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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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:
Pharmaceutical Solutions
Hydrogen Peroxide
Therapeutic Uses
Pharmacologic Actions
Anti-Infective Agents, Local
Anti-Infective Agents

ClinicalTrials.gov processed this record on September 18, 2014