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Lens Wearing Experience and Biocompatibility of a Marketed Multi-Purpose Disinfecting Solution in Silicone Hydrogel and Soft Contact Lens Wearers

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ClinicalTrials.gov Identifier: NCT01484938
Recruitment Status : Completed
First Posted : December 5, 2011
Results First Posted : October 8, 2012
Last Update Posted : October 10, 2012
Sponsor:
Information provided by (Responsible Party):
Alcon Research

Study Description
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Brief Summary:
The purpose of this study was to describe mean differences in corneal staining (type and area) for OPTI-FREE PureMoist Multi-Purpose Disinfecting Solution (MPDS) at Day 30 compared to Baseline (Day 0).

Condition or disease Intervention/treatment Phase
Refractive Error Device: OPTI-FREE PureMoist Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 175 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
Official Title: Lens Wearing Experience and Biocompatibility of a Marketed Multi-Purpose Disinfecting Solution in Silicone Hydrogel and Soft Contact Lens Wearers
Study Start Date : February 2011
Actual Primary Completion Date : May 2011
Actual Study Completion Date : May 2011

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Arms and Interventions
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Arm Intervention/treatment
Experimental: OPTI-FREE
OPTI-FREE PureMoist multi-purpose contact lens solution used for cleaning, rinsing, disinfecting/storing, and reinserting contact lenses, per protocol-specified regimen
 Device: OPTI-FREE PureMoist
Commercially marketed multi-purpose contact lens solution for cleaning, rinsing, disinfecting/storing, and reinserting contact lenses


Outcome Measures
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Primary Outcome Measures :
  1. Mean Change From Baseline (Day 0) in Average Corneal Staining Area at Day 30 [ Time Frame: Baseline (Day 0), Day 30 ]
    Percentage corneal staining was assessed by the investigator for each of five regions of the cornea; i.e., four quadrants plus central. The investigator instilled flourescein dye and examined the cornea with a slit lamp, i.e., biomicroscope and yellow filter. Percentage corneal staining was recorded in increments of ten, and the percentages of the five regions were averaged together.

  2. Mean Change From Baseline (Day 0) in Total Corneal Staining Type at Day 30 [ Time Frame: Baseline (Day 0), Day 30 ]
    Corneal staining type was assessed by the investigator for each of five regions of the cornea, i.e., four quadrants plus central. The investigator instilled flourescein dye and examined the cornea with a slit lamp, i.e., biomicroscope and yellow filter. Corneal staining type was recorded on a 5-point scale for each region: 0=none; 1=micropunctate; 2=macropunctate; 3=coalesced macropunctate; 4=patch (>/= 1 mm). The five regions were summed, for a summed total range of 0-20.


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 18 years or older
  • Soft contact lens wear on a daily wear basis
  • Able to wear contact lenses for at least 8 hours
  • Generally healthy and have normal ocular health
  • Other protocol-defined inclusion criteria may apply

Exclusion Criteria:

  • No use of additional lens cleaners
  • No known sensitivities to any ingredient in the test article
  • No history of ocular surgery/trauma within the last six months
  • Other protocol-defined exclusion criteria may apply
Contacts and Locations
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To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01484938


Locations
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United States, Texas
Contact Alcon Call Center for Trial Locations
Fort Worth, Texas, United States, 76134
Sponsors and Collaborators
Alcon Research
Investigators
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Study Director: Jami R Kern Alcon Research
More Information
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Responsible Party: Alcon Research
ClinicalTrials.gov Identifier: NCT01484938    
Other Study ID Numbers: C-10-017
First Posted: December 5, 2011    Key Record Dates
Results First Posted: October 8, 2012
Last Update Posted: October 10, 2012
Last Verified: October 2012
Keywords provided by Alcon Research:
Soft contact lenses
Multi-purpose solution
Corneal staining
Additional relevant MeSH terms:
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Refractive Errors
Eye Diseases