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

NCT ID: NCT00405730

Last Updated: 2016-11-18

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

227 participants

Study Classification

INTERVENTIONAL

Study Start Date

2005-11-30

Study Completion Date

2006-07-31

Brief Summary

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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

Detailed Description

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Conditions

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Cataracts

Keywords

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Cataracts

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Outcome Assessors

Study Groups

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Nepafenac

One drop in the study eye 3 times daily for 23 days

Group Type EXPERIMENTAL

Nepafenac 1mg/ml eye drops, suspension

Intervention Type DRUG

One drop in the study eye 3 times daily for 23 days

Ketorolac Trometamol

One drop in the study eye 3 times daily for 23 days

Group Type ACTIVE_COMPARATOR

Ketorolac Trometamol 5 mg/ml eye drops, solution

Intervention Type DRUG

One drop in the study eye 3 times daily for 23 days

Nepafenac Vehicle

One drop in the study eye 3 times daily for 23 days

Group Type PLACEBO_COMPARATOR

Nepafenac vehicle eye drops

Intervention Type OTHER

One drop in the study eye 3 times daily for 23 days

Interventions

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Nepafenac 1mg/ml eye drops, suspension

One drop in the study eye 3 times daily for 23 days

Intervention Type DRUG

Ketorolac Trometamol 5 mg/ml eye drops, solution

One drop in the study eye 3 times daily for 23 days

Intervention Type DRUG

Nepafenac vehicle eye drops

One drop in the study eye 3 times daily for 23 days

Intervention Type OTHER

Eligibility Criteria

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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.

Exclusion Criteria

* Under 18.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Alcon Research

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Bordeaux

Bordeaux, , France

Site Status

Countries

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France

References

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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.

Reference Type RESULT
PMID: 19668532 (View on PubMed)

Other Identifiers

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2005-002647-35

Identifier Type: -

Identifier Source: secondary_id

C-04-65

Identifier Type: -

Identifier Source: org_study_id