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Nepafenac Once Daily for Macular Edema - Study 2

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Alcon Research
ClinicalTrials.gov Identifier:
NCT01872611
First received: June 5, 2013
Last updated: June 22, 2016
Last verified: June 2016
Results First Received: May 24, 2016  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Double Blind (Subject, Investigator);   Primary Purpose: Treatment
Conditions: Non-Proliferative Diabetic Retinopathy
Cataract
Interventions: Drug: Nepafenac Ophthalmic Suspension, 0.3%
Other: Vehicle
Drug: Prednisolone acetate

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
Participants were recruited from 73 investigational centers located in the U.S., Europe, the Middle East, Africa, Latin America, the Caribbean, and the Asia Pacific region.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
Of the 819 participants enrolled, 191 were exited as screen failures and 23 were discontinued prior to randomization. This reporting group includes all randomized participants (605).

Reporting Groups
  Description
Nepafenac Nepafenac Ophthalmic Suspension, 0.3%
Vehicle Nepafenac Ophthalmic Suspension Vehicle

Participant Flow:   Overall Study
    Nepafenac     Vehicle  
STARTED     301     304  
Randomized     301     304  
Treated (Safety Analysis Set)     293     295  
Full Analysis Set     289     293  
COMPLETED     277     292  
NOT COMPLETED     24     12  
Adverse Event                 3                 1  
Adverse Event, prior to treatment                 0                 1  
Death                 0                 1  
Death, prior to treatment                 0                 1  
Lost to Follow-up                 8                 1  
Physician Decision                 1                 0  
Withdrawal by Subject                 6                 1  
Reason not provided                 6                 6  



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
Full analysis set, defined as all randomized participants who completed implant surgery and had at least one on-therapy postsurgical visit.

Reporting Groups
  Description
Nepafenac Nepafenac Ophthalmic Suspension, 0.3%
Vehicle Nepafenac Ophthalmic Suspension Vehicle
Total Total of all reporting groups

Baseline Measures
    Nepafenac     Vehicle     Total  
Number of Participants  
[units: participants]
  289     293     582  
Age  
[units: years]
Mean (Standard Deviation)
  67.7  (8.5)     68.1  (8.4)     67.9  (8.4)  
Gender  
[units: participants]
     
Female     149     149     298  
Male     140     144     284  



  Outcome Measures
  Show All Outcome Measures

1.  Primary:   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 ]

2.  Primary:   Percentage of Participants Who Develop Macular Edema Within 90 Days Following Cataract Surgery (Day 0)   [ Time Frame: Day 0 to Day 90 ]

3.  Secondary:   Percentage of Participants With BCVA Improvement of ≥ 15 Letters From Preoperative Baseline to Day 90   [ Time Frame: Baseline to Day 90 ]

4.  Secondary:   Percentage of Participants With BCVA Improvement of ≥ 15 Letters From Preoperative Baseline to Day 60   [ Time Frame: Baseline to Day 60 ]

5.  Secondary:   Percentage of Participants With a > 5-letter Loss in BCVA From Day 7 to Any Visit   [ Time Frame: Day 7 up to any visit through Day 90 ]

6.  Secondary:   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 ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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  More Information
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Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
The agreement is:
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.


Results Point of Contact:  
Name/Title: Therapeutic Unit Head, Cornea and Inflammation
Organization: Alcon Research, Ltd.
phone: 1-888-451-3937
e-mail: alcon.medinfo@alcon.com



Responsible Party: Alcon Research
ClinicalTrials.gov Identifier: NCT01872611     History of Changes
Other Study ID Numbers: C-12-071
2013-001874-12 ( EudraCT Number )
Study First Received: June 5, 2013
Results First Received: May 24, 2016
Last Updated: June 22, 2016
Health Authority: United States: Food and Drug Administration
United States: Institutional Review Board
Mexico: Ethics Committee
Germany: Ethics Commission
Austria: Ethikkommission
Australia: Human Research Ethics Committee
Hungary: Institutional Ethics Committee
Italy: Ethics Committee
Spain: Ethics Committee
France: Ethics Committee
Colombia: Ethics Committee
Philippines: Ethics Committee
Singapore: Institutional Review Board
Israel: Ethics Commission
Peru: Ethics Committee