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Confirmatory Study Nepafenac 0.3%

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Alcon Research
ClinicalTrials.gov Identifier:
NCT01109173
First received: April 21, 2010
Last updated: November 29, 2012
Last verified: November 2012
  Purpose

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.


Condition Intervention Phase
Cataract
Drug: Nepafenac Ophthalmic Suspension, 0.3%
Drug: Nepafenac Ophthalmic Suspension, 0.1%
Other: Nepafenac Ophthalmic Suspension 0.3% Vehicle
Other: NEVANAC Vehicle
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Clinical Evaluation of Nepafenac Ophthalmic Suspension, 0.3% for Prevention and Treatment of Ocular Inflammation and Pain After Cataract Surgery

Resource links provided by NLM:


Further study details as provided by Alcon Research:

Primary Outcome Measures:
  • Percentage of Patients Cured at Day 14 [ Time Frame: Day 14 ] [ Designated as safety issue: No ]
    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 Outcome Measures:
  • Percentage of Patients Pain-Free at Day 14 [ Time Frame: Day 14 ] [ Designated as safety issue: No ]
    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.


Enrollment: 2120
Study Start Date: June 2010
Primary Completion Date: May 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 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 dose was administered between 30-120 minutes prior to surgery.
Drug: Nepafenac Ophthalmic Suspension, 0.3%
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.
Active Comparator: NEVANAC
Nepafenac Ophthalmic Suspension, 0.1%, one drop in affected eye three times daily, beginning one day prior to surgery, continuing on the day of surgery, and for 14 days following surgery.
Drug: Nepafenac Ophthalmic Suspension, 0.1%
Nepafenac Ophthalmic Suspension, 0.1%, one drop in affected eye three times daily, for 16 days
Other Name: NEVANAC®
Placebo Comparator: Nepafenac Vehicle 0.3%
Nepafenac Ophthalmic Suspension 0.3% Vehicle, 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 dose was administered between 30-120 minutes prior to surgery.
Other: Nepafenac Ophthalmic Suspension 0.3% Vehicle
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.
Placebo Comparator: NEVANAC Vehicle
Nepafenac 0.1% vehicle, one drop in affected eye three times daily, beginning one day prior to surgery, continuing on the day of surgery, and for 14 days following surgery.
Other: NEVANAC Vehicle
Nepafenac vehicle, one drop in affected eye three times daily, for 16 days

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01109173

Locations
United States, Texas
Contact Alcon Call Center For Trial Locations
Fort Worth, Texas, United States, 76134
Sponsors and Collaborators
Alcon Research
Investigators
Study Director: Dana Sager, MS Alcon Research
  More Information

No publications provided

Responsible Party: Alcon Research
ClinicalTrials.gov Identifier: NCT01109173     History of Changes
Other Study ID Numbers: C-09-055
Study First Received: April 21, 2010
Results First Received: November 1, 2012
Last Updated: November 29, 2012
Health Authority: United States: Food and Drug Administration
United States: Institutional Review Board
Hungary: Ministry of Health, Social and Family Affairs
Hungary: Institutional Ethics Committee
Italy: Ministry of Health
Italy: Ethics Committee
Sweden: Institutional Review Board
Sweden: Medical Products Agency
Switzerland: Ethikkommission
Switzerland: Federal Office of Public Health

Additional relevant MeSH terms:
Cataract
Eye Diseases
Lens Diseases
Nepafenac
Analgesics
Analgesics, Non-Narcotic
Anti-Inflammatory Agents
Anti-Inflammatory Agents, Non-Steroidal
Antirheumatic Agents
Central Nervous System Agents
Peripheral Nervous System Agents
Pharmacologic Actions
Physiological Effects of Drugs
Sensory System Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on November 24, 2014