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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

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Double (Participant, Investigator);   Primary Purpose: Treatment
Conditions Non-Proliferative Diabetic Retinopathy
Cataract
Interventions Drug: Nepafenac Ophthalmic Suspension, 0.3%
Other: Nepafenac vehicle
Drug: Prednisolone acetate
Enrollment 881
Recruitment Details Participants were recruited from 66 investigational centers located in the U.S., Latin America, and the Caribbean.
Pre-assignment Details 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).
Arm/Group Title Nepafenac Vehicle
Hide Arm/Group Description Nepafenac Ophthalmic Suspension, 0.3% Nepafenac Ophthalmic Suspension Vehicle
Period Title: Overall Study
Started 308 307
Randomized 308 307
Treated (Safety Analysis Set) 301 302
Full Analysis Set 298 300
Completed 296 286
Not Completed 12 21
Reason Not Completed
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
Arm/Group Title Nepafenac Vehicle Total
Hide Arm/Group Description Nepafenac Ophthalmic Suspension, 0.3% Nepafenac Ophthalmic Suspension Vehicle Total of all reporting groups
Overall Number of Baseline Participants 298 300 598
Hide Baseline Analysis Population Description
Full analysis set, defined as including all randomized participants who completed implant surgery and had at least one on-therapy postsurgical visit.
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 298 participants 300 participants 598 participants
66.8  (8.5) 66.8  (8.3) 66.8  (8.4)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 298 participants 300 participants 598 participants
Female
158
  53.0%
166
  55.3%
324
  54.2%
Male
140
  47.0%
134
  44.7%
274
  45.8%
1.Primary Outcome
Title Percentage of Participants With Best-corrected Visual Acuity (BCVA) Improvement of ≥ 15 Letters From Preoperative Baseline to Day 14 and Maintained Through Day 90
Hide Description 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.
Time Frame Baseline to Day 14, and maintained through Day 90
Hide Outcome Measure Data
Hide Analysis Population Description
Full analysis set
Arm/Group Title Nepafenac Vehicle
Hide Arm/Group Description:
Nepafenac Ophthalmic Suspension, 0.3%
Nepafenac Ophthalmic Suspension Vehicle
Overall Number of Participants Analyzed 298 300
Measure Type: Number
Unit of Measure: Percentage of participants
61.7 43.0
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Nepafenac, Vehicle
Comments This endpoint was considered primary for United States (US) registration and secondary for European Union (EU) registration.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments [Not Specified]
Method Regression, Logistic
Comments [Not Specified]
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 2.1
Confidence Interval (2-Sided) 95%
1.5 to 3.0
Parameter Dispersion
Type: Standard Error of the mean
Value: 0.4
Estimation Comments Parameter dispersion is the standard error for the odds ratio.
2.Primary Outcome
Title Percentage of Participants Who Develop Macular Edema Within 90 Days Following Cataract Surgery (Day 0)
Hide Description 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.
Time Frame Day 0 to Day 90
Hide Outcome Measure Data
Hide Analysis Population Description
Full analysis set
Arm/Group Title Nepafenac Vehicle
Hide Arm/Group Description:
Nepafenac Ophthalmic Suspension, 0.3%
Nepafenac Ophthalmic Suspension Vehicle
Overall Number of Participants Analyzed 298 300
Measure Type: Number
Unit of Measure: Percentage of participants
2.3 17.3
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Nepafenac, Vehicle
Comments This endpoint was considered primary for EU registration and secondary for US registration.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments [Not Specified]
Method Regression, Logistic
Comments [Not Specified]
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 0.1
Confidence Interval (2-Sided) 95%
0.1 to 0.3
Parameter Dispersion
Type: Standard Error of the mean
Value: 0.1
Estimation Comments Parameter dispersion is the standard error for the odds ratio.
