Back to resultsConfirmatory Study Nepafenac 0.3%
Primary Purpose
Cataract
Status
Completed
Phase
Phase 3
Locations
United States
Study Type
Interventional
Intervention
Nepafenac Ophthalmic Suspension, 0.3%
Nepafenac Ophthalmic Suspension, 0.1%
Nepafenac Ophthalmic Suspension 0.3% Vehicle
NEVANAC Vehicle
Sponsored by
About this trial
This is an interventional treatment trial for Cataract
Eligibility Criteria
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.
Sites / Locations
- Contact Alcon Call Center For Trial Locations
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm Type
Experimental
Active Comparator
Placebo Comparator
Placebo Comparator
Arm Label
Nepafenac 0.3%
NEVANAC
Nepafenac Vehicle 0.3%
NEVANAC Vehicle
Arm Description
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 dose was administered between 30-120 minutes prior to surgery.
Nepafenac Ophthalmic Suspension, 0.1%, one drop in affected eye three times daily, beginning one day prior to surgery, continuing on the day of surgery, and for 14 days following surgery.
Nepafenac Ophthalmic Suspension 0.3% Vehicle, 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 dose was administered between 30-120 minutes prior to surgery.
Nepafenac 0.1% vehicle, one drop in affected eye three times daily, beginning one day prior to surgery, continuing on the day of surgery, and for 14 days following surgery.
Outcomes
Primary Outcome Measures
Percentage of Patients Cured at 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 cells and flare.
Secondary Outcome Measures
Percentage of Patients Pain-Free at Day 14
Ocular pain as assessed by the investigator on a scale ranging from 0 (none) to 5 (severe). Pain-free was defined as a score of 0 on the investigator's assessment of ocular pain.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01109173
Brief Title
Confirmatory Study Nepafenac 0.3%
Official Title
Clinical Evaluation of Nepafenac Ophthalmic Suspension, 0.3% for Prevention and Treatment of Ocular Inflammation and Pain After Cataract Surgery
Study Type
Interventional
2. Study Status
Record Verification Date
November 2012
Overall Recruitment Status
Completed
Study Start Date
June 2010 (undefined)
Primary Completion Date
May 2011 (Actual)
Study Completion Date
undefined (undefined)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Alcon Research
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
The purpose of this study was to assess the safety and efficacy of an investigational eye drop intended for the prevention and treatment of inflammation (swelling and redness) and pain in the eye after cataract extraction.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cataract
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
2120 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Nepafenac 0.3%
Arm Type
Experimental
Arm Description
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 dose was administered between 30-120 minutes prior to surgery.
Arm Title
NEVANAC
Arm Type
Active Comparator
Arm Description
Nepafenac Ophthalmic Suspension, 0.1%, one drop in affected eye three times daily, beginning one day prior to surgery, continuing on the day of surgery, and for 14 days following surgery.
Arm Title
Nepafenac Vehicle 0.3%
Arm Type
Placebo Comparator
Arm Description
Nepafenac Ophthalmic Suspension 0.3% Vehicle, 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 dose was administered between 30-120 minutes prior to surgery.
Arm Title
NEVANAC Vehicle
Arm Type
Placebo Comparator
Arm Description
Nepafenac 0.1% vehicle, one drop in affected eye three times daily, beginning one day prior to surgery, continuing on the day of surgery, and for 14 days following surgery.
Intervention Type
Drug
Intervention Name(s)
Nepafenac Ophthalmic Suspension, 0.3%
Intervention Description
Nepafenac Ophthalmic Suspension, 0.3%, one drop in affected eye once daily, for 16 days. An additional dose was administered between 30-120 minutes prior to surgery.
Intervention Type
Drug
Intervention Name(s)
Nepafenac Ophthalmic Suspension, 0.1%
Other Intervention Name(s)
NEVANAC®
Intervention Description
Nepafenac Ophthalmic Suspension, 0.1%, one drop in affected eye three times daily, for 16 days
Intervention Type
Other
Intervention Name(s)
Nepafenac Ophthalmic Suspension 0.3% Vehicle
Intervention Description
Nepafenac 0.3% vehicle, one drop in affected eye once daily, for 16 days. An additional dose was administered between 30-120 minutes prior to surgery.
Intervention Type
Other
Intervention Name(s)
NEVANAC Vehicle
Intervention Description
Nepafenac vehicle, one drop in affected eye three times daily, for 16 days
Primary Outcome Measure Information:
Title
Percentage of Patients Cured at Day 14
Description
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 cells and flare.
Time Frame
Day 14
Secondary Outcome Measure Information:
Title
Percentage of Patients Pain-Free at Day 14
Description
Ocular pain as assessed by the investigator on a scale ranging from 0 (none) to 5 (severe). Pain-free was defined as a score of 0 on the investigator's assessment of ocular pain.
Time Frame
Day 14
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Dana Sager, MS
Organizational Affiliation
Alcon Research
Official's Role
Study Director
Facility Information:
Facility Name
Contact Alcon Call Center For Trial Locations
City
Fort Worth
State/Province
Texas
ZIP/Postal Code
76134
Country
United States
12. IPD Sharing Statement
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Confirmatory Study Nepafenac 0.3%
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