Vistakon Investigational Multi-purpose Contact Lens Care Solution.

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

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Key information

Conditions

Contact Lens Wear

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Mission Viejo, California, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Vistakon Investigational Multi-Purpose Solution II

Device

contact lens care solution

ReNu MultiPlus Multi-Purpose Solution

Device

contact lens care solution

Primary outcomes

Slit Lamp Findings (SLF)

Time frame: 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)

Time frame: 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.

Sponsors and collaborators

Lead sponsor

Johnson & Johnson Vision Care, Inc.

Industry

Registry information

Important dates

Study start: 2009
Primary completion: 2010
Study completion: 2010
First posted: Jan 25, 2010
Registry last updated: Jun 19, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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Completed