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
Trial Snapshot
- Phase
- Phase 2
- Status
- Completed
- Sponsor
- Alcon Research
- Enrollment
- 1,342
- Locations
- 1
- Primary Endpoint
- Percentage of Patients Cured at Day 14, Nepafenac 0.3% vs. Nepafenac Vehicle 0.3%
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Triple (Participant, Investigator, Outcomes Assessor)
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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.
Arms & Interventions
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.
Intervention: Nepafenac Ophthalmic Suspension, 0.3% (Drug)
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.
Intervention: Nepafenac Ophthalmic Suspension, 0.1% (Drug)
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.
Intervention: Nepafenac Vehicle 0.3% (Other)
Outcomes
Primary Outcomes
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.
Secondary Outcomes
- Percentage of Patients Cured at Day 7, Nepafenac 0.3% vs. Nepafenac 0.1%(Day 7 postoperative)