Name	Time	Method
Resolution of Anterior Chamber Cells.	Visit 5 (Postoperative day 8)	Participants with complete resolution of anterior chamber cells(ACC). Cells were graded on a 0-4 scale, where 0=no cells and 4=\>30 cells
Grade 0 Pain	Visit 5 (Postoperative day 8)	Participants with no pain, graded on a 0-5 scale, 0=no pain and 5=severe pain

Secondary Outcome Measures

Name	Time	Method
Resolution of Anterior Chamber Cells	Visit 4-7 (postoperative day 3-18)	Participants with complete resolution of anterior chamber cells(ACC). Cells were graded on a 0-4 scale, where 0=no cells and 4=\>30 cells
Grade 0 Pain	Visits 4-7 (Postoperative days 3-18)	Participants with no pain, graded on a 0-5 scale, 0= no pain and 5=severe pain
Resolution of Anterior Chamber Flare	Visit 4-7 (postoperative day 3-18)	Complete resolution of flare, scored on a scale of 0-4 were 0=none and 4=very severe.

Trial Locations

Locations (1)

Bausch & Lomb; 🇺🇸 Rochester, New York, United States