NCT02752646

Tolerability and Toxicity of Topically Applied Nepafenac 0.3% vs Ketorolac 0.5%

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 200 (actual)
• Sponsor: MDbackline, LLC · Academic / Other
• Sex: All
• Age: 18 Years – 100 Years
• Healthy volunteers: Not accepted

Summary

This study will examine the tolerability and toxicity of topically applied Nepafenac 0.3% vs ketorolac 0.5% among patients undergoing cataract surgery.

Detailed description

This will be a randomized, prospective, controlled, open-label study, comparing the tolerability and toxicity of two commercially available non-steroidal anti-inflammatory eye drops, nepafenac 0.3% and ketorolac 0.5% (generic formulation). The study will involve one eye of each subject. The study will follow good clinical practices (GCP). The primary outcome measure will be tolerability of the study medication as measured by the eye drop comfort survey instrument.

Conditions

• Cataract

Interventions

Type	Name	Description
DRUG	nepafenac 0.3%	Patients in this group will receive nepafenac 0.3% eye drops once daily after cataract surgery.
DRUG	ketorolac	Patients in this group will receive ketorolac 0.5% eye drops four times daily after cataract surgery.

Timeline

• Start date: 2016-04-01
• Primary completion: 2017-03-01
• Completion: 2017-03-01
• First posted: 2016-04-27
• Last updated: 2017-03-07

Locations

2 sites across 1 country: United States