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Nepafenac 0.3% Two Study

Information source: Alcon Research
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Cataract

Intervention: Nepafenac Ophthalmic Suspension, 0.3% (Drug); Nepafenac Ophthalmic Suspension, 0.1% (Drug); Nepafenac Vehicle 0.3% (Other)

Phase: Phase 2

Status: Completed

Sponsored by: Alcon Research

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.

Clinical Details

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 design: Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Primary outcome: Percentage of Patients Cured at Day 14, Nepafenac 0.3% vs. Nepafenac Vehicle 0.3%

Secondary outcome: Percentage of Patients Cured at Day 7, Nepafenac 0.3% vs. Nepafenac 0.1%

Eligibility

Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.

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.

Locations and Contacts

Contact Alcon Call Center for Trial Locations, Fort Worth, Texas 76134, United States
Additional Information

Starting date: March 2011
Last updated: December 14, 2012

Page last updated: August 23, 2015

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