Back to resultsNepafenac Compared to Placebo for Ocular Pain and Inflammation
Primary Purpose
Cataract
Status
Completed
Phase
Phase 3
Locations
China
Study Type
Interventional
Intervention
Nepafenac Ophthalmic Suspension, 0.1%
Nepafenac Vehicle Ophthalmic Solution
Sponsored by
About this trial
This is an interventional treatment trial for Cataract focused on measuring Cataract Surgery, Anti-ocular Inflammation, Anti-ocular Pain
Eligibility Criteria
Inclusion Criteria:
- Adult Chinese subjects, 18 years of age or older, of either sex who have a cataract, and are expected to undergo cataract extraction with the implantation of a posterior chamber intraocular lens;
- Study eye of subjects, who in the opinion of the Investigator, will have improvement in best-corrected visual acuity after surgery;
- Subjects should be able to understand and sign an informed consent that has been approved by an Independent Ethics Committee;
- Other protocol-defined inclusion criteria may apply.
Exclusion Criteria:
- Use of topical ocular or systemic steroids within 14 days prior to surgery;
- Use of topical ocular or systemic non-steroidal anti-inflammatory drugs within 7 days of surgery, except an allowed daily dose of baby aspirin (81 mg);
- Subjects planning to have cataract surgery in their fellow, non-study eye prior to the 14 day postoperative study visit;
- Any intraocular inflammation or ocular pain greater than Grade 0 in the study eye that is present during the baseline slit-lamp exam;
Women of childbearing potential (those who are not surgically sterilized or post menopausal) may not participate in the study if any of the following conditions exist:
- they are breast feeding;
- they have a positive urine pregnancy test at baseline;
- they are not willing to undergo a urine pregnancy test upon exiting the study;
- they intend to become pregnant during the duration of the study; or,
- they do not agree to using adequate birth control methods for the duration of the study.
- Any abnormality that prevents reliable tonometry;
- Planned multiple procedures during cataract/IOL implantation surgery;
- Lens pseudoexfoliation syndrome with glaucoma or zonular compromise;
- Previous ocular trauma to the operative eye;
- A history of chronic or recurrent inflammatory eye disease;
- Ocular infection or ocular pain;
- Proliferative diabetic retinopathy;
- Uncontrolled diabetes mellitus;
- Congenital ocular anomaly;
- Iris atrophy in the operative eye;
- A nonfunctional fellow eye;
- Use of an investigational intraocular lens;
- Participation in any other clinical study within 30 days before surgery;
- Known or suspected allergy or hypersensitivity to non-steroidal anti-inflammatory agents, or to any component of the study medication;
- Subjects with known bleeding tendencies, or who are receiving medications that may prolong bleeding time, may be enrolled at the physician's discretion; continuation of previous therapy for these subjects will be left to the judgment of the physician;
- The fellow eye of an individual currently or previously enrolled in the study;
- Subjects using a topical ophthalmic prostaglandin;
- Subjects, who in the opinion of the investigator, might be at increased risk of complications from topical NSAIDs;
- Other protocol-defined exclusion criteria may apply.
Sites / Locations
- Zhongshan Ophthalmic Center, Sun Yat-sen University
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Placebo Comparator
Arm Label
Nepafenac
Placebo
Arm Description
Nepafenac Ophthalmic Suspension, 0.1%, 1 drop to the operative eye, 3 times a day, beginning 1 day preoperatively and continuing through the day of surgery and for 14 days postoperatively. An additional dose was administered prior to surgery.
Nepafenac Vehicle, 1 drop to the operative eye, 3 times a day, beginning 1 day preoperatively and continuing through the day of surgery and for 14 days postoperatively. An additional dose was administered prior to surgery.
Outcomes
Primary Outcome Measures
Proportion of Subjects With Clinical Cure 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 aqueous cells and aqueous flare. The proportion of subjects with a clinical cure is reported as percentage.
Secondary Outcome Measures
Proportion of Subjects Who Were Pain-Free at All Postoperative Visits
Ocular pain is defined as a positive sensation of the eye, including foreign body sensation, stabbing, throbbing, or aching. The Investigator scored ocular pain based on the description of pain by the subject. Pain was scored on a 6-unit scale ranging from 0 (none, absence of positive sensation) to 5 (severe, subject reports intense ocular, periocular or radiating pain requiring prescription analgesic). To be considered pain-free at all post operative visits, the patient must have had a score of 0 at Days 1, 3, 7, and 14 and any unscheduled visit. The proportion of subjects who were pain-free at all post-operative visits is reported as percentage.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01426854
Brief Title
Nepafenac Compared to Placebo for Ocular Pain and Inflammation
Official Title
Clinical Evaluation of Safety and Efficacy of Nepafenac Ophthalmic Suspension, 0.1% Compared to Placebo for the Prevention and Treatment of Ocular Inflammation and Pain Associated With Cataract Surgery in Adult Chinese Subjects
Study Type
Interventional
2. Study Status
Record Verification Date
May 2013
Overall Recruitment Status
Completed
Study Start Date
July 2011 (undefined)
Primary Completion Date
April 2012 (Actual)
Study Completion Date
April 2012 (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 demonstrate that Nepafenac Ophthalmic Suspension, 0.1% is superior to Nepafenac Vehicle (placebo) for the prevention and treatment of ocular inflammation and pain associated with cataract surgery in Chinese subjects.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cataract
Keywords
Cataract Surgery, Anti-ocular Inflammation, Anti-ocular Pain
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
260 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Nepafenac
Arm Type
Active Comparator
Arm Description
Nepafenac Ophthalmic Suspension, 0.1%, 1 drop to the operative eye, 3 times a day, beginning 1 day preoperatively and continuing through the day of surgery and for 14 days postoperatively. An additional dose was administered prior to surgery.
