Investigational Multi-purpose Contact Lens Care Solution.

Johnson & Johnson Vision Care, Inc.312 enrolled

Overview

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

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

TRIPLE

Enrollment

312

Conditions

Contact Lens Wear

Interventions

Vistakon Investigational Multi-Purpose Solution IDEVICE

Multi-purpose contact lens care solution.

ReNu MultiPlus Multi-Purpose SolutionDEVICE

Multi-purpose contact lens care solution

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (15)

Unnamed facility

Fresno, California, United States

Unnamed facility

Pismo Beach, California, United States

Unnamed facility

Louisville, Colorado, United States

Outcomes

Primary Outcomes

Slit Lamp Findings

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.

Time frame: 3 months

Distance Visual Acuity (LogMAR)

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.

Time frame: Up to 3 Months

Data from ClinicalTrials.gov

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