Phase 2
Completed N=1,342
Nepafenac 0.3% Two Study
Source: ClinicalTrials.gov NCT01318499 ↗Enrolled (actual)
1,342
Serious AEs
0.7%
Results posted
Dec 2012
Primary outcomePrimary: Percentage of Patients Cured at Day 14, Nepafenac 0.3% vs. Nepafenac Vehicle 0.3% — 64.6; 25.0 Percentage of patients
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage of Patients Cured at Day 14, Nepafenac 0.3% vs. Nepafenac Vehicle 0.3% |
64.6; 25.0 | — |
| SECONDARY Percentage of Patients Cured at Day 7, Nepafenac 0.3% vs. Nepafenac 0.1% |
31.3; 30.8 | — |
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.
Data sourced from ClinicalTrials.gov (NCT01318499). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.