Back to resultsNon-dispense Comfort Comparison of Two Silicone Hydrogel Lenses
Primary Purpose
Myopia
Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Lotrafilcon A contact lens
Senofilcon A contact lens
Sponsored by
About this trial
This is an interventional treatment trial for Myopia
Eligibility Criteria
Inclusion Criteria:
- Currently wearing soft contact lenses
- Replaces lenses on a weekly or longer schedule
- Other protocol-defined inclusion/exclusion criteria may apply
Exclusion Criteria:
- Requires concurrent ocular medication
- Eye injury or surgery within twelve weeks immediately prior to enrollment
- Currently wearing soft toric lens wearers
- Those who dispose of their soft lenses on a daily basis
- Other protocol-defined inclusion/exclusion criteria may apply
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Other
Other
Arm Label
Senofilcon A / Lotrafilcon A
Lotrafilcon A / Senofilcon A
Arm Description
Senofilcon A, followed by Lotrafilcon A
Lotrafilcon A, followed by Senofilcon A
Outcomes
Primary Outcome Measures
Comfort After Insertion
Evaluated by the subject and measured on a 10-point scale, with 1 being poor and 10 being excellent.
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00808834
Brief Title
Non-dispense Comfort Comparison of Two Silicone Hydrogel Lenses
Official Title
Non-dispense Comfort Comparison of Two Silicone Hydrogel Lenses
Study Type
Interventional
2. Study Status
Record Verification Date
January 2012
Overall Recruitment Status
Completed
Study Start Date
November 2008 (undefined)
Primary Completion Date
December 2008 (Actual)
Study Completion Date
December 2008 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
CIBA VISION
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
The purpose of this study is to compare subjective responses to two contact lenses after 15 minutes of wear.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Myopia
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
196 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Senofilcon A / Lotrafilcon A
Arm Type
Other
Arm Description
Senofilcon A, followed by Lotrafilcon A
Arm Title
Lotrafilcon A / Senofilcon A
Arm Type
Other
Arm Description
Lotrafilcon A, followed by Senofilcon A
Intervention Type
Device
Intervention Name(s)
Lotrafilcon A contact lens
Intervention Description
Investigational, silicone hydrogel, spherical, soft contact lens
Intervention Type
Device
Intervention Name(s)
Senofilcon A contact lens
Intervention Description
Commercially marketed, silicone hydrogel, spherical, soft contact lens
Primary Outcome Measure Information:
Title
Comfort After Insertion
Description
Evaluated by the subject and measured on a 10-point scale, with 1 being poor and 10 being excellent.
Time Frame
30-60 seconds after initial insertion
10. Eligibility
Sex
All
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Currently wearing soft contact lenses
Replaces lenses on a weekly or longer schedule
Other protocol-defined inclusion/exclusion criteria may apply
Exclusion Criteria:
Requires concurrent ocular medication
Eye injury or surgery within twelve weeks immediately prior to enrollment
Currently wearing soft toric lens wearers
Those who dispose of their soft lenses on a daily basis
Other protocol-defined inclusion/exclusion criteria may apply
12. IPD Sharing Statement
Learn more about this trial
Non-dispense Comfort Comparison of Two Silicone Hydrogel Lenses
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