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Nevanac 3-Month Safety Study With QID Dosing

Primary Purpose

Cataract

Status

Completed

Phase

Phase 3

Locations

United States

Study Type

Interventional

Intervention

Nepafenac ophthalmic solution 0.1%

Ketorolac Tromethamine ophthalmic solution 0.4%

Nepafenac ophthalmic suspension vehicle

About this trial

This is an interventional treatment trial for Cataract

Eligibility Criteria

10 Years - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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. Other protocol-defined inclusion criteria may apply. Exclusion Criteria: Under 10 Other protocol-defined exclusion criteria may apply

Sites / Locations

Contact Alcon for Trial Locations

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Active Comparator

Placebo Comparator

Arm Label

Nevanac

Acular

Vehicle

Arm Description

Outcomes

Primary Outcome Measures

Macular thickness

Secondary Outcome Measures

contrast sensitivity, corneal staining, VA, IOP, slit-lamp parameters, fundus parameters

Full Information

NCT ID

NCT00332774

First Posted

June 1, 2006

Last Updated

March 1, 2012

Sponsor

Alcon Research

1. Study Identification

Unique Protocol Identification Number

NCT00332774

Brief Title

Nevanac 3-Month Safety Study With QID Dosing

Official Title

A 3-Month Clinical Safety Comparison of Nevanac 0.1% to Acular LS 0.4% and Vehicle Following Cataract Surgery

Study Type

Interventional

2. Study Status

Record Verification Date

March 2012

Overall Recruitment Status

Completed

Study Start Date

February 2006 (undefined)

Primary Completion Date

December 2006 (Actual)

Study Completion Date

December 2006 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Alcon Research

4. Oversight

5. Study Description

Brief Summary

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Cataract

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 3

Interventional Study Model

Parallel Assignment

Masking

Double

Allocation

Randomized

Enrollment

149 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Nevanac

Arm Type

Experimental

Arm Title

Acular

Arm Type

Active Comparator

Arm Title

Vehicle

Arm Type

Placebo Comparator

Intervention Type

Drug

Intervention Name(s)

Nepafenac ophthalmic solution 0.1%

Intervention Description

1 drop 4 times daily for 90 days

Intervention Type

Drug

Intervention Name(s)

Ketorolac Tromethamine ophthalmic solution 0.4%

Intervention Description

1 drop 4 times daily for 90 days

Intervention Type

Other

Intervention Name(s)

Nepafenac ophthalmic suspension vehicle

Other Intervention Name(s)

1 drop 4 times daily for 14 days after surgery

Primary Outcome Measure Information:

Title

Macular thickness

Secondary Outcome Measure Information:

Title

contrast sensitivity, corneal staining, VA, IOP, slit-lamp parameters, fundus parameters

10. Eligibility

Sex

All

Minimum Age & Unit of Time

10 Years

Accepts Healthy Volunteers

Eligibility Criteria

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Stephen Lane

Organizational Affiliation

Medical Monitor

Official's Role

Study Director

Facility Information:

Facility Name

Contact Alcon for Trial Locations

City

Fort Worth

State/Province

Texas

ZIP/Postal Code

76134

Country

United States

12. IPD Sharing Statement

Learn more about this trial

Nevanac 3-Month Safety Study With QID Dosing

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