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Trial record 62 of 10804 for:    Placebo AND once

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT03025945
Recruitment Status : Completed
First Posted : January 20, 2017
Results First Posted : December 14, 2018
Last Update Posted : December 14, 2018
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment Phase
Cystoid Macular Edema Drug: Nepafenac 0.3% Drug: Saline Solution Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 662 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: Pseudophakic Cystoid Macular Edema Prevention and Risk Factors; Prospective Study With Adjunctive Once Daily Topical Nepafenac 0.3% Versus Placebo
Study Start Date : October 2013
Actual Primary Completion Date : January 2017
Actual Study Completion Date : January 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Edema
Drug Information available for: Nepafenac

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

Primary Outcome Measures :
  1. Post-operative Clinical Findings of Cystoid Macular Edema [ Time Frame: 6 weeks ]
    post-operative macular volume (mm)

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT03025945

Sponsors and Collaborators
Intuor Technologies, Inc.
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Principal Investigator: Sean McCafferty, MD Arizona Eye Consultants

Publications automatically indexed to this study by Identifier (NCT Number):
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Responsible Party: Intuor Technologies, Inc. Identifier: NCT03025945     History of Changes
Other Study ID Numbers: CME and nepafenac 0.3%
First Posted: January 20, 2017    Key Record Dates
Results First Posted: December 14, 2018
Last Update Posted: December 14, 2018
Last Verified: December 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Additional relevant MeSH terms:
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Macular Edema
Macular Degeneration
Retinal Degeneration
Retinal Diseases
Eye Diseases
Pharmaceutical Solutions
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Inflammatory Agents
Antirheumatic Agents