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

December 12, 2018 updated by: Intuor Technologies, Inc.

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

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 Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

662

Phase

  • Not Applicable

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: nepafenac 0.3%
nepafenac 0.3% ophthalmic solution dosed once daily
Drug: Nepafenac 0.3%
Placebo Comparator: Saline Solution
sterile saline drops with a pH approximately of 7.0 and osmolality of 290 mOsm/kg, dosed at once daily
Drug: Saline Solution

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Post-operative Clinical Findings of Cystoid Macular Edema
Time Frame: 6 weeks
post-operative macular volume (mm)
6 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Intuor Technologies, Inc.

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2013

Primary Completion (Actual)

January 1, 2017

Study Completion (Actual)

January 1, 2017

Study Registration Dates

First Submitted

January 14, 2017

First Submitted That Met QC Criteria

January 17, 2017

First Posted (Estimate)

January 20, 2017

Study Record Updates

Last Update Posted (Actual)

December 14, 2018

Last Update Submitted That Met QC Criteria

December 12, 2018

Last Verified

December 1, 2018

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CME and nepafenac 0.3%

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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