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

Primary Purpose

Cystoid Macular Edema

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Nepafenac 0.3%
Saline Solution
Sponsored by
Intuor Technologies, Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Cystoid Macular Edema

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Placebo Comparator

    Arm Label

    nepafenac 0.3%

    Saline Solution

    Arm Description

    nepafenac 0.3% ophthalmic solution dosed once daily

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

    Outcomes

    Primary Outcome Measures

    Post-operative Clinical Findings of Cystoid Macular Edema
    post-operative macular volume (mm)

    Secondary Outcome Measures

    Full Information

    First Posted
    January 14, 2017
    Last Updated
    December 12, 2018
    Sponsor
    Intuor Technologies, Inc.
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    1. Study Identification

    Unique Protocol Identification Number
    NCT03025945
    Brief Title
    Prospective Study With Adjunctive Once Daily Topical Nepafenac 0.3% Versus Placebo
    Official Title
    Pseudophakic Cystoid Macular Edema Prevention and Risk Factors; Prospective Study With Adjunctive Once Daily Topical Nepafenac 0.3% Versus Placebo
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    December 2018
    Overall Recruitment Status
    Completed
    Study Start Date
    October 2013 (undefined)
    Primary Completion Date
    January 2017 (Actual)
    Study Completion Date
    January 2017 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Intuor Technologies, Inc.

    4. Oversight

    Data Monitoring Committee
    No

    5. Study Description

    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Cystoid Macular Edema

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    ParticipantInvestigator
    Allocation
    Randomized
    Enrollment
    662 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    nepafenac 0.3%
    Arm Type
    Experimental
    Arm Description
    nepafenac 0.3% ophthalmic solution dosed once daily
    Arm Title
    Saline Solution
    Arm Type
    Placebo Comparator
    Arm Description
    sterile saline drops with a pH approximately of 7.0 and osmolality of 290 mOsm/kg, dosed at once daily
    Intervention Type
    Drug
    Intervention Name(s)
    Nepafenac 0.3%
    Intervention Type
    Drug
    Intervention Name(s)
    Saline Solution
    Primary Outcome Measure Information:
    Title
    Post-operative Clinical Findings of Cystoid Macular Edema
    Description
    post-operative macular volume (mm)
    Time Frame
    6 weeks

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    No
    Eligibility 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
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Sean McCafferty, MD
    Organizational Affiliation
    Arizona Eye Consultants
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Plan to Share IPD
    No
    Citations:
    PubMed Identifier
    28219426
    Citation
    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.
    Results Reference
    derived

    Learn more about this trial

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

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