Investigational Multi-purpose Contact Lens Care Solution.

Johnson & Johnson Vision Care, Inc.0 sites312 target enrollmentNovember 2009

ConditionsContact Lens Wear

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Contact Lens Wear
Sponsor: Johnson & Johnson Vision Care, Inc.
Enrollment: 312
Primary Endpoint: Slit Lamp Findings
Status: Completed
Last Updated: 7 years ago

Overview Investigators Eligibility Criteria Outcomes Similar Trials

Overview

Brief Summary

This study compares an investigational contact lens care multi-purpose solution to a currently marketed multi-purpose solution.

Registry

clinicaltrials.gov

Start Date

November 2009

End Date

May 2010

Last Updated

7 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Johnson & Johnson Vision Care, Inc.

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•must be an adapted contact lens wearer
•best corrected distance visual acuity must be 20/25 or better in each eye
•must be wearing their habitual lenses on a daily wear basis
•must be willing to refrain from swimming during the study

Exclusion Criteria

•any systemic diseases that may interfere with contact lens wear
•any clinically significant ocular disease
•any ocular infection
•use of certain medications
•any grade 2 or greater slit lamp findings
•any know sensitivity to marketed contact lens care solutions
•currently pregnant or lactating
•monovision corrected

Outcomes

Primary Outcomes

Slit Lamp Findings

Time Frame: 3 months

Each subjects' eye was examined using a bio-microscope. Slit lamp findings were graded with a 5-point scale (i.e. Grade 0= None, Grade 1 = trace, Grade 2 = Mild, Grade 3 = moderate and Grade 4 = severe). The number of eyes with Grade 3 or higher for each lens was reported for each assessment.

Distance Visual Acuity (LogMAR)

Time Frame: Up to 3 Months

Distance visual acuity was collected at the 1-, 2-, 3-week and 1- and 3- month follow-up evaluations. The average LogMAR across all visits for each lens type was reported.