3.Secondary Outcome
Title Percentage of Participants With BCVA Improvement of ≥ 15 Letters From Preoperative Baseline to Day 90
Hide Description [Not Specified]
Time Frame Baseline to Day 90
Hide Outcome Measure Data
Hide Analysis Population Description
Full analysis set
Arm/Group Title Nepafenac Vehicle
Hide Arm/Group Description:
Nepafenac Ophthalmic Suspension, 0.3%
Nepafenac Ophthalmic Suspension Vehicle
Overall Number of Participants Analyzed 298 300
Measure Type: Number
Unit of Measure: Percentage of participants
77.2 67.7
4.Secondary Outcome
Title Percentage of Participants With BCVA Improvement of ≥ 15 Letters From Preoperative Baseline to Day 60
Hide Description [Not Specified]
Time Frame Baseline to Day 60
Hide Outcome Measure Data
Hide Analysis Population Description
Full analysis set
Arm/Group Title Nepafenac Vehicle
Hide Arm/Group Description:
Nepafenac Ophthalmic Suspension, 0.3%
Nepafenac Ophthalmic Suspension Vehicle
Overall Number of Participants Analyzed 298 300
Measure Type: Number
Unit of Measure: Percentage of participants
76.2 64.7
5.Secondary Outcome
Title Percentage of Participants With a > 5-letter Loss in BCVA From Day 7 to Any Visit [Time Frame: Day 7 up to Any Visit]
Hide Description [Not Specified]
Time Frame Day 7 up to any visit through Day 90
Hide Outcome Measure Data
Hide Analysis Population Description
Full analysis set
Arm/Group Title Nepafenac Vehicle
Hide Arm/Group Description:
Nepafenac Ophthalmic Suspension, 0.3%
Nepafenac Ophthalmic Suspension Vehicle
Overall Number of Participants Analyzed 298 300
Measure Type: Number
Unit of Measure: percentage of participants
15.4 27.3
6.Secondary Outcome
Title Percentage of Participants With With a > 10-letter Loss in BCVA From Day 7 to Any Visit
Hide Description [Not Specified]
Time Frame Day 7 up to any visit through Day 90
Hide Outcome Measure Data
Hide Analysis Population Description
Full analysis set
Arm/Group Title Nepafenac Vehicle
Hide Arm/Group Description:
Nepafenac Ophthalmic Suspension, 0.3%
Nepafenac Ophthalmic Suspension Vehicle
Overall Number of Participants Analyzed 298 300
Measure Type: Number
Unit of Measure: percentage of participants
9.1 15.3
Time Frame Reporting of adverse events (AEs) began once informed consent was obtained from the subject and continued through Day 90 (or Day 120, if unresolved macular edema present at Day 90). Ocular AEs are presented for both study eye and non-study eye combined.
Adverse Event Reporting Description An AE was defined as any untoward medical occurrence in a subject after signing the informed consent document. AEs were reported as pretreatment, treatment-emergent, and posttreatment. Reports of AEs were obtained through solicited and spontaneous comments from the participants.
