NCT01996839

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

Loteprednol Etabonate Ophthalmic Gel, 0.38% (BID and TID) Versus Vehicle Gel for the Treatment of Ocular Inflammation and Pain Following Cataract Surgery

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 514 (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 ophthalmic gel

Detailed description

The objective of this study is to evaluate the safety and efficacy of loteprednol etabonate ophthalmic gel, 0.38% (BID and TID) for the treatment of postoperative 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	Loteprednol Etabonate Gel (TID)	One drop of LE gel instilled into the study eye three times per day (TID) for 14 days.
DRUG	Vehicle (BID)	One drop of vehicle instilled into the study eye two times per day (BID) for 14 days
DRUG	Vehicle (TID)	One drop of vehicle instilled into the study eye three times per day (TID) for 14 days

Timeline

• Start date: 2013-12-01
• Primary completion: 2014-05-01
• Completion: 2014-07-01
• First posted: 2013-11-27
• Last updated: 2020-09-25
• Results posted: 2020-09-03

Locations

1 site across 1 country: United States