Trial | NCT03025945  Report issue

Title

Prospective Study With Adjunctive Once Daily Topical Nepafenac 0.3% Versus Placebo
Pseudophakic Cystoid Macular Edema Prevention and Risk Factors; Prospective Study With Adjunctive Once Daily Topical Nepafenac 0.3% Versus Placebo

  • Phase

    N/A

  • Study Type

    Interventional

  • Study Participants

    662
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.
Study Started
Oct 31
2013
Primary Completion
Jan 31
2017
Study Completion
Jan 31
2017
Results Posted
Dec 14
2018
Last Update
Dec 14
2018

Drug Nepafenac 0.3%

Drug Saline Solution

nepafenac 0.3% Experimental

nepafenac 0.3% ophthalmic solution dosed once daily

Saline Solution Placebo Comparator

sterile saline drops with a pH approximately of 7.0 and osmolality of 290 mOsm/kg, dosed at once daily

Criteria 

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

Summary

Nepafenac 0.3%

Saline Solution

All Events

Event Type Organ System Event Term Nepafenac 0.3% Saline Solution

Post-operative Clinical Findings of Cystoid Macular Edema

post-operative macular volume (mm)

Nepafenac 0.3%

8.85
mm (Mean)
Standard Deviation: 0.13

Nepafenac 0.3%

8.85
mm (Mean)
Standard Deviation: 0.13

Saline Solution

8.95
mm (Mean)
Standard Deviation: 0.18

Saline Solution

8.95
mm (Mean)
Standard Deviation: 0.18

Total

662
Participants

Total

1000
Eyes

Age, Continuous

68.3
years (Mean)
Full Range: 31.0 to 96.0

Macular volume

8.72
mm (Mean)
Standard Deviation: 0.15

Sex: Female, Male

Overall Study

Nepafenac 0.3%

Saline Solution