Vistakon Investigational Multi-purpose Contact Lens Care Solution.

Not Applicable

Completed

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

• Registration Number: NCT01055457
• 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: 2009-11-01
• Study First Submitted: 2010-01-22
• Study First Submitted QC: 2010-01-22
• Study First Posted: 2010-01-25
• Primary Completion: 2010-05-01
• Study Completion: 2010-05-01
• Results First Submitted: 2016-08-10
• Results First Submitted QC: 2016-11-28
• Results First Posted: 2017-01-24
• Status Verified: 2017-08
• Last Update Submitted: 2018-06-18
• Last Update Posted: 2018-06-19

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 315

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 II	contact lens care solution
ReNu MultiPlus Multi-Purpose Solution	ReNu MultiPlus Multi-Purpose Solution	contact lens care solution

Primary Outcome Measures

Name	Time	Method
Slit Lamp Findings (SLF)	Up to 3 months Post Lens Wear	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.
Distance Visual Acuity (LogMAR)	Up to 3 Months Post Lens Wear	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.