 
Arm/Group Title Pretreatment Nepafenac Vehicle Posttreatment
Hide Arm/Group Description All participants who consented to participate in the study prior to the initiation of study treatment All participants treated with Nepafenac during the course of study treatment All participants treated with NepafenacVehicle during the course of study treatment All participants after cessation of study treatment up to study exit
All-Cause Mortality
Pretreatment Nepafenac Vehicle Posttreatment
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/--   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Pretreatment Nepafenac Vehicle Posttreatment
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   14/881 (1.59%)   13/301 (4.32%)   14/302 (4.64%)   9/603 (1.49%) 
Blood and lymphatic system disorders         
Anaemia  1  0/881 (0.00%)  1/301 (0.33%)  0/302 (0.00%)  0/603 (0.00%) 
Cardiac disorders         
Acute coronary syndrome  1  0/881 (0.00%)  0/301 (0.00%)  1/302 (0.33%)  0/603 (0.00%) 
Angina pectoris  1  1/881 (0.11%)  0/301 (0.00%)  0/302 (0.00%)  0/603 (0.00%) 
Atrial fibrillation  1  1/881 (0.11%)  0/301 (0.00%)  0/302 (0.00%)  1/603 (0.17%) 
Bradycardia  1  2/881 (0.23%)  0/301 (0.00%)  0/302 (0.00%)  0/603 (0.00%) 
Cardiac arrest  1  0/881 (0.00%)  0/301 (0.00%)  0/302 (0.00%)  1/603 (0.17%) 
Cardiac failure congestive  1  0/881 (0.00%)  0/301 (0.00%)  3/302 (0.99%)  1/603 (0.17%) 
Myocardial infarction  1  1/881 (0.11%)  1/301 (0.33%)  1/302 (0.33%)  1/603 (0.17%) 
Cardiac Failure  1  0/881 (0.00%)  0/301 (0.00%)  0/302 (0.00%)  1/603 (0.17%) 
Eye disorders         
Diabetic retinopathy  1  0/881 (0.00%)  0/301 (0.00%)  0/302 (0.00%)  1/603 (0.17%) 
Retinal detachment  1  0/881 (0.00%)  0/301 (0.00%)  0/302 (0.00%)  1/603 (0.17%) 
Gastrointestinal disorders         
Rectal haemorrhage  1  1/881 (0.11%)  0/301 (0.00%)  0/302 (0.00%)  0/603 (0.00%) 
General disorders         
Non-cardiac chest pain  1  0/881 (0.00%)  0/301 (0.00%)  1/302 (0.33%)  0/603 (0.00%) 
Oedema peripheral  1  0/881 (0.00%)  0/301 (0.00%)  1/302 (0.33%)  0/603 (0.00%) 
Hepatobiliary disorders         
Acute hepatic failure  1  0/881 (0.00%)  1/301 (0.33%)  0/302 (0.00%)  0/603 (0.00%) 
Hepatic failure  1  0/881 (0.00%)  0/301 (0.00%)  0/302 (0.00%)  1/603 (0.17%) 
Infections and infestations         
Bronchitis  1  0/881 (0.00%)  1/301 (0.33%)  0/302 (0.00%)  0/603 (0.00%) 
Candidiasis  1  1/881 (0.11%)  0/301 (0.00%)  0/302 (0.00%)  0/603 (0.00%) 
Cellulitis  1  2/881 (0.23%)  0/301 (0.00%)  0/302 (0.00%)  1/603 (0.17%) 
Diverticulitis  1  0/881 (0.00%)  1/301 (0.33%)  0/302 (0.00%)  0/603 (0.00%) 
Pericolic abscess  1  0/881 (0.00%)  1/301 (0.33%)  0/302 (0.00%)  0/603 (0.00%) 
Peritonitis  1  0/881 (0.00%)  1/301 (0.33%)  0/302 (0.00%)  0/603 (0.00%) 
Pneumonia  1  0/881 (0.00%)  0/301 (0.00%)  1/302 (0.33%)  2/603 (0.33%) 
Retroperitoneal abscess  1  0/881 (0.00%)  0/301 (0.00%)  1/302 (0.33%)  0/603 (0.00%) 
Sepsis  1  0/881 (0.00%)  0/301 (0.00%)  3/302 (0.99%)  0/603 (0.00%) 
Urinary tract infection  1  1/881 (0.11%)  0/301 (0.00%)  1/302 (0.33%)  0/603 (0.00%) 
Viral infection  1  0/881 (0.00%)  1/301 (0.33%)  0/302 (0.00%)  0/603 (0.00%) 
Wound infection  1  0/881 (0.00%)  0/301 (0.00%)  1/302 (0.33%)  0/603 (0.00%) 
