Subjective Comfort With Multipurpose Care Solutions in Soft Contact Lens Wearers - Full Text View

Purpose

The purpose of this study was to assess the comfort of OPTI-FREE RepleniSH in soft contact lens wearers.

Condition	Intervention
Myopia Astigmatism Refractive Error	Device: OPTI-FREE RepleniSH multipurpose solution Device: ReNu Biotrue multipurpose solution Device: Silicone hydrogel contact lenses

Study Type:	Interventional
Study Design:	Allocation: Randomized Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Investigator) Primary Purpose: Supportive Care
Official Title:	Subjective Comfort With Multipurpose Care Solutions in Soft Contact Lens Wearers

Resource links provided by NLM:

MedlinePlus related topics: Eye Wear Refractive Errors

U.S. FDA Resources

Further study details as provided by Alcon Research:

Primary Outcome Measures:

Change From Baseline (Day 0) in Ocular Comfort Rating at Day 14 [ Time Frame: Baseline (Day 0), Day 14 ] [ Designated as safety issue: No ]
Ocular comfort was rated by the participant on a continuous visual analog scale from 0-100, where 0=extremely uncomfortable, 50=neither comfortable nor uncomfortable, and 100=extremely comfortable. The participant marked a horizontal line across the scale at the point that best described, "how your eyes feel right now." A positive number indicates increased ocular comfort; a negative number indicates decreased ocular comfort.

Enrollment:	104
Study Start Date:	September 2010
Study Completion Date:	November 2010
Primary Completion Date:	November 2010 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: OPTI-FREE RepleniSH OPTI-FREE RepleniSH multipurpose solution used with study contact lenses on a daily wear basis for 14 days	Device: OPTI-FREE RepleniSH multipurpose solution FDA-approved, multipurpose solution used as indicated for cleaning, rinsing, conditioning, disinfecting, and storing study contact lenses on a daily wear basis for 14 days Other Name: OPTI-FREE® RepleniSH® Device: Silicone hydrogel contact lenses Silicone hydrogel contact lenses per subject's habitual brand and prescription worn on a daily wear basis for 14 days, with either OPTI-FREE RepleniSH or ReNu Biotrue used for contact lens care
Active Comparator: ReNu Biotrue ReNu Biotrue multipurpose solution used with study contact lenses on a daily wear basis for 14 days	Device: ReNu Biotrue multipurpose solution FDA-approved, multipurpose solution used as indicated for cleaning, disinfecting, daily protein removing, and storing study contact lenses on a daily wear basis for 14 days Other Name: ReNu Biotrue™ Device: Silicone hydrogel contact lenses Silicone hydrogel contact lenses per subject's habitual brand and prescription worn on a daily wear basis for 14 days, with either OPTI-FREE RepleniSH or ReNu Biotrue used for contact lens care

Arms

Assigned Interventions

Experimental: OPTI-FREE RepleniSH

OPTI-FREE RepleniSH multipurpose solution used with study contact lenses on a daily wear basis for 14 days

Device: OPTI-FREE RepleniSH multipurpose solution

FDA-approved, multipurpose solution used as indicated for cleaning, rinsing, conditioning, disinfecting, and storing study contact lenses on a daily wear basis for 14 days

Other Name: OPTI-FREE® RepleniSH®

Device: Silicone hydrogel contact lenses

Silicone hydrogel contact lenses per subject's habitual brand and prescription worn on a daily wear basis for 14 days, with either OPTI-FREE RepleniSH or ReNu Biotrue used for contact lens care

Active Comparator: ReNu Biotrue

ReNu Biotrue multipurpose solution used with study contact lenses on a daily wear basis for 14 days

Device: ReNu Biotrue multipurpose solution

FDA-approved, multipurpose solution used as indicated for cleaning, disinfecting, daily protein removing, and storing study contact lenses on a daily wear basis for 14 days

Other Name: ReNu Biotrue™

Device: Silicone hydrogel contact lenses

Silicone hydrogel contact lenses per subject's habitual brand and prescription worn on a daily wear basis for 14 days, with either OPTI-FREE RepleniSH or ReNu Biotrue used for contact lens care

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Currently wearing silicone hydrogel contact lenses on a daily wear basis;
Currently using OPTI-FREE RepleniSH contact lens solution;
Generally healthy;
Normal ocular health;
Willing to follow study procedures and visit schedule;
Sign Informed Consent and privacy document;
Other protocol-defined inclusion criteria may apply.

Exclusion Criteria:

Use of additional lens cleaners;
Known sensitivities to any ingredient in either test article;
Systemic or ocular disease or disorder that would negatively affect the conduct or outcome of the study;
History of ocular surgery/trauma within the last 6 months;
Any topical ocular or systemic antibiotics within 7 days of enrollment continuing throughout the study;
Participation in any other ophthalmic drug or device clinical trial within 30 days of enrollent;
Other protocol-defined exclusion criteria may apply.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT01211535

Locations

United States, Texas
Contact Alcon Trial Center for Trial Locations
Fort Worth, Texas, United States, 76134

Sponsors and Collaborators

Alcon Research

More Information

No publications provided

Responsible Party:	Alcon Research
ClinicalTrials.gov Identifier:	NCT01211535 History of Changes
Other Study ID Numbers:	SMA-09-59
Study First Received:	September 28, 2010
Results First Received:	October 15, 2012
Last Updated:	October 15, 2012
Health Authority:	United States: Institutional Review Board

Keywords provided by Alcon Research:

Soft contact lenses
Multi-purpose Solution

Additional relevant MeSH terms:

Astigmatism
Myopia
Refractive Errors
Eye Diseases

ClinicalTrials.gov processed this record on May 22, 2013