Back to resultsNepafenac 0.3% Two Study
Primary Purpose
Cataract
Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Nepafenac Ophthalmic Suspension, 0.3%
Nepafenac Ophthalmic Suspension, 0.1%
Nepafenac Vehicle 0.3%
Sponsored by
About this trial
This is an interventional treatment trial for Cataract focused on measuring cataract, inflammation, pain, inflammatory cells, aqueous flare
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 Type
Experimental
Active Comparator
Placebo Comparator
Arm Label
Nepafenac 0.3%
Nepafenac 0.1%
Nepafenac Vehicle 0.3%
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 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, 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, 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.
Outcomes
Primary Outcome Measures
Percentage of Patients Cured at Day 14, Nepafenac 0.3% vs. Nepafenac Vehicle 0.3%
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.
Secondary Outcome Measures
Percentage of Patients Cured at Day 7, Nepafenac 0.3% vs. Nepafenac 0.1%
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.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01318499
Brief Title
Nepafenac 0.3% Two Study
Official Title
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
Study Type
Interventional
2. Study Status
Record Verification Date
December 2012
Overall Recruitment Status
Completed
Study Start Date
March 2011 (undefined)
Primary Completion Date
September 2011 (Actual)
Study Completion Date
September 2011 (Actual)
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 Nepafenac Ophthalmic Suspension, 0.3% 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
Keywords
cataract, inflammation, pain, inflammatory cells, aqueous flare
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
1342 (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 drop was administered between 30-120 minutes prior to surgery.
Arm Title
Nepafenac 0.1%
Arm Type
Active Comparator
Arm Description
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.
Arm Title
Nepafenac Vehicle 0.3%
Arm Type
Placebo Comparator
Arm Description
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.
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 drop 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 once daily, for 16 days. An additional drop was administered between 30-120 minutes prior to surgery.
Intervention Type
Other
Intervention Name(s)
Nepafenac Vehicle 0.3%
Intervention Description
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.
Primary Outcome Measure Information:
Title
Percentage of Patients Cured at Day 14, Nepafenac 0.3% vs. Nepafenac Vehicle 0.3%
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 aqueous cells and aqueous flare.
Time Frame
Day 14 postoperative
Secondary Outcome Measure Information:
Title
Percentage of Patients Cured at Day 7, Nepafenac 0.3% vs. Nepafenac 0.1%
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 aqueous cells and aqueous flare.
Time Frame
Day 7 postoperative
Other Pre-specified Outcome Measures:
Title
Cumulative Percentage of Patients Cured by Visit
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 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.
Time Frame
Day 1, Day 3, Day 7, Day 14
Title
Cumulative Percentage of Patients Pain Free by Visit
Description
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.
Time Frame
Day 1, Day 3, Day 7, 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.
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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Nepafenac 0.3% Two Study
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