- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01318499
Nepafenac 0.3% Two Study
December 14, 2012 updated by: Alcon Research
Clinical Evaluation of Nepafenac Ophthalmic Suspension, 0.3% Compared to Nepafenac Ophthalmic Suspension 0.1% and Vehicle for Prevention and Treatment of Ocular Inflammation and Pain Associated With Cataract Surgery
The purpose of this study was to assess the safety and efficacy of Nepafenac Ophthalmic Suspension, 0.3% for the prevention and treatment of inflammation (swelling and redness) and pain in the eye after cataract extraction.
Study Overview
Status
Completed
Conditions
Study Type
Interventional
Enrollment (Actual)
1342
Phase
- Phase 2
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Texas
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Fort Worth, Texas, United States, 76134
- Contact Alcon Call Center for Trial Locations
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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
16 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Planned cataract extraction by phacoemulsification with the implantation of a posterior chamber intraocular lens;
- Patients who, in the opinion of the Investigator, would have improvement in best-corrected visual acuity after surgery;
- Able to understand and sign an informed consent;
- Other protocol-defined inclusion criteria may apply.
Exclusion Criteria:
- Use of topical ocular, inhaled or systemic nonsteroidal anti-inflammatory drugs within 7 days of surgery, with the exception of the allowed low dose of aspirin (up to 100 mg) prior to surgery and through study exit;
- Use of topical ocular, inhaled or systemic steroids within 14 days prior to surgery and through study exit;
- History of chronic or recurrent inflammatory eye disease (eg, iritis, scleritis, uveitis, iridocyclitis, rubeosis iridis) in the operative eye;
- Diabetic retinopathy in the operative eye;
- Known or suspected allergy or hypersensitivity to non-steroidal anti-inflammatory drugs (NSAIDs), or to any component of the test article;
- 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: Triple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Nepafenac 0.3%
Nepafenac Ophthalmic Suspension, 0.3%, one drop in affected eye once daily, for 16 days, beginning one day prior to surgery, continuing on the day of surgery, and for 14 days following surgery.
An additional drop was administered between 30-120 minutes prior to surgery.
|
Nepafenac Ophthalmic Suspension, 0.3%, one drop in affected eye once daily, for 16 days.
An additional drop was administered between 30-120 minutes prior to surgery.
|
Active Comparator: Nepafenac 0.1%
Nepafenac Ophthalmic Suspension, 0.1%, one drop in affected eye once daily, for 16 days, beginning one day prior to surgery, continuing on the day of surgery, and for 14 days following surgery.
An additional drop was administered between 30-120 minutes prior to surgery.
|
Nepafenac Ophthalmic Suspension, 0.1%, one drop in affected eye once daily, for 16 days.
An additional drop was administered between 30-120 minutes prior to surgery.
Other Names:
|
Placebo Comparator: Nepafenac Vehicle 0.3%
Nepafenac Vehicle 0.3%, one drop in affected eye once daily, for 16 days, beginning one day prior to surgery, continuing on the day of surgery, and for 14 days following surgery.
An additional drop was administered between 30-120 minutes prior to surgery.
|
Nepafenac Vehicle 0.3%, one drop in affected eye once daily, for 16 days.
An additional drop was administered between 30-120 minutes prior to surgery.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Percentage of Patients Cured at Day 14, Nepafenac 0.3% vs. Nepafenac Vehicle 0.3%
Time Frame: Day 14 postoperative
|
Ocular inflammation was assessed by the investigator during slit lamp examination.
Aqueous cells were scored on a 5-unit scale from 0 (none) to 4 (> 30 cells), and aqueous flare (protein escaping from dilated vessels) was scored on a 4-unit scale from 0 (no visible flare when compared with the normal eye) to 3 (severe - very dense flare).
To be considered cured, the patient must have had a score of 0 for both aqueous cells and aqueous flare.
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Day 14 postoperative
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Percentage of Patients Cured at Day 7, Nepafenac 0.3% vs. Nepafenac 0.1%
Time Frame: Day 7 postoperative
|
Ocular inflammation was assessed by the investigator during slit lamp examination.
Aqueous cells were scored on a 5-unit scale from 0 (none) to 4 (> 30 cells), and aqueous flare (protein escaping from dilated vessels) was scored on a 4-unit scale from 0 (no visible flare when compared with the normal eye) to 3 (severe - very dense flare).
To be considered cured, the patient must have had a score of 0 for both aqueous cells and aqueous flare.
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Day 7 postoperative
|
Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Cumulative Percentage of Patients Cured by Visit
Time Frame: Day 1, Day 3, Day 7, Day 14
|
Ocular inflammation was assessed by the investigator during slit lamp examination.
Aqueous cells were scored on a 5-unit scale from 0 (none) to 4 (> 30 cells), and aqueous flare (protein escaping from dilated vessels) was scored on a 4-unit scale from 0 (no visible flare when compared with the normal eye) to 3 (severe - very dense flare).
To be considered cured, the patient must have had a score of 0 for both aqueous cells and aqueous flare.
To be included in the cumulative summary at a visit, a patient must have been declared cured at the visit and remained cured at all subsequent visits.
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Day 1, Day 3, Day 7, Day 14
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Cumulative Percentage of Patients Pain Free by Visit
Time Frame: Day 1, Day 3, Day 7, Day 14
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Ocular pain was assessed by the patient on a 6-unit scale from 0 (none; absence of positive sensation), to 5 (severe; intense ocular, periocular or radiating pain requiring prescription analgesic).
Pain free was defined as an ocular pain assessment score of 0. To be included in the cumulative summary at a visit, a patient must have been declared pain free at the visit and remained pain free at all subsequent visits.
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Day 1, Day 3, Day 7, Day 14
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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
March 1, 2011
Primary Completion (Actual)
September 1, 2011
Study Completion (Actual)
September 1, 2011
Study Registration Dates
First Submitted
March 15, 2011
First Submitted That Met QC Criteria
March 17, 2011
First Posted (Estimate)
March 18, 2011
Study Record Updates
Last Update Posted (Estimate)
December 17, 2012
Last Update Submitted That Met QC Criteria
December 14, 2012
Last Verified
December 1, 2012
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- C-11-003
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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