Subjective Comfort With Multipurpose Care Solutions in Soft Contact Lens Wearers

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

Study Overview

• Status: Completed
• Conditions: Refractive Error; Astigmatism; Myopia
• Intervention / Treatment: Device: OPTI-FREE RepleniSH multipurpose solution; Device: Silicone hydrogel contact lenses; Device: ReNu Biotrue multipurpose solution

• Study Type: Interventional
• Enrollment (Actual): 104
• Phase: Not Applicable

Contacts and Locations

Study Locations

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

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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 Names: 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: 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; 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 Names: ReNu Biotrue™

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change From Baseline (Day 0) in Ocular Comfort Rating at Day 14	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.	Baseline (Day 0), Day 14

Collaborators and Investigators

• Sponsor: Alcon Research

Study record dates

Study Major Dates

• Study Start: September 1, 2010
• Primary Completion (Actual): November 1, 2010
• Study Completion (Actual): November 1, 2010

Study Registration Dates

• First Submitted: September 28, 2010
• First Submitted That Met QC Criteria: September 28, 2010
• First Posted (Estimate): September 29, 2010

Study Record Updates

• Last Update Posted (Estimate): November 12, 2012
• Last Update Submitted That Met QC Criteria: October 15, 2012
• Last Verified: October 1, 2012

More Information

Terms related to this study

• Keywords: Soft contact lenses; Multi-purpose Solution
• Additional Relevant MeSH Terms: Eye Diseases; Refractive Errors; Astigmatism; Pharmaceutical Solutions
• Other Study ID Numbers: SMA-09-59