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: NCT01010633
• Lead Sponsor: Bausch & Lomb Incorporated

Brief Summary

This study is being conducted to compare the safety and efficacy of loteprednol etabonate compared to vehicle for the treatment of postoperative inflammation and pain following cataract surgery.

Detailed Description

Not available

Study Timeline

• Study Start: 2009-11
• Study First Submitted: 2009-11-06
• Study First Submitted QC: 2009-11-09
• Study First Posted: 2009-11-10
• Primary Completion: 2010-06
• Study Completion: 2010-08
• Results First Submitted: 2011-08-30
• Status Verified: 2011-12
• Results First Submitted QC: 2011-12-08
• Last Update Submitted: 2011-12-08
• Results First Posted: 2012-01-09
• Last Update Posted: 2012-01-09

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 406

Inclusion Criteria

• Subjects who are at least 18 years of age.
• Subjects who are candidates for routine, uncomplicated cataract surgery.
• Subjects who, in the Investigator's opinion, have potential postoperative pinholed Snellen visual acuity (VA) of at least 20/200 in the study eye.

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 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
Loteprednol Etabonate	Loteprednol Etabonate	Loteprednol etabonate

Primary Outcome Measures

Name	Time	Method
Resolution of Anterior Chamber Cells (ACC).	Visit 5 (Postoperative day 8)	Number of Study eyes with complete resolution(Grade 0) of anterior chamber cells (ACC) for loteprednol and vehicle. Accumulation of white cells in aqueous graded on a scale of 0-4 where grade 0=no cells. Investigators assessed ACC using a slit lamp.
Grade 0 Pain	Visit 5 (Postoperative Day 8)	Number of eyes with grade 0 ocular pain. Ocular pain, defined as a positive sensation of the eye, based on a 0-5 scale where grade 0 equaled no pain and grade 5 equaled severe pain. Ocular pain graded by participants.

Secondary Outcome Measures

Name	Time	Method
Resolution of Anterior Chamber Cells.	At visits 4-7- postoperative day 3, 8,15 & 18	Study eyes with complete resolution of anterior chamber cells (ACC)

Trial Locations

Locations (1)

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