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Alcon Multi-Purpose Disinfecting Solution Versus Renu Fresh Multi-Purpose Solution in Symptomatic Contact Lens Wearers

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Alcon Research
ClinicalTrials.gov Identifier:
NCT01187355
First received: August 20, 2010
Last updated: June 26, 2012
Last verified: June 2012
History of Changes
  Purpose

The purpose of this study is to compare two contact lens care solutions in symptomatic wearers of silicone hydrogel contact lenses.


Condition Intervention
Symptomatic Contact Lens Wearers
 Device: FID 114675A Multi-Purpose Disinfecting Solution (MPDS)
Device: renu fresh Multi-Purpose Solution (MPS)
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: SiH MPDS FID 114675A Compared to Renu Fresh MPS in Symptomatic Contact Lens Wearers

Resource links provided by NLM:

MedlinePlus related topics: Eye Wear
U.S. FDA Resources

Further study details as provided by Alcon Research:

Primary Outcome Measures:
  • Likert Statement: When I Use This Solution, I Can Comfortably Wear my Lenses. [ Time Frame: Day 30 ] [ Designated as safety issue: No ]
    As interpreted and reported by the subject on a questionnaire as a single, retrospective evaluation of the last three days of wearing experience. A 5-point Likert scale was used, where 1=strongly disagree, 2=disagree; 3=neither disagree nor agree; 4=agree; 5=strongly agree.


Secondary Outcome Measures:
  • Likert Statement: When I Use This Solution, My Lenses Are Comfortable From Morning Until Evening. [ Time Frame: Day 30 ] [ Designated as safety issue: No ]
    As interpreted and reported by the subject on a questionnaire as a single, retrospective evaluation of the last three days of wearing experience. A 5-point Likert scale was used, where 1=strongly disagree, 2=disagree; 3=neither disagree nor agree; 4=agree; 5=strongly agree.

  • Likert Statement: When I Use This Solution, I Forget I am Wearing my Lenses. [ Time Frame: Day 30 ] [ Designated as safety issue: No ]
    As interpreted and reported by the subject on a questionnaire as a single, retrospective evaluation of the last three days of wearing experience. A 5-point Likert scale was used, where 1=strongly disagree, 2=disagree; 3=neither disagree nor agree; 4=agree; 5=strongly agree.


Enrollment: 591
Study Start Date: July 2010
Study Completion Date: January 2011
Primary Completion Date: January 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Alcon MPDS
MPDS used for 30 days as specified in protocol for contact lens care.
 Device: FID 114675A Multi-Purpose Disinfecting Solution (MPDS)
Investigational multi-purpose disinfecting solution used by subjects as specified in use instructions provided for the care of study contact lenses, 30 days.
Device: Contact lenses
Contact lenses per subject's habitual brand and power worn for 30 days on a daily wear basis.
Active Comparator: renu fresh MPS
MPS used for 30 days as indicated for contact lens care.
 Device: renu fresh Multi-Purpose Solution (MPS)
Commercially available multi-purpose solution used by subjects as indicated for care of study contact lenses, 30 days.
Other Name: renu® fresh™ Multi-Purpose Solution
Device: Contact lenses
Contact lenses per subject's habitual brand and power worn for 30 days on a daily wear basis.

  Eligibility

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

Inclusion Criteria:

  • Symptomatic silicone hydrogel contact lens wearers who wear their lenses daily wear (i.e., disinfect lenses every night).
  • Vision correctable to 20/30 or better with contact lenses.
  • Other protocol-defined inclusion criteria may apply.

Exclusion Criteria:

  • Sensitivity to multi-purpose solutions.
  • Use of any topical ocular OTC or prescribed topical ocular medications.
  • History (6 months) or current ocular infections or ocular inflammatory events.
  • Ocular surgery within the past year.
  • Medical condition or use of medications that cause ocular side effects.
  • Participation in any investigational study within the past 30 days.
  • Other protocol-defined exclusion criteria may apply.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01187355

Locations
United States, Texas
Contact Alcon Call 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: NCT01187355     History of Changes
Other Study ID Numbers: C-09-074
Study First Received: August 20, 2010
Results First Received: June 26, 2012
Last Updated: June 26, 2012
Health Authority: United States: Institutional Review Board

Keywords provided by Alcon Research:
Symptomatic, Contact lens care
Multi-purpose solution

ClinicalTrials.gov processed this record on October 17, 2012