Nevanac 3-Month Safety Study With QID Dosing

Cataract Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00332774
• Other study ID #: C-05-20
• Status: Completed
• Phase: Phase 3
• First received: June 1, 2006
• Last updated: March 1, 2012
• Start date: February 2006
• Est. completion date: December 2006

Study information

• Verified date: March 2012
• Source: Alcon Research
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug AdministrationUnited States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 149
• Est. completion date: December 2006
• Est. primary completion date: December 2006
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 10 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Cataract

Intervention

Drug:
• Nepafenac ophthalmic solution 0.1%
1 drop 4 times daily for 90 days
• Ketorolac Tromethamine ophthalmic solution 0.4%
1 drop 4 times daily for 90 days

Other:
• Nepafenac ophthalmic suspension vehicle

Locations

Country	Name	City	State
United States	Contact Alcon for Trial Locations	Fort Worth	Texas

Sponsors (1)

Lead Sponsor	Collaborator
Alcon Research

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Macular thickness
Secondary	contrast sensitivity, corneal staining, VA, IOP, slit-lamp parameters, fundus parameters