NCT02208297

Loteprednol Etabonate Ophthalmic Gel for the Treatment of Ocular Inflammation and Pain Following Cataract Surgery

Study to Assess Loteprednol Etabonate Ophthalmic Gel, 0.38% Versus Vehicle Gel for the Treatment of Ocular Inflammation and Pain Following Cataract Surgery

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 326 (actual)
• Sponsor: Bausch & Lomb Incorporated · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The objective of this study is to evaluate the safety and efficacy of loteprednol etabonate (LE) ophthalmic gel, 0.38% (BID)

Detailed description

The objective of this study is to evaluate the safety and efficacy of loteprednol etabonate (LE) ophthalmic gel, 0.38% (BID) for the treatment of inflammation and pain following cataract surgery.

Conditions

• Inflammation
• Pain
• Cataract

Interventions

Type	Name	Description
DRUG	Loteprednol Etabonate Gel (BID)	One drop of LE gel instilled into the study eye two times per day (BID) for 14 days
DRUG	Vehicle Gel (BID)	One drop of vehicle gel instilled into the study eye two times per day (BID) for 14 days

Timeline

• Start date: 2014-09-01
• Primary completion: 2015-03-01
• Completion: 2015-03-01
• First posted: 2014-08-05
• Last updated: 2020-09-25
• Results posted: 2020-09-03

Locations

1 site across 1 country: United States