Vistakon Investigational Multi-purpose Contact Lens Care Solution.

Johnson & Johnson Vision Care, Inc.315 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

315

Conditions

Contact Lens Wear

Interventions

Vistakon Investigational Multi-Purpose Solution IIDEVICE

contact lens care solution

ReNu MultiPlus Multi-Purpose SolutionDEVICE

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 (14)

Unnamed facility

Mission Viejo, California, United States

Unnamed facility

Orlando, Florida, United States

Unnamed facility

Tallahassee, Florida, United States

Outcomes

Primary Outcomes

Slit Lamp Findings (SLF)

Slit Lamp Findings were assessed for each subject eye at baseline, 1-day, 1-week, 2-week, 1-month and 3-month follow-up evaluations. SLF consisted of Edema, Corneal Neovascularization, Cornela Staining, Injection, Tarsal Abnormalities and Other findings; each was graded on a 5-likert Scale (Grade: None, Grade 1: Trace, Grade 2: Mild, Grade 3: Moderate and Grade 4: Severe). The number of eyes with Grade 2 or higher across all time points for each SLF variable was reported.

Time frame: Up to 3 months Post Lens Wear

Distance Visual Acuity (LogMAR)

Distance Visual Acuity (LogMAR) was assessed for each subject eye at 1-week, 2-week, 1-month and 3-month follow-up evaluations. The average Visual Acuity (LogMAR) for each time point and lens was reported.

Time frame: Up to 3 Months Post Lens Wear

Data from ClinicalTrials.gov

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