Nevanac 3-Month Safety Study With QID Dosing

NCT ID: NCT00332774

Last Updated: 2012-03-05

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

149 participants

Study Classification

INTERVENTIONAL

Study Start Date

2006-02-28

Study Completion Date

2006-12-31

Brief Summary

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The purpose of this study is to determine the safety of Nevanac 0.1% compared to Acular LS 0.4% and Vehicle in patients treated before cataract surgery and for approximately 90 days following surgery.

Detailed Description

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Conditions

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Cataract

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Study Groups

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Nevanac

Group Type EXPERIMENTAL

Nepafenac ophthalmic solution 0.1%

Intervention Type DRUG

1 drop 4 times daily for 90 days

Acular

Group Type ACTIVE_COMPARATOR

Ketorolac Tromethamine ophthalmic solution 0.4%

Intervention Type DRUG

1 drop 4 times daily for 90 days

Vehicle

Group Type PLACEBO_COMPARATOR

Nepafenac ophthalmic suspension vehicle

Intervention Type OTHER

Interventions

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Nepafenac ophthalmic solution 0.1%

1 drop 4 times daily for 90 days

Intervention Type DRUG

Ketorolac Tromethamine ophthalmic solution 0.4%

1 drop 4 times daily for 90 days

Intervention Type DRUG

Nepafenac ophthalmic suspension vehicle

Intervention Type OTHER

Other Intervention Names

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1 drop 4 times daily for 14 days after surgery

Eligibility Criteria

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Inclusion Criteria

* Patients of any race or sex ages 10 years or older undergoing cataract extraction with planned implantation of a posterior chamber intraocular lens.

Exclusion Criteria

* Under 10
Minimum Eligible Age

10 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

Principal Investigators

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Stephen Lane

Role: STUDY_DIRECTOR

Medical Monitor

Locations

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Contact Alcon for Trial Locations

Fort Worth, Texas, United States

Site Status

Countries

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United States

Other Identifiers

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C-05-20

Identifier Type: -

Identifier Source: org_study_id

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