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Trial record 24 of 25 for:    "Lens Disease" | "Nepafenac"

Nepafenac Once Daily for Macular Edema - Study 2

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ClinicalTrials.gov Identifier: NCT01872611
Recruitment Status : Completed
First Posted : June 7, 2013
Results First Posted : August 2, 2016
Last Update Posted : August 2, 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: Vehicle
Drug: Prednisolone acetate
Enrollment 819
Recruitment Details 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 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).
Arm/Group Title Nepafenac Vehicle
Hide Arm/Group Description Nepafenac Ophthalmic Suspension, 0.3% Nepafenac Ophthalmic Suspension Vehicle
Period Title: Overall Study
Started 301 304
Randomized 301 304
Treated (Safety Analysis Set) 293 295
Full Analysis Set 289 293
Completed 277 292
Not Completed 24 12
Reason Not Completed
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
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 289 293 582
Hide Baseline Analysis Population Description
Full analysis set, defined as 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 289 participants 293 participants 582 participants
67.7  (8.5) 68.1  (8.4) 67.9  (8.4)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 289 participants 293 participants 582 participants
Female
149
  51.6%
149
  50.9%
298
  51.2%
Male
140
  48.4%
144
  49.1%
284
  48.8%
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 289 293
Measure Type: Number
Unit of Measure: Percentage of participants
48.8 50.5
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 0.671
Comments [Not Specified]
Method Regression, Logistic
Comments [Not Specified]
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 0.9
Confidence Interval (2-Sided) 95%
0.7 to 1.3
Parameter Dispersion
Type: Standard Error of the mean
Value: 0.2
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 289 293
Measure Type: Number
Unit of Measure: Percentage of participants
5.9 14.3
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 0.4
Confidence Interval (2-Sided) 95%
0.2 to 0.7
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 289 293
Measure Type: Number
Unit of Measure: Percentage of participants
65.4 65.9
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 289 293
Measure Type: Number
Unit of Measure: Percentage of participants
68.9 62.1
5.Secondary Outcome
Title Percentage of Participants With a > 5-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 289 293
Measure Type: Number
Unit of Measure: percentage of participants
18.7 16.7
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 289 293
Measure Type: Number
Unit of Measure: percentage of participants
10.7 8.9
Time Frame Reporting of adverse events (AEs) began once informed consent was obtained and continued through Day 90 (or Day 120, if unresolved macular edema present at Day 90). Ocular adverse events are presented for both study eye and nonstudy eye combined.
Adverse Event Reporting Description An AE was defined as any untoward medical occurrence in a participant after signing the informed consent and did not necessarily have to have a causal relationship with the study treatment. AEs were reported as pretreatment, treatment-emergent, and posttreatment. 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 Nepafenac Ophthalmic Suspension, 0.3% Nepafenac Ophthalmic Suspension Vehicle 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   5/819 (0.61%)   14/293 (4.78%)   14/295 (4.75%)   4/588 (0.68%) 
Blood and lymphatic system disorders         
Anaemia  1  1/819 (0.12%)  0/293 (0.00%)  0/295 (0.00%)  1/588 (0.17%) 
Cardiac disorders         
Angina pectoris  1  0/819 (0.00%)  0/293 (0.00%)  1/295 (0.34%)  0/588 (0.00%) 
Atrial fibrillation  1  0/819 (0.00%)  0/293 (0.00%)  1/295 (0.34%)  0/588 (0.00%) 
