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OpenTrials
Completed

NCT Number: NCT01109173

Confirmatory Study Nepafenac 0.3%

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Contact Alcon Call Center For Trial Locations

Fort Worth, Texas, 76134, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Nepafenac Ophthalmic Suspension, 0.3%

Drug

Nepafenac Ophthalmic Suspension, 0.3%, one drop in affected eye once daily, for 16 days. An additional dose was administered between 30-120 minutes prior to surgery.

Nepafenac Ophthalmic Suspension, 0.1%

Drug

Nepafenac Ophthalmic Suspension, 0.1%, one drop in affected eye three times daily, for 16 days

Other names: NEVANAC®

Nepafenac Ophthalmic Suspension 0.3% Vehicle

Other

Nepafenac 0.3% vehicle, one drop in affected eye once daily, for 16 days. An additional dose was administered between 30-120 minutes prior to surgery.

NEVANAC Vehicle

Other

Nepafenac vehicle, one drop in affected eye three times daily, for 16 days

Primary outcomes

  1. Percentage of Patients Cured at Day 14

    Time frame: Day 14

    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 cells and flare.

Secondary outcomes

  1. Percentage of Patients Pain-Free at Day 14

    Time frame: Day 14

    Ocular pain as assessed by the investigator on a scale ranging from 0 (none) to 5 (severe). Pain-free was defined as a score of 0 on the investigator's assessment of ocular pain.

Sponsors and collaborators

Lead sponsor

Alcon Research

Industry

Registry information

Official study title

Clinical Evaluation of Nepafenac Ophthalmic Suspension, 0.3% for Prevention and Treatment of Ocular Inflammation and Pain After Cataract Surgery

Important dates

Study start
2010
Primary completion
2011
First posted
Apr 23, 2010
Registry last updated
Nov 30, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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