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Nepafenac Vehicle, 1 drop to the operative eye, 3 times a day, beginning 1 day preoperatively and continuing through the day of surgery and for 14 days postoperatively. An additional dose was administered prior to surgery.
Intervention Type
Drug
Intervention Name(s)
Nepafenac Ophthalmic Suspension, 0.1%
Intervention Description
Topical ocular administration
Intervention Type
Other
Intervention Name(s)
Nepafenac Vehicle Ophthalmic Solution
Intervention Description
Inactive ingredients used as placebo; topical ocular administration
Primary Outcome Measure Information:
Title
Proportion of Subjects With Clinical Cure 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 aqueous cells and aqueous flare. The proportion of subjects with a clinical cure is reported as percentage.
Time Frame
Day 14 postoperative
Secondary Outcome Measure Information:
Title
Proportion of Subjects Who Were Pain-Free at All Postoperative Visits
Description
Ocular pain is defined as a positive sensation of the eye, including foreign body sensation, stabbing, throbbing, or aching. The Investigator scored ocular pain based on the description of pain by the subject. Pain was scored on a 6-unit scale ranging from 0 (none, absence of positive sensation) to 5 (severe, subject reports intense ocular, periocular or radiating pain requiring prescription analgesic). To be considered pain-free at all post operative visits, the patient must have had a score of 0 at Days 1, 3, 7, and 14 and any unscheduled visit. The proportion of subjects who were pain-free at all post-operative visits is reported as percentage.
Time Frame
Up to Day 14
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Adult Chinese subjects, 18 years of age or older, of either sex who have a cataract, and are expected to undergo cataract extraction with the implantation of a posterior chamber intraocular lens;
Study eye of subjects, who in the opinion of the Investigator, will have improvement in best-corrected visual acuity after surgery;
Subjects should be able to understand and sign an informed consent that has been approved by an Independent Ethics Committee;
Other protocol-defined inclusion criteria may apply.
Exclusion Criteria:
Use of topical ocular or systemic steroids within 14 days prior to surgery;
Use of topical ocular or systemic non-steroidal anti-inflammatory drugs within 7 days of surgery, except an allowed daily dose of baby aspirin (81 mg);
Subjects planning to have cataract surgery in their fellow, non-study eye prior to the 14 day postoperative study visit;
Any intraocular inflammation or ocular pain greater than Grade 0 in the study eye that is present during the baseline slit-lamp exam;
Women of childbearing potential (those who are not surgically sterilized or post menopausal) may not participate in the study if any of the following conditions exist:
they are breast feeding;
they have a positive urine pregnancy test at baseline;
they are not willing to undergo a urine pregnancy test upon exiting the study;
they intend to become pregnant during the duration of the study; or,
they do not agree to using adequate birth control methods for the duration of the study.
Any abnormality that prevents reliable tonometry;
Planned multiple procedures during cataract/IOL implantation surgery;
Lens pseudoexfoliation syndrome with glaucoma or zonular compromise;
Previous ocular trauma to the operative eye;
A history of chronic or recurrent inflammatory eye disease;
Ocular infection or ocular pain;
Proliferative diabetic retinopathy;
Uncontrolled diabetes mellitus;
Congenital ocular anomaly;
Iris atrophy in the operative eye;
A nonfunctional fellow eye;
Use of an investigational intraocular lens;
Participation in any other clinical study within 30 days before surgery;
Known or suspected allergy or hypersensitivity to non-steroidal anti-inflammatory agents, or to any component of the study medication;
Subjects with known bleeding tendencies, or who are receiving medications that may prolong bleeding time, may be enrolled at the physician's discretion; continuation of previous therapy for these subjects will be left to the judgment of the physician;
The fellow eye of an individual currently or previously enrolled in the study;
Subjects using a topical ophthalmic prostaglandin;
Subjects, who in the opinion of the investigator, might be at increased risk of complications from topical NSAIDs;
Other protocol-defined exclusion criteria may apply.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Mandy Ye, Director
Organizational Affiliation
Alcon (China) Ophthalmic Product Co., Ltd.
Official's Role
Study Director
Facility Information:
Facility Name
Zhongshan Ophthalmic Center, Sun Yat-sen University
City
Guangzhou
State/Province
Guangdong
ZIP/Postal Code
510060
Country
China
12. IPD Sharing Statement
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Nepafenac Compared to Placebo for Ocular Pain and Inflammation
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