- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01872611
Nepafenac Once Daily for Macular Edema - Study 2
June 22, 2016 updated by: Alcon Research
Randomized, Double-Masked, Vehicle Controlled, Clinical Evaluation To Assess The Safety And Efficacy Of Nepafenac Ophthalmic Suspension, 0.3% For Improvement In Clinical Outcomes Among Diabetic Subjects Following Cataract Surgery
The purpose of this study is to demonstrate superiority of Nepafenac Ophthalmic Suspension, 0.3% dosed once daily relative to Nepafenac Vehicle based upon clinical outcomes among diabetic participants following cataract surgery.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
819
Phase
- Phase 3
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Planned cataract extraction by phacoemulsification with implantation of a posterior chamber intraocular lens;
- History of Type 1 or 2 diabetes and non-proliferative diabetic retinopathy (NPDR) (mild, moderate, or severe) in the study eye;
- Best-corrected visual acuity (BCVA) of 73 letters or worse in the study eye with expectation of improvement after surgery;
- Understand and sign an informed consent document;
- Other protocol-defined inclusion criteria may apply.
Exclusion Criteria:
- Pre-existing macular edema in the study eye;
- History in the study eye of retinal detachment, wet age-related macular degeneration, chronic or recurrent inflammatory eye disease, or prior procedures;
- Planned cataract surgery in the fellow eye prior to the Day 90 postoperative study visit or through study exit;
- Planned multiple procedures for the study eye during the cataract/intraocular lens;
- Use of exclusionary medications, including nonsteroidal anti-inflammatory drugs (NSAIDs) and steroids, as specified in protocol.
- Participation in any other clinical study within 30 days of the screening visit;
- Females of childbearing potential who are breast feeding, have a positive urine pregnancy test at screening, are not willing to undergo a urine pregnancy test upon entering or exiting the study, intend to become pregnant during the study, or do not agree to use adequate birth control methods for the duration of the study;
- Other protocol-defined exclusion criteria may apply.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Nepafenac
With prednisolone acetate standard of care, Nepafenac Ophthalmic Suspension, 0.3%, 1 drop instilled in the operative eye 1 day prior to surgery, continuing on the day of surgery, and for 90 days following surgery.
An additional 1 drop will be administered 30 to 120 minutes prior to surgery.
|
1 drop instilled in the operative eye 4 times daily beginning post-operatively on the day of surgery for the first 2 weeks, followed by 2 times daily for the next 2 weeks
Other Names:
Other Names:
|
Placebo Comparator: Vehicle
With prednisolone acetate standard of care, Nepafenac vehicle, 1 drop instilled in the operative eye 1 day prior to surgery, continuing on the day of surgery, and for 90 days following surgery.
An additional 1 drop will be administered 30 to 120 minutes prior to surgery.
|
1 drop instilled in the operative eye 4 times daily beginning post-operatively on the day of surgery for the first 2 weeks, followed by 2 times daily for the next 2 weeks
Other Names:
Inactive ingredients used as placebo comparator
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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
|
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.
|
Baseline to Day 14, and maintained through Day 90
|
Percentage of Participants Who Develop Macular Edema Within 90 Days Following Cataract Surgery (Day 0)
Time Frame: Day 0 to Day 90
|
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.
|
Day 0 to Day 90
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Percentage of Participants With BCVA Improvement of ≥ 15 Letters From Preoperative Baseline to Day 90
Time Frame: Baseline to Day 90
|
Baseline to Day 90
|
Percentage of Participants With BCVA Improvement of ≥ 15 Letters From Preoperative Baseline to Day 60
Time Frame: Baseline to Day 60
|
Baseline to Day 60
|
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
|
Day 7 up to any visit through Day 90
|
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
|
Day 7 up to any visit through Day 90
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
June 1, 2013
Primary Completion (Actual)
May 1, 2015
Study Completion (Actual)
May 1, 2015
Study Registration Dates
First Submitted
June 5, 2013
First Submitted That Met QC Criteria
June 5, 2013
First Posted (Estimate)
June 7, 2013
Study Record Updates
Last Update Posted (Estimate)
August 2, 2016
Last Update Submitted That Met QC Criteria
June 22, 2016
Last Verified
June 1, 2016
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Cardiovascular Diseases
- Vascular Diseases
- Eye Diseases
- Endocrine System Diseases
- Diabetic Angiopathies
- Diabetes Complications
- Diabetes Mellitus
- Lens Diseases
- Retinal Diseases
- Diabetic Retinopathy
- Cataract
- Physiological Effects of Drugs
- Autonomic Agents
- Peripheral Nervous System Agents
- Analgesics
- Sensory System Agents
- Anti-Inflammatory Agents, Non-Steroidal
- Analgesics, Non-Narcotic
- Anti-Inflammatory Agents
- Antirheumatic Agents
- Antineoplastic Agents
- Antiemetics
- Gastrointestinal Agents
- Glucocorticoids
- Hormones
- Hormones, Hormone Substitutes, and Hormone Antagonists
- Antineoplastic Agents, Hormonal
- Neuroprotective Agents
- Protective Agents
- Prednisolone
- Methylprednisolone Acetate
- Methylprednisolone
- Methylprednisolone Hemisuccinate
- Prednisolone acetate
- Prednisolone hemisuccinate
- Prednisolone phosphate
- Nepafenac
Other Study ID Numbers
- C-12-071
- 2013-001874-12 (EudraCT Number)
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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