Back to resultsSubjective Comfort With Multipurpose Care Solutions in Soft Contact Lens Wearers
Primary Purpose
Myopia, Astigmatism, Refractive Error
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
OPTI-FREE RepleniSH multipurpose solution
ReNu Biotrue multipurpose solution
Silicone hydrogel contact lenses
Sponsored by
About this trial
This is an interventional supportive care trial for Myopia focused on measuring Soft contact lenses, Multi-purpose Solution
Eligibility Criteria
Inclusion Criteria:
- Currently wearing silicone hydrogel contact lenses on a daily wear basis;
- Currently using OPTI-FREE RepleniSH contact lens solution;
- Generally healthy;
- Normal ocular health;
- Willing to follow study procedures and visit schedule;
- Sign Informed Consent and privacy document;
- Other protocol-defined inclusion criteria may apply.
Exclusion Criteria:
- Use of additional lens cleaners;
- Known sensitivities to any ingredient in either test article;
- Systemic or ocular disease or disorder that would negatively affect the conduct or outcome of the study;
- History of ocular surgery/trauma within the last 6 months;
- Any topical ocular or systemic antibiotics within 7 days of enrollment continuing throughout the study;
- Participation in any other ophthalmic drug or device clinical trial within 30 days of enrollent;
- Other protocol-defined exclusion criteria may apply.
Sites / Locations
- Contact Alcon Trial Center for Trial Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
OPTI-FREE RepleniSH
ReNu Biotrue
Arm Description
OPTI-FREE RepleniSH multipurpose solution used with study contact lenses on a daily wear basis for 14 days
ReNu Biotrue multipurpose solution used with study contact lenses on a daily wear basis for 14 days
Outcomes
Primary Outcome Measures
Change From Baseline (Day 0) in Ocular Comfort Rating at Day 14
Ocular comfort was rated by the participant on a continuous visual analog scale from 0-100, where 0=extremely uncomfortable, 50=neither comfortable nor uncomfortable, and 100=extremely comfortable. The participant marked a horizontal line across the scale at the point that best described, "how your eyes feel right now." A positive number indicates increased ocular comfort; a negative number indicates decreased ocular comfort.
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01211535
Brief Title
Subjective Comfort With Multipurpose Care Solutions in Soft Contact Lens Wearers
Official Title
Subjective Comfort With Multipurpose Care Solutions in Soft Contact Lens Wearers
Study Type
Interventional
2. Study Status
Record Verification Date
October 2012
Overall Recruitment Status
Completed
Study Start Date
September 2010 (undefined)
Primary Completion Date
November 2010 (Actual)
Study Completion Date
November 2010 (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 assess the comfort of OPTI-FREE RepleniSH in soft contact lens wearers.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Myopia, Astigmatism, Refractive Error
Keywords
Soft contact lenses, Multi-purpose Solution
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
104 (Actual)
8. Arms, Groups, and Interventions
Arm Title
OPTI-FREE RepleniSH
Arm Type
Experimental
Arm Description
OPTI-FREE RepleniSH multipurpose solution used with study contact lenses on a daily wear basis for 14 days
Arm Title
ReNu Biotrue
Arm Type
Active Comparator
Arm Description
ReNu Biotrue multipurpose solution used with study contact lenses on a daily wear basis for 14 days
Intervention Type
Device
Intervention Name(s)
OPTI-FREE RepleniSH multipurpose solution
Other Intervention Name(s)
OPTI-FREE® RepleniSH®
Intervention Description
FDA-approved, multipurpose solution used as indicated for cleaning, rinsing, conditioning, disinfecting, and storing study contact lenses on a daily wear basis for 14 days
Intervention Type
Device
Intervention Name(s)
ReNu Biotrue multipurpose solution
Other Intervention Name(s)
ReNu Biotrue™
Intervention Description
FDA-approved, multipurpose solution used as indicated for cleaning, disinfecting, daily protein removing, and storing study contact lenses on a daily wear basis for 14 days
Intervention Type
Device
Intervention Name(s)
Silicone hydrogel contact lenses
Intervention Description
Silicone hydrogel contact lenses per subject's habitual brand and prescription worn on a daily wear basis for 14 days, with either OPTI-FREE RepleniSH or ReNu Biotrue used for contact lens care
Primary Outcome Measure Information:
Title
Change From Baseline (Day 0) in Ocular Comfort Rating at Day 14
Description
Ocular comfort was rated by the participant on a continuous visual analog scale from 0-100, where 0=extremely uncomfortable, 50=neither comfortable nor uncomfortable, and 100=extremely comfortable. The participant marked a horizontal line across the scale at the point that best described, "how your eyes feel right now." A positive number indicates increased ocular comfort; a negative number indicates decreased ocular comfort.
Time Frame
Baseline (Day 0), Day 14
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Currently wearing silicone hydrogel contact lenses on a daily wear basis;
Currently using OPTI-FREE RepleniSH contact lens solution;
Generally healthy;
Normal ocular health;
Willing to follow study procedures and visit schedule;
Sign Informed Consent and privacy document;
Other protocol-defined inclusion criteria may apply.
Exclusion Criteria:
Use of additional lens cleaners;
Known sensitivities to any ingredient in either test article;
Systemic or ocular disease or disorder that would negatively affect the conduct or outcome of the study;
History of ocular surgery/trauma within the last 6 months;
Any topical ocular or systemic antibiotics within 7 days of enrollment continuing throughout the study;
Participation in any other ophthalmic drug or device clinical trial within 30 days of enrollent;
Other protocol-defined exclusion criteria may apply.
Facility Information:
Facility Name
Contact Alcon Trial 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
Subjective Comfort With Multipurpose Care Solutions in Soft Contact Lens Wearers
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