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 in Symptomatic Patients

Alcon Research1 site in 1 country362 target enrollmentAugust 2004

ConditionsContact Lens Care

Overview

Phase: N/A
Intervention: Not specified
Conditions: Contact Lens Care
Sponsor: Alcon Research
Enrollment: 362
Locations: 1
Primary Endpoint: Efficacy:
Status: Completed
Last Updated: 13 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 in patients who experience discomfort with their contact lenses.

Registry

clinicaltrials.gov

Start Date

August 2004

End Date

February 2005

Last Updated

13 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Alcon Research

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•Symptomatic for contact lens related discomfort at the end of the lens wearing day.
•Successful daily wear of FDA Group IV lenses on a two-week or longer replacement schedule for at least two weeks.
•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 4 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.