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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

August 20, 2010
June 26, 2012
July 2010
January 2011   (final data collection date for primary outcome measure)
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.
Not Provided
Complete list of historical versions of study NCT01187355 on ClinicalTrials.gov Archive Site
  • 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.
Not Provided
Not Provided
Not Provided
 
Alcon Multi-Purpose Disinfecting Solution Versus Renu Fresh Multi-Purpose Solution in Symptomatic Contact Lens Wearers
SiH MPDS FID 114675A Compared to Renu Fresh MPS in Symptomatic Contact Lens Wearers

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

Not Provided
Interventional
Not Provided
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Supportive Care
Symptomatic Contact Lens Wearers
  • 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: 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.
  • Experimental: Alcon MPDS
    MPDS used for 30 days as specified in protocol for contact lens care.
    Interventions:
    • Device: FID 114675A Multi-Purpose Disinfecting Solution (MPDS)
    • Device: Contact lenses
  • Active Comparator: renu fresh MPS
    MPS used for 30 days as indicated for contact lens care.
    Interventions:
    • Device: renu fresh Multi-Purpose Solution (MPS)
    • Device: Contact lenses
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
591
January 2011
January 2011   (final data collection date for primary outcome measure)

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.
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01187355
C-09-074
No
Alcon Research
Alcon Research
Not Provided
Not Provided
Alcon Research
June 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP