Back to resultsNepafenac Opthalmic Suspension 0.1% Compared to Acular LS for Treatment of Inflammation After Cataract Surgery
Primary Purpose
Cataract
Status
Completed
Phase
Phase 3
Locations
United States
Study Type
Interventional
Intervention
Nepafenac Ophthalmic Suspension, 0.1%
Sponsored by
About this trial
This is an interventional treatment trial for Cataract
Eligibility Criteria
Inclusion Criteria: planned cataract extraction with posterior chamber intraocular lens implantation Exclusion Criteria: Under 10
Sites / Locations
- Lehmann Eye Center
Outcomes
Primary Outcome Measures
Percentage of patients who are a clinical success at Day 14 postoperative visit (where a "clinical success" is defined as aqueous cells < grade 1 and aqueous flare = grade 0 at the current visit and all subsequent visits).
Secondary Outcome Measures
Percentage of patients who are clinically cured, clinical successes, treatment failure, clinically significant inflammation
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00333255
Brief Title
Nepafenac Opthalmic Suspension 0.1% Compared to Acular LS for Treatment of Inflammation After Cataract Surgery
Official Title
Preoperative and Postoperative Nevanac 0.1% Compared to Acular LS for the Treatment of Ocular Inflammation Associated With Cataract Surgery
Study Type
Interventional
2. Study Status
Record Verification Date
July 2009
Overall Recruitment Status
Completed
Study Start Date
September 2005 (undefined)
Primary Completion Date
March 2006 (Actual)
Study Completion Date
undefined (undefined)
3. Sponsor/Collaborators
Name of the Sponsor
Alcon Research
4. Oversight
5. Study Description
Brief Summary
The purpose of this study is to compare the effectiveness of Nepafenac Ophthalmic Suspension, 0.1% eye drops to Acular LS eye drops, used before and after cataract surgery, for treating inflammation in the eye.
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
Single
Allocation
Randomized
Enrollment
267 (Actual)
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
Nepafenac Ophthalmic Suspension, 0.1%
Primary Outcome Measure Information:
Title
Percentage of patients who are a clinical success at Day 14 postoperative visit (where a "clinical success" is defined as aqueous cells < grade 1 and aqueous flare = grade 0 at the current visit and all subsequent visits).
Secondary Outcome Measure Information:
Title
Percentage of patients who are clinically cured, clinical successes, treatment failure, clinically significant inflammation
10. Eligibility
Sex
All
Minimum Age & Unit of Time
10 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
planned cataract extraction with posterior chamber intraocular lens implantation
Exclusion Criteria:
Under 10
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Andrew Maxwell
Organizational Affiliation
Study Director
Official's Role
Study Director
Facility Information:
Facility Name
Lehmann Eye Center
City
Nacogdoches
State/Province
Texas
ZIP/Postal Code
76134
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Nepafenac Opthalmic Suspension 0.1% Compared to Acular LS for Treatment of Inflammation After Cataract Surgery
We'll reach out to this number within 24 hrs