Osteomyelitis  1  0/881 (0.00%)  0/301 (0.00%)  0/302 (0.00%)  1/603 (0.17%) 
Injury, poisoning and procedural complications         
Alcohol poisoning  1  0/881 (0.00%)  1/301 (0.33%)  0/302 (0.00%)  0/603 (0.00%) 
Eye injury  1  0/881 (0.00%)  1/301 (0.33%)  0/302 (0.00%)  0/603 (0.00%) 
Laceration  1  1/881 (0.11%)  0/301 (0.00%)  0/302 (0.00%)  0/603 (0.00%) 
Multiple fractures  1  1/881 (0.11%)  0/301 (0.00%)  0/302 (0.00%)  0/603 (0.00%) 
Investigations         
Arteriogram  1  0/881 (0.00%)  1/301 (0.33%)  0/302 (0.00%)  0/603 (0.00%) 
Metabolism and nutrition disorders         
Dehydration  1  1/881 (0.11%)  0/301 (0.00%)  0/302 (0.00%)  0/603 (0.00%) 
Hypokalaemia  1  0/881 (0.00%)  0/301 (0.00%)  1/302 (0.33%)  0/603 (0.00%) 
Diabetes mellitus  1  0/881 (0.00%)  0/301 (0.00%)  0/302 (0.00%)  1/603 (0.17%) 
Neoplasms benign, malignant and unspecified (incl cysts and polyps)         
Small cell lung cancer  1  0/881 (0.00%)  1/301 (0.33%)  0/302 (0.00%)  0/603 (0.00%) 
Nervous system disorders         
Hepatic encephalopathy  1  0/881 (0.00%)  1/301 (0.33%)  0/302 (0.00%)  0/603 (0.00%) 
Transient ischaemic attack  1  0/881 (0.00%)  1/301 (0.33%)  1/302 (0.33%)  0/603 (0.00%) 
VIth nerve paralysis  1  0/881 (0.00%)  0/301 (0.00%)  1/302 (0.33%)  0/603 (0.00%) 
Psychiatric disorders         
Confusional state  1  0/881 (0.00%)  1/301 (0.33%)  0/302 (0.00%)  0/603 (0.00%) 
Renal and urinary disorders         
Acute prerenal failure  1  0/881 (0.00%)  1/301 (0.33%)  0/302 (0.00%)  0/603 (0.00%) 
Renal failure acute  1  0/881 (0.00%)  1/301 (0.33%)  0/302 (0.00%)  1/603 (0.17%) 
Renal failure chronic  1  0/881 (0.00%)  1/301 (0.33%)  0/302 (0.00%)  1/603 (0.17%) 
Respiratory, thoracic and mediastinal disorders         
Dyspnoea  1  1/881 (0.11%)  0/301 (0.00%)  0/302 (0.00%)  0/603 (0.00%) 
Acute respiratory failure  1  0/881 (0.00%)  0/301 (0.00%)  0/302 (0.00%)  1/603 (0.17%) 
Surgical and medical procedures         
Cholecystectomy  1  0/881 (0.00%)  1/301 (0.33%)  0/302 (0.00%)  0/603 (0.00%) 
Vascular disorders         
Deep vein thrombosis  1  1/881 (0.11%)  0/301 (0.00%)  0/302 (0.00%)  0/603 (0.00%) 
Hypertension  1  0/881 (0.00%)  1/301 (0.33%)  0/302 (0.00%)  0/603 (0.00%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA (16.0)
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Pretreatment Nepafenac Vehicle Posttreatment
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   0/881 (0.00%)   0/301 (0.00%)   0/302 (0.00%)   0/603 (0.00%) 
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.
Sponsor reserves the right of prior review of any publication or presentation of information related to the study.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Therapeutic Unit Head, Cornea and Inflammation
Organization: Alcon Research, Ltd.
Phone: 1-888-451-3937
EMail: alcon.medinfo@alcon.com
Layout table for additonal information
Responsible Party: Alcon Research
ClinicalTrials.gov Identifier: NCT01853072     History of Changes
Other Study ID Numbers: C-12-067
First Submitted: May 10, 2013
First Posted: May 14, 2013
Results First Submitted: May 13, 2016
Results First Posted: August 3, 2016
Last Update Posted: August 3, 2016