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
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.

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
Refractive Errors
Eye Diseases
Pharmaceutical Solutions
Pharmacologic Actions
Therapeutic Uses

ClinicalTrials.gov processed this record on October 29, 2014