Nepafenac 0.1% Eye Drops, Suspension Compared to Ketorolac Trometamol 0.5% Eye Drops, Solution and Placebo

Cataracts Clinical Trial

Official title:

Nepafenac 0.1% Eye Drops, Suspension Compared to Ketorolac Trometamol 0.5% Eye Drops, Solution and Placebo (Nepafenac Vehicle) for the Prevention and Treatment of Ocular Inflammation and Ocular Pain Associated With Cataract Surgery: European Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00405730
• Other study ID #: C-04-65
• Secondary ID: 2005-002647-35
• Status: Completed
• Phase: Phase 3
• First received: November 29, 2006
• Last updated: November 16, 2016
• Start date: November 2005
• Est. completion date: July 2006

Study information

• Verified date: April 2012
• Source: Alcon Research
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
• Study type: Interventional

Clinical Trial Summary

To evaluate the safety and efficacy of Nepafenac 1 mg/ml Eye Drops, Suspension, compared to Placebo and Ketorolac Trometamol 5 mg/ml Eye Drops, Solution for the prevention and treatment of ocular inflammation and ocular pain after cataract extraction with IOL implantation

Recruitment information / eligibility

• Status: Completed
• Enrollment: 227
• Est. completion date: July 2006
• Est. primary completion date: July 2006
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Patients (18 years or older) of any race and either sex, requiring cataract extraction with planned implantation of a posterior chamber intraocular lens.

• Other protocol-defined inclusion criteria may apply.

Exclusion Criteria:

• Under 18.

• Other protocol-defined exclusion criteria may apply.

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Cataract
• Cataracts

Intervention

Drug:
• Nepafenac 1mg/ml eye drops, suspension
One drop in the study eye 3 times daily for 23 days
• Ketorolac Trometamol 5 mg/ml eye drops, solution
One drop in the study eye 3 times daily for 23 days

Other:
• Nepafenac vehicle eye drops
One drop in the study eye 3 times daily for 23 days

Locations

Country	Name	City	State
France	Bordeaux	Bordeaux

Sponsors (1)

Lead Sponsor	Collaborator
Alcon Research

Country where clinical trial is conducted

France, 

References & Publications (1)

Nardi M, Lobo C, Bereczki A, Cano J, Zagato E, Potts S, Sullins G, Notivol R. Analgesic and anti-inflammatory effectiveness of nepafenac 0.1% for cataract surgery. Clin Ophthalmol. 2007 Dec;1(4):527-33. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Percentage of Patients with Day 14 Cure	Cure is defined as aqueous cells score = 0 and aqueous cells score = 0 at Day 14.	Day 14	Yes