Subjective Comfort With Multipurpose and Hydrogen Peroxide Lens Care Solutions in Soft Contact Lens Wearers

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Alcon Research
ClinicalTrials.gov Identifier:
NCT01164865
First received: July 15, 2010
Last updated: September 13, 2012
Last verified: September 2012
  Purpose

The purpose of this study was to assess comfort in soft contact lens wearers.


Condition Intervention
Contact Lens Wear
Device: OPTI-FREE RepleniSH multipurpose disinfecting solution
Device: Clear Care contact lens care system
Device: Contact lenses

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Supportive Care
Official Title: The Subjective Comfort With Multipurpose and Hydrogen Peroxide Lens 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 in Ocular Comfort Rating at 2 Weeks [ Time Frame: Baseline (Day 0), 2 weeks ] [ 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."

  • Likert Questionnaire Scores at 2 Weeks [ Time Frame: 2 weeks ] [ Designated as safety issue: No ]
    The Likert Questionnaire included 8 questions on selected comfort measures. All responses were recorded on a 5-point scale, where 1=Strongly Disagree, 2=Disagree, 3=Undecided, 4=Agree, and 5=Strongly Agree.


Enrollment: 78
Study Start Date: June 2010
Study Completion Date: December 2010
Primary Completion Date: December 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: OPTI-FREE RepleniSH
OPTI-FREE RepleniSH multipurpose disinfecting solution used with study contact lenses on a daily basis for 2 weeks.
Device: OPTI-FREE RepleniSH multipurpose disinfecting solution
FDA-approved, multipurpose disinfecting solution used according to provided instructions for cleaning, rinsing, storing, and disinfecting study contact lenses on a daily basis, 2 weeks.
Other Name: OPTI-FREE® RepleniSH®
Device: Contact lenses
Contact lenses per subject's habitual brand and prescription worn every day for the duration of the study, 14 days, on a daily wear basis without scheduled replacement.
Active Comparator: Clear Care
Clear Care contact lens care system used with study contact lenses on a daily basis for 2 weeks.
Device: Clear Care contact lens care system
FDA-approved, hydrogen peroxide-based, lens care system used according to provided instructions for cleaning, disinfecting, daily protein removing, and storage of study contact lenses on a daily basis, 2 weeks.
Other Name: Clear Care®
Device: Contact lenses
Contact lenses per subject's habitual brand and prescription worn every day for the duration of the study, 14 days, on a daily wear basis without scheduled replacement.

  Eligibility

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

Inclusion Criteria:

  • Wear silicone hydrogel contact lenses on a daily wear basis;
  • Currently using OPTI-FREE RepleniSH contact lens solution;
  • Report comfort above 75 on a Visual Analog Scale at the Baseline Visit;
  • Read, sign, and date IRB-approved informed consent and the privacy document;
  • Be generally healthy and have normal ocular health;
  • Be be willing to follow the study procedures and visit schedule;
  • Other protocol-defined inclusion criteria may apply.

Exclusion Criteria:

  • Use of additional lens cleaners;
  • Known sensitivity to any ingredient in either of the test articles;
  • Systemic or ocular disease or disorder (except refractive error) that would negatively affect the conduct or outcome of the study;
  • Prior (within 7 days of enrollment) or current ocular infections;
  • Clinically significant lash or lid abnormality;
  • History of ocular surgery/trauma within the last 6 months;
  • Use of any topical ocular or systemic antibiotics or corticosteroids within 7 days of enrollment;
  • Participation in any other ophthalmic drug or device clinical trial within 30 days of enrollment;
  • Other protocol-defined exclusion criteria may apply.
  Contacts and Locations
No Contacts or Locations Provided
  More Information

No publications provided

Responsible Party: Alcon Research
ClinicalTrials.gov Identifier: NCT01164865     History of Changes
Other Study ID Numbers: SMA-09-58
Study First Received: July 15, 2010
Results First Received: September 13, 2012
Last Updated: September 13, 2012
Health Authority: United States: Institutional Review Board

Keywords provided by Alcon Research:
Soft Contact lens
Multi-Purpose Solution
Hydrogen Peroxide

Additional relevant MeSH terms:
Hydrogen Peroxide
Anti-Infective Agents, Local
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on April 17, 2014