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Trial record 22 of 25 for:    "Lens Disease" | "Nepafenac"

Nepafenac Once Daily for Macular Edema - Study 1

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ClinicalTrials.gov Identifier: NCT01853072
Recruitment Status : Completed
First Posted : May 14, 2013
Results First Posted : August 3, 2016
Last Update Posted : August 3, 2016
Sponsor:
Information provided by (Responsible Party):
Alcon Research

Tracking Information
First Submitted Date  ICMJE May 10, 2013
First Posted Date  ICMJE May 14, 2013
Results First Submitted Date  ICMJE May 13, 2016
Results First Posted Date  ICMJE August 3, 2016
Last Update Posted Date August 3, 2016
Study Start Date  ICMJE June 2013
Actual Primary Completion Date May 2015   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: June 23, 2016)
  • Percentage of Participants With Best-corrected Visual Acuity (BCVA) Improvement of ≥ 15 Letters From Preoperative Baseline to Day 14 and Maintained Through Day 90 [ Time Frame: Baseline to Day 14, and maintained through Day 90 ]
    BCVA (with spectacles or other visual corrective devices) was reported in letters read correctly, using the Early Treatment Diabetic Retinopathy Study (ETDRS) test of 70 letters. Improvement of BCVA was defined as an increase (gain) in the number of letters read, compared to the baseline assessment. One eye (study eye) contributed to the analysis.
  • Percentage of Participants Who Develop Macular Edema Within 90 Days Following Cataract Surgery (Day 0) [ Time Frame: Day 0 to Day 90 ]
    Macular edema was defined as ≥ 30% Increase from pre-operative baseline in central subfield macular thickness, as measured with Spectral Domain Ocular Coherence Tomography (SD-OCT). One eye (study eye) contributed to the analysis.
Original Primary Outcome Measures  ICMJE
 (submitted: May 10, 2013)
Proportion of subjects with BCVA improvement of ≥ 15 letters from preoperative baseline to Day 14 and maintained through Day 90 [ Time Frame: Baseline, up to Day 90 ]
As measured with Early Treatment of Diabetic Retinopathy Study (ETDRS) visual acuity charts
Change History Complete list of historical versions of study NCT01853072 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: June 23, 2016)
  • Percentage of Participants With BCVA Improvement of ≥ 15 Letters From Preoperative Baseline to Day 90 [ Time Frame: Baseline to Day 90 ]
  • Percentage of Participants With BCVA Improvement of ≥ 15 Letters From Preoperative Baseline to Day 60 [ Time Frame: Baseline to Day 60 ]
  • Percentage of Participants With a > 5-letter Loss in BCVA From Day 7 to Any Visit [Time Frame: Day 7 up to Any Visit] [ Time Frame: Day 7 up to any visit through Day 90 ]
  • Percentage of Participants With With a > 10-letter Loss in BCVA From Day 7 to Any Visit [ Time Frame: Day 7 up to any visit through Day 90 ]
Original Secondary Outcome Measures  ICMJE
 (submitted: May 10, 2013)
  • Proportion of subjects who develop macular edema (defined as ≥ 30% increase from pre-operative baseline in central subfield macular thickness) within 90 days following cataract surgery [ Time Frame: Baseline, up to Day 90 ]
    As measured with Spectral Domain Ocular Coherence Tomography (SD-OCT)
  • Proportion of subjects with BCVA improvement of ≥ 15 letters from preoperative baseline to Day 90 [ Time Frame: Baseline, Day 90 ]
    As measured with Early Treatment of Diabetic Retinopathy Study (ETDRS) visual acuity charts
  • Proportion of subjects with BCVA improvement of ≥ 15 letters from preoperative baseline to Day 60 [ Time Frame: Baseline, Day 60 ]
    As measured with Early Treatment of Diabetic Retinopathy Study (ETDRS) visual acuity charts
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Nepafenac Once Daily for Macular Edema - Study 1
Official Title  ICMJE Randomized, Double-Masked, Vehicle Controlled, Clinical Evaluation To Assess The Safety And Efficacy Of Nepafenac Ophthalmic Suspension, 0.3% For Improvement In Clinical Outcomes Among Diabetic Subjects Following Cataract Surgery
