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

NCT ID: NCT03025945

Last Updated: 2018-12-14

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

662 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-10-31

Study Completion Date

2017-01-31

Brief Summary

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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

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Conditions

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Cystoid Macular Edema

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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nepafenac 0.3%

nepafenac 0.3% ophthalmic solution dosed once daily

Group Type EXPERIMENTAL

Nepafenac 0.3%

Intervention Type DRUG

Saline Solution

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

Group Type PLACEBO_COMPARATOR

Saline Solution

Intervention Type DRUG

Interventions

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Nepafenac 0.3%

Intervention Type DRUG

Saline Solution

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Intuor Technologies, Inc.

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Sean McCafferty, MD

Role: PRINCIPAL_INVESTIGATOR

Arizona Eye Consultants

References

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McCafferty S, Harris A, Kew C, Kassm T, Lane L, Levine J, Raven M. Pseudophakic cystoid macular edema prevention and risk factors; prospective study with adjunctive once daily topical nepafenac 0.3% versus placebo. BMC Ophthalmol. 2017 Feb 20;17(1):16. doi: 10.1186/s12886-017-0405-7.

Reference Type DERIVED
PMID: 28219426 (View on PubMed)

Other Identifiers

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CME and nepafenac 0.3%

Identifier Type: -

Identifier Source: org_study_id