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Safety and Efficacy of an Investigational Multi-Purpose Disinfecting Solution

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Alcon Research
ClinicalTrials.gov Identifier:
NCT01341977
First received: December 9, 2009
Last updated: September 8, 2011
Last verified: September 2011
History of Changes

December 9, 2009
September 8, 2011
November 2009
May 2010   (final data collection date for primary outcome measure)
  • Subjective Acceptance [ Time Frame: Day 90 ] [ Designated as safety issue: Yes ]
    Lens Moisture Subject Rated Likert item
  • Subjective Acceptance [ Time Frame: Day 90 ] [ Designated as safety issue: No ]
    Lens Moisture Subject Rated Likert Item (1-Strongly Agree to 5-Strongly Disagree)
Not Provided
Complete list of historical versions of study NCT01341977 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
Not Provided
 
Safety and Efficacy of an Investigational Multi-Purpose Disinfecting Solution
Safety and Efficacy of an Investigational Multi-Purpose Disinfecting Solution (MPDS)

The purpose of this study is to determine if Alcon MPDS is safe and effective for silicone hydrogel and soft hydrogel contact lens wearers.

The purpose of this study is to determine if Alcon Multi-Purpose Disinfecting Solution (MPDS) is safe and effective for silicone hydrogel and soft hydrogel contact lens wearers.
Interventional
Not Provided
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator, Outcomes Assessor)
Primary Purpose: Supportive Care
Healthy Contact Lens Wearers
  • Device: Alcon MPDS
    Multi-Purpose Solution intended for use with silicone hydrogel and soft contact lenses
    Other Name: Alcon Multi-Purpose Disinfecting Solution (MPDS)
  • Device: ReNu Fresh MPS
    ReNu Fresh MPS is a marketed product indicated for cleaning, removing protein deposits, rinsing, disinfecting and storage of soft contact lenses.
    Other Name: ReNu Fresh Multi-Purpose Solution (MPS)
  • Experimental: Alcon MPDS
    Alcon Multi-Purpose Disinfecting Solution (MPDS)
    Intervention: Device: Alcon MPDS
  • Active Comparator: ReNu Fresh Multi-Purpose Solution
    ReNu Fresh Multi-Purpose Solution
    Intervention: Device: ReNu Fresh MPS
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
573
May 2010
May 2010   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Silicone hydrogel or soft contact lens wearers who wear their lenses daily wear (i.e. disinfect lenses every night).
  • Patient must be able to read.
  • Vision correctable to 20/30 or better with contact lenses.

Exclusion Criteria:

  • Sensitivity to multi-purpose solutions.
  • Using any topical ocular OTC or prescribed topical ocular medications.
  • History or current ocular infections or ocular inflammatory events.
  • Ocular surgery within the past year.
  • With a medical condition or using medications that cause ocular side effects.
  • Participation in any investigational study within the past 30 days.
Both
Not Provided
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01341977
C-09-026
No
Alcon Research
Alcon Research
Not Provided
Study Director: Jessie M Lemp, MS Alcon Research
Alcon Research
September 2011

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