Brief Summary The purpose of this study is to demonstrate superiority of Nepafenac Ophthalmic Suspension, 0.3% dosed once daily relative to Nepafenac Vehicle based upon clinical outcomes among diabetic subjects following cataract surgery.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Condition  ICMJE
  • Non-Proliferative Diabetic Retinopathy
  • Cataract
Intervention  ICMJE
  • Drug: Nepafenac Ophthalmic Suspension, 0.3%
    Test intervention
    Other Name: Nepafenac
  • Other: Nepafenac vehicle
    Inactive ingredients used as placebo comparator
  • Drug: Prednisolone acetate
    1 drop instilled in the operative eye 4 times daily beginning post-operatively on the day of surgery for the first 2 weeks, followed by 2 times daily for the next 2 weeks
    Other Names:
    • Omnipred™
    • Prednisolone acetate ophthalmic suspension
Study Arms  ICMJE
  • Experimental: Nepafenac
    With prednisolone acetate standard of care, Nepafenac Ophthalmic Suspension, 0.3%, 1 drop instilled in the operative eye 1 day prior to surgery, continuing on the day of surgery, and for 90 days following surgery. An additional 1 drop will be administered 30 to 120 minutes prior to surgery.
    Interventions:
    • Drug: Nepafenac Ophthalmic Suspension, 0.3%
    • Drug: Prednisolone acetate
  • Placebo Comparator: Vehicle
    With prednisolone acetate standard of care, Nepafenac vehicle, 1 drop instilled in the operative eye 1 day prior to surgery, continuing on the day of surgery, and for 90 days following surgery. An additional 1 drop will be administered 30 to 120 minutes prior to surgery.
    Interventions:
    • Other: Nepafenac vehicle
    • Drug: Prednisolone acetate
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: May 27, 2015)
881
Original Estimated Enrollment  ICMJE
 (submitted: May 10, 2013)
590
Actual Study Completion Date  ICMJE May 2015
Actual Primary Completion Date May 2015   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Planned cataract extraction by phacoemulsification with implantation of a posterior chamber intraocular lens;
  • History of Type 1 or 2 diabetes and non-proliferative diabetic retinopathy (NPDR) (mild, moderate, or severe) in the study eye;
  • Best corrected visual acuity (BCVA) of 73 letters or worse in the study eye with expectation of improvement after surgery;
  • Understand and sign an informed consent document;
  • Other protocol-defined inclusion criteria may apply.

Exclusion Criteria:

  • Pre-existing macular edema in the study eye;
  • History in the study eye of retinal detachment, wet age-related macular degeneration, chronic or recurrent inflammatory eye disease, or prior procedures;
  • Planned cataract surgery in the fellow eye after randomization and prior to the Day 90 postoperative study visit or through study exit;
  • Planned multiple procedures for the study eye during the cataract/intraocular lens implantation surgery;
  • Use of exclusionary medications, including nonsteroidal anti-inflammatory drugs (NSAIDs) and steroids, as specified in protocol.
  • Participation in any other clinical study within 30 days of the screening visit;
  • Females of childbearing potential who are breast feeding, have a positive urine pregnancy test at screening, are not willing to undergo a urine pregnancy test upon entering or exiting the study, intend to become pregnant during the study, or do not agree to use adequate birth control methods for the duration of the study;
  • Other protocol-defined exclusion criteria may apply.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Not Provided
Removed Location Countries United States
 
Administrative Information
NCT Number  ICMJE NCT01853072
Other Study ID Numbers  ICMJE C-12-067
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Alcon Research
Study Sponsor  ICMJE Alcon Research
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Clinical Project Lead GCRA, Pharma Alcon Research
PRS Account Alcon Research
Verification Date June 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP