Back to resultsLens Wearing Experience and Biocompatibility of a Marketed Multi-Purpose Disinfecting Solution in Silicone Hydrogel and Soft Contact Lens Wearers
Primary Purpose
Refractive Error
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
OPTI-FREE PureMoist
Sponsored by
About this trial
This is an interventional supportive care trial for Refractive Error focused on measuring Soft contact lenses, Multi-purpose solution, Corneal staining
Eligibility 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
Sites / Locations
- Contact Alcon Call Center for Trial Locations
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
OPTI-FREE
Arm Description
OPTI-FREE PureMoist multi-purpose contact lens solution used for cleaning, rinsing, disinfecting/storing, and reinserting contact lenses, per protocol-specified regimen
Outcomes
Primary Outcome Measures
Mean Change From Baseline (Day 0) in Average Corneal Staining Area at 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.
Mean Change From Baseline (Day 0) in Total Corneal Staining Type at 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.
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01484938
Brief Title
Lens Wearing Experience and Biocompatibility of a Marketed Multi-Purpose Disinfecting Solution in Silicone Hydrogel and Soft Contact Lens Wearers
Official Title
Lens Wearing Experience and Biocompatibility of a Marketed Multi-Purpose Disinfecting Solution in Silicone Hydrogel and Soft Contact Lens Wearers
Study Type
Interventional
2. Study Status
Record Verification Date
October 2012
Overall Recruitment Status
Completed
Study Start Date
February 2011 (undefined)
Primary Completion Date
May 2011 (Actual)
Study Completion Date
May 2011 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Alcon Research
4. Oversight
Data Monitoring Committee
No
5. Study Description
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).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Refractive Error
Keywords
Soft contact lenses, Multi-purpose solution, Corneal staining
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
175 (Actual)
8. Arms, Groups, and Interventions
Arm Title
OPTI-FREE
Arm Type
Experimental
Arm Description
OPTI-FREE PureMoist multi-purpose contact lens solution used for cleaning, rinsing, disinfecting/storing, and reinserting contact lenses, per protocol-specified regimen
Intervention Type
Device
Intervention Name(s)
OPTI-FREE PureMoist
Intervention Description
Commercially marketed multi-purpose contact lens solution for cleaning, rinsing, disinfecting/storing, and reinserting contact lenses
Primary Outcome Measure Information:
Title
Mean Change From Baseline (Day 0) in Average Corneal Staining Area at Day 30
Description
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.
Time Frame
Baseline (Day 0), Day 30
Title
Mean Change From Baseline (Day 0) in Total Corneal Staining Type at Day 30
Description
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.
Time Frame
Baseline (Day 0), Day 30
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jami R Kern
Organizational Affiliation
Alcon Research
Official's Role
Study Director
Facility Information:
Facility Name
Contact Alcon Call Center for Trial Locations
City
Fort Worth
State/Province
Texas
ZIP/Postal Code
76134
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Lens Wearing Experience and Biocompatibility of a Marketed Multi-Purpose Disinfecting Solution in Silicone Hydrogel and Soft Contact Lens Wearers
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