Subjective Comfort With Multipurpose Care Solutions in Soft Contact Lens Wearers

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Alcon Research
ClinicalTrials.gov Identifier:
NCT01211535
First received: September 28, 2010
Last updated: October 15, 2012
Last verified: October 2012
  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:


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

  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 April 22, 2014