Investigational Multi-purpose Contact Lens Care Solution.

Not Applicable

Completed

• Conditions: Contact Lens Wear
• Interventions: Device: Vistakon Investigational Multi-Purpose Solution I; Device: ReNu MultiPlus Multi-Purpose Solution

• Registration Number: NCT01055613
• Lead Sponsor: Johnson & Johnson Vision Care, Inc.

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study Start: 2009-11
• Study First Submitted: 2010-01-22
• Study First Submitted QC: 2010-01-22
• Study First Posted: 2010-01-25
• Primary Completion: 2010-05
• Results First Submitted: 2016-06-07
• Status Verified: 2016-07
• Results First Submitted QC: 2016-07-18
• Results First Posted: 2016-08-31
• Last Update Submitted: 2018-06-18
• Last Update Posted: 2018-06-19

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 312

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Experimental multi-purpose solution	Vistakon Investigational Multi-Purpose Solution I	Multi-purpose contact lens care solution.
ReNu MultiPlus Multi-Purpose Solution	ReNu MultiPlus Multi-Purpose Solution	Multi-purpose contact lens care solution.

Primary Outcome Measures

Name	Time	Method
Slit Lamp Findings	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)	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.