Atrial flutter  1  0/819 (0.00%)  0/293 (0.00%)  1/295 (0.34%)  0/588 (0.00%) 
Cardiac failure  1  0/819 (0.00%)  0/293 (0.00%)  1/295 (0.34%)  0/588 (0.00%) 
Cardiac failure congestive  1  0/819 (0.00%)  0/293 (0.00%)  1/295 (0.34%)  0/588 (0.00%) 
Coronary artery occlusion  1  0/819 (0.00%)  1/293 (0.34%)  0/295 (0.00%)  0/588 (0.00%) 
Eye disorders         
Diabetic retinal oedema  1  0/819 (0.00%)  0/293 (0.00%)  0/295 (0.00%)  1/588 (0.17%) 
Optic ischaemic neuropathy  1  0/819 (0.00%)  0/293 (0.00%)  0/295 (0.00%)  1/588 (0.17%) 
Posterior capsule rupture  1  0/819 (0.00%)  1/293 (0.34%)  0/295 (0.00%)  0/588 (0.00%) 
Gastrointestinal disorders         
Rectal haemorrhage  1  0/819 (0.00%)  0/293 (0.00%)  1/295 (0.34%)  0/588 (0.00%) 
General disorders         
Chest pain  1  0/819 (0.00%)  0/293 (0.00%)  1/295 (0.34%)  0/588 (0.00%) 
Device dislocation  1  0/819 (0.00%)  1/293 (0.34%)  0/295 (0.00%)  0/588 (0.00%) 
Immune system disorders         
Anaphylactic shock  1  0/819 (0.00%)  0/293 (0.00%)  1/295 (0.34%)  0/588 (0.00%) 
Infections and infestations         
Appendicitis  1  0/819 (0.00%)  1/293 (0.34%)  0/295 (0.00%)  0/588 (0.00%) 
Cellulitis  1  0/819 (0.00%)  1/293 (0.34%)  0/295 (0.00%)  0/588 (0.00%) 
Herpes zoster  1  0/819 (0.00%)  1/293 (0.34%)  0/295 (0.00%)  0/588 (0.00%) 
Pyelonephritis acute  1  0/819 (0.00%)  0/293 (0.00%)  1/295 (0.34%)  0/588 (0.00%) 
Urinary tract infection  1  0/819 (0.00%)  0/293 (0.00%)  2/295 (0.68%)  0/588 (0.00%) 
Injury, poisoning and procedural complications         
Femur fracture  1  0/819 (0.00%)  0/293 (0.00%)  1/295 (0.34%)  0/588 (0.00%) 
Lumbar vertebral fracture  1  0/819 (0.00%)  1/293 (0.34%)  0/295 (0.00%)  0/588 (0.00%) 
Metabolism and nutrition disorders         
Hypokalaemia  1  0/819 (0.00%)  0/293 (0.00%)  0/295 (0.00%)  1/588 (0.17%) 
Musculoskeletal and connective tissue disorders         
Back pain  1  0/819 (0.00%)  1/293 (0.34%)  0/295 (0.00%)  0/588 (0.00%) 
Intervertebral disc degeneration  1  0/819 (0.00%)  1/293 (0.34%)  0/295 (0.00%)  0/588 (0.00%) 
Vertebral foraminal stenosis  1  0/819 (0.00%)  1/293 (0.34%)  0/295 (0.00%)  0/588 (0.00%) 
Nervous system disorders         
Cerebrovascular accident  1  0/819 (0.00%)  2/293 (0.68%)  1/295 (0.34%)  0/588 (0.00%) 
Hepatic encephalopathy  1  0/819 (0.00%)  0/293 (0.00%)  1/295 (0.34%)  0/588 (0.00%) 
Respiratory, thoracic and mediastinal disorders         
Acute respiratory distress syndrome  1  1/819 (0.12%)  0/293 (0.00%)  0/295 (0.00%)  0/588 (0.00%) 
Acute respiratory failure  1  0/819 (0.00%)  1/293 (0.34%)  0/295 (0.00%)  0/588 (0.00%) 
Chronic obstructive pulmonary disease  1  0/819 (0.00%)  1/293 (0.34%)  0/295 (0.00%)  0/588 (0.00%) 
Surgical and medical procedures         
Arteriovenous fistula operation  1  0/819 (0.00%)  0/293 (0.00%)  1/295 (0.34%)  0/588 (0.00%) 
Cardiac operation  1  1/819 (0.12%)  0/293 (0.00%)  0/295 (0.00%)  0/588 (0.00%) 
Cataract operation  1  1/819 (0.12%)  0/293 (0.00%)  0/295 (0.00%)  0/588 (0.00%) 
Intra-ocular injection  1  0/819 (0.00%)  0/293 (0.00%)  1/295 (0.34%)  0/588 (0.00%) 
Skin graft  1  0/819 (0.00%)  1/293 (0.34%)  0/295 (0.00%)  0/588 (0.00%) 
Vascular disorders         
Hypertension  1  1/819 (0.12%)  0/293 (0.00%)  1/295 (0.34%)  0/588 (0.00%) 
Hypertensive crisis  1  0/819 (0.00%)  1/293 (0.34%)  0/295 (0.00%)  0/588 (0.00%) 
Peripheral artery stenosis  1  0/819 (0.00%)  1/293 (0.34%)  0/295 (0.00%)  0/588 (0.00%) 
Thrombosis  1  0/819 (0.00%)  1/293 (0.34%)  0/295 (0.00%)  0/588 (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   0/819 (0.00%)   0/293 (0.00%)   0/295 (0.00%)   0/588 (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: NCT01872611     History of Changes
Other Study ID Numbers: C-12-071
2013-001874-12 ( EudraCT Number )
First Submitted: June 5, 2013
First Posted: June 7, 2013
Results First Submitted: May 24, 2016
Results First Posted: August 2, 2016
Last Update Posted: August 2, 2016