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

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

Condition(s) targeted: Cataracts

Intervention: Nepafenac 1mg/ml eye drops, suspension (Drug); Ketorolac Trometamol 5 mg/ml eye drops, solution (Drug); Nepafenac vehicle eye drops (Other)

Phase: Phase 3

Status: Completed

Sponsored by: Alcon Research

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

Clinical Details

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

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

Primary outcome: Percentage of Patients with Day 14 Cure

Eligibility

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

Criteria:

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.

Locations and Contacts

Bordeaux, Bordeaux 33000, France
Additional Information

Starting date: November 2005
Last updated: April 3, 2012

Page last updated: August 23, 2015

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