Back to resultsClinical Comparison of Two Silicone Hydrogel Toric Lenses in the US
Primary Purpose
Astigmatism
Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Lotrafilcon B contact lens
Comfilcon A contact lens
Sponsored by
About this trial
This is an interventional treatment trial for Astigmatism
Eligibility Criteria
Inclusion Criteria:
- Have a current spectacle prescription, preferably within 6-9 months.
- Currently wearing toric soft contact lenses in both eyes with at least 1 month experience wearing current brand for daily wear.
- Be correctable to at least 20/40 distance visual acuity in each eye while wearing trial lenses in the parameters available for this trial.
- Have acceptable or optimal fit for each eye at the dispense of each pair of study lenses.
- Other protocol-defined inclusion/exclusion criteria may apply.
Exclusion Criteria:
- Eye injury or surgery within twelve weeks immediately prior to enrollment for this trial.
- Currently enrolled in any Clinical Trial.
- Evidence of systemic or ocular abnormality, infection or disease which is likely to affect successful wear of contact lenses or use of their accessory solutions as determined by the investigator.
- Any use of medications for which contact lens wear could be contraindicated as determined by the investigator.
- Currently wearing soft toric contact lenses as extended wear.
- Currently wearing either of the products to be worn in the study.
- Other protocol-defined inclusion/exclusion criteria may apply.
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Other
Other
Arm Label
Lotrafilcon B / Comfilcon A
Comfilcon A / Lotrafilcon B
Arm Description
Lotrafilcon B silicone hydrogel, toric, soft contact lenses worn for one week, followed by Comfilcon A silicone hydrogel, toric, soft contact lenses worn for one week.
Comfilcon A silicone hydrogel, toric, soft contact lenses worn for one week, followed by Lotrafilcon B silicone hydrogel, toric, soft contact lenses worn for one week.
Outcomes
Primary Outcome Measures
Overall Vision
Overall vision, as interpreted by the subject and reported by the subject on a questionnaire as a single, retrospective evaluation of one week's wear time. Overall vision was 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
NCT01007812
Brief Title
Clinical Comparison of Two Silicone Hydrogel Toric Lenses in the US
Official Title
Clinical Comparison of Two Silicone Hydrogel Toric Lenses in the US
Study Type
Interventional
2. Study Status
Record Verification Date
January 2012
Overall Recruitment Status
Completed
Study Start Date
October 2009 (undefined)
Primary Completion Date
November 2009 (Actual)
Study Completion Date
November 2009 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
CIBA VISION
4. Oversight
5. Study Description
Brief Summary
The purpