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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Alcon Research
ClinicalTrials.gov Identifier:
NCT01484938
First received: December 1, 2011
Last updated: October 5, 2012
Last verified: October 2012
History of Changes
  Purpose

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 Intervention
Refractive Error
 Device: OPTI-FREE PureMoist

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: 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

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Alcon Research:

Primary Outcome Measures:
  • Mean Change From Baseline (Day 0) in Average Corneal Staining Area at Day 30 [ Time Frame: Baseline (Day 0), Day 30 ] [ Designated as safety issue: Yes ]
    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.

  • Mean Change From Baseline (Day 0) in Total Corneal Staining Type at Day 30 [ Time Frame: Baseline (Day 0), Day 30 ] [ Designated as safety issue: Yes ]
    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.


Enrollment: 175
Study Start Date: February 2011
Study Completion Date: May 2011
Primary Completion Date: May 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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
Other Name: OPTI-FREE PureMoist

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01484938

Locations
United States, Texas
Contact Alcon Call Center for Trial Locations
Fort Worth, Texas, United States, 76134
Sponsors and Collaborators
Alcon Research
Investigators
Study Director: Jami R Kern Alcon Research
  More Information

No publications provided

Responsible Party: Alcon Research
ClinicalTrials.gov Identifier: NCT01484938     History of Changes
Other Study ID Numbers: C-10-017
Study First Received: December 1, 2011
Results First Received: September 6, 2012
Last Updated: October 5, 2012
Health Authority: Netherlands: Independent Ethics Committee

Keywords provided by Alcon Research:
Soft contact lenses
Multi-purpose solution
Corneal staining

Additional relevant MeSH terms:
Refractive Errors
Eye Diseases
Contact Lens Solutions
Disinfectants
 Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on May 16, 2013