Prospective Study With Adjunctive Once Daily Topical Nepafenac 0.3% Versus Placebo

Not Applicable

Completed

• Conditions: Cystoid Macular Edema
• Interventions: Drug: Nepafenac 0.3%; Drug: Saline Solution

• Registration Number: NCT03025945
• Lead Sponsor: Intuor Technologies, Inc.

Brief Summary

Prospective, randomized, double-masked, placebo-controlled clinical study to define the effective use of a topical non-steroidal anti-inflammatory drug added to topical steroid use after uncomplicated phacoemulsification for the prevention of pseudophakic cystoid macular edema.

Detailed Description

Not available

Study Timeline

• Study Start: 2013-10
• Primary Completion: 2017-01
• Study Completion: 2017-01
• Study First Submitted: 2017-01-14
• Study First Submitted QC: 2017-01-17
• Study First Posted: 2017-01-20
• Results First Submitted: 2018-10-02
• Status Verified: 2018-12
• Results First Submitted QC: 2018-12-12
• Last Update Submitted: 2018-12-12
• Results First Posted: 2018-12-14
• Last Update Posted: 2018-12-14

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 662

Inclusion Criteria

• Subjects, 18 and older subjects with visually significant cataracts and were to undergo phacoemulsification with implantation of an intracapsular positioned intraocular lens.

Exclusion Criteria

• previous uveitis (<1 year) previous anterior segment intraocular surgery hypersensitivity or allergy to NSAIDs

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
nepafenac 0.3%	Nepafenac 0.3%	nepafenac 0.3% ophthalmic solution dosed once daily
Saline Solution	Saline Solution	sterile saline drops with a pH approximately of 7.0 and osmolality of 290 mOsm/kg, dosed at once daily

Primary Outcome Measures

Name	Time	Method
Post-operative Clinical Findings of Cystoid Macular Edema	6 weeks	post-operative macular volume (mm)