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Nepafenac Once Daily for Macular Edema - Study 1

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Alcon Research
ClinicalTrials.gov Identifier:
NCT01853072
First received: May 10, 2013
Last updated: June 23, 2016
Last verified: June 2016
Results First Received: May 13, 2016  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Safety/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: Nepafenac 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 66 investigational centers located in the U.S., Latin America, and the Caribbean.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
Of the 881 participants enrolled, 253 were exited as screen failures and 13 were discontinued prior to randomization. This reporting group includes all randomized participants (615).

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

Participant Flow:   Overall Study
    Nepafenac   Vehicle
STARTED   308   307 
Randomized   308   307 
Treated (Safety Analysis Set)   301   302 
Full Analysis Set   298   300 
COMPLETED   296   286 
NOT COMPLETED   12   21 
Adverse event prior to treatment                0                1 
Adverse Event                0                3 
Death                1                4 
Lost to Follow-up                0                3 
Non-compliance with study drug                0                1 
Physician Decision                1                1 
Withdrawal by Subject                1                2 
Reason not specified                9                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 including 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 
Overall Participants Analyzed 
[Units: Participants]
 298   300   598 
Age 
[Units: Years]
Mean (Standard Deviation)
 66.8  (8.5)   66.8  (8.3)   66.8  (8.4) 
Gender 
[Units: Participants]
     
Female   158   166   324 
Male   140   134   274 


  Outcome Measures
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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]   [ 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: NCT01853072     History of Changes
Other Study ID Numbers: C-12-067
Study First Received: May 10, 2013
Results First Received: May 13, 2016
Last Updated: June 23, 2016
Health Authority: United States: Food and Drug Administration
United States: Institutional Review Board
Colombia: Ethics Committee
Dominican Republic: Consejo Nacional de Bioetica en Salud
Mexico: Institutional Review Board
Panama: Commemorative Institute GORGAS of Studies of Health