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Trial record 62 of 10804 for:    Placebo AND once

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

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ClinicalTrials.gov Identifier: NCT03025945
Recruitment Status : Completed
First Posted : January 20, 2017
Results First Posted : December 14, 2018
Last Update Posted : December 14, 2018
Sponsor:
Information provided by (Responsible Party):
Intuor Technologies, Inc.

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Double (Participant, Investigator);   Primary Purpose: Treatment
Condition Cystoid Macular Edema
Interventions Drug: Nepafenac 0.3%
Drug: Saline Solution
Enrollment 662
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Nepafenac 0.3% Saline Solution
Hide Arm/Group Description

nepafenac 0.3% ophthalmic solution dosed once daily

Nepafenac 0.3%

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

Saline Solution

Period Title: Overall Study
Started 331 331
Completed 331 331
Not Completed 0 0
Arm/Group Title Nepafenac 0.3% Saline Solution Total
Hide Arm/Group Description

nepafenac 0.3% ophthalmic solution dosed once daily

Nepafenac 0.3%

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

Saline Solution

Total of all reporting groups
Overall Number of Baseline Participants 331 331 662
Overall Number of Units Analyzed
Type of Units Analyzed: Eyes
500 500 1000
Hide Baseline Analysis Population Description
Six hundred and sixty two (662) patients, one thousand eyes (1000), completed the study. 1:1 ratio of control: treatment. Subjects were chosen from patients who had visually significant cataracts and were to undergo phacoemulsification with implantation of an intracapsular positioned intraocular lens.
Age, Continuous  
Mean (Full Range)
Unit of measure:  Years
Number Analyzed 331 participants 331 participants 662 participants
68.8
(31 to 94)
67.9
(39 to 96)
68.3
(31 to 96)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 331 participants 331 participants 662 participants
Female
182
  55.0%
182
  55.0%
364
  55.0%
Male
149
  45.0%
149
  45.0%
298
  45.0%
Macular volume  
Mean (Standard Deviation)
Unit of measure:  Mm
Number Analyzed 331 participants 331 participants 662 participants
8.7  (0.15) 8.75  (0.15) 8.72  (0.15)
1.Primary Outcome
Title Post-operative Clinical Findings of Cystoid Macular Edema
Hide Description post-operative macular volume (mm)
Time Frame 6 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Nepafenac 0.3% Saline Solution
Hide Arm/Group Description:

nepafenac 0.3% ophthalmic solution dosed once daily

Nepafenac 0.3%

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

Saline Solution

Overall Number of Participants Analyzed 331 331
Overall Number of Units Analyzed
Type of Units Analyzed: Eyes
500 500
Mean (Standard Deviation)
Unit of Measure: mm
8.85  (0.13) 8.95  (0.18)
Time Frame 3 weeks
Adverse Event Reporting Description Any untoward or unfavorable medical occurrence in a participant, including any abnormal sign, symptom, or disease, temporally associated with the participant’s participation in the research, whether or not considered related to the participant’s participation in the research.
 
Arm/Group Title Nepafenac 0.3% Saline Solution
Hide Arm/Group Description

nepafenac 0.3% ophthalmic solution dosed once daily

Nepafenac 0.3%

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

Saline Solution

All-Cause Mortality
Nepafenac 0.3% Saline Solution
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--    
Show Serious Adverse Events Hide Serious Adverse Events
Nepafenac 0.3% Saline Solution
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   0/331 (0.00%)      0/331 (0.00%)    
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Nepafenac 0.3% Saline Solution
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   1/331 (0.30%)      0/331 (0.00%)    
Eye disorders     
drop intolerance   1/331 (0.30%)  1 0/331 (0.00%)  0
Indicates events were collected by systematic assessment
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT 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.
Results Point of Contact
Name/Title: Sean McCafferty, MD
Organization: Arizona Eye Consultants
Phone: 520-327-3487
Responsible Party: Intuor Technologies, Inc.
ClinicalTrials.gov Identifier: NCT03025945     History of Changes
Other Study ID Numbers: CME and nepafenac 0.3%
First Submitted: January 14, 2017
First Posted: January 20, 2017
Results First Submitted: October 2, 2018
Results First Posted: December 14, 2018
Last Update Posted: December 14, 2018