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Confirmatory Study Nepafenac 0.3%

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 Ophthalmic Suspension 0.3% Vehicle (Other); NEVANAC Vehicle (Other)

Phase: Phase 3

Status: Completed

Sponsored by: Alcon Research

Official(s) and/or principal investigator(s):
Dana Sager, MS, Study Director, Affiliation: Alcon Research

Summary

The purpose of this study was to assess the safety and efficacy of an investigational eye drop intended 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% for Prevention and Treatment of Ocular Inflammation and Pain After 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

Secondary outcome: Percentage of Patients Pain-Free at Day 14

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: June 2010
Last updated: November 29, 2012

Page last updated: August 23, 2015

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