Clinical Evaluation of the Safety and Efficacy of an Investigational Multi-Purpose Disinfecting Solution Compared to a Marketed Multi-Purpose Solution for Care of Soft Contact Lenses

Alcon Research1 site in 1 country252 target enrollmentJuly 2004

ConditionsContact Lens Care

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Contact Lens Care
Sponsor: Alcon Research
Enrollment: 252
Locations: 1
Primary Endpoint: Lens Cleanliness - Residual lens lysozyme (HPLC) at Day 90 on Group IV lenses
Status: Completed
Last Updated: 14 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief Summary

The objective of the study was to clinically evaluate the safety and effectiveness of a new multi-purpose disinfecting solution for soft contact lenses.

Registry

clinicaltrials.gov

Start Date

July 2004

End Date

November 2004

Last Updated

14 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Alcon Research

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•Successful daily wear of FDA Group I or IV lenses on a two-week or longer replacement schedule for at least one month.
•Use of a multi-purpose solution only as the pre-study care regimen for at least one month (rewetting drops use is also acceptable).
•Successful lens wear for at least 8 hours per day.
•Vision correctable to 20/
•Normal eyes - no current ocular abnormalities that prevent successful contact lens wear.
•No corneal surgery within the past 12 months.
•No systemic disease that affects that eye or that could be worsened by the use of contact lenses or solutions.
•No over-the-counter or prescription ocular medication.
•No enrollment in another clinical study within 30 days prior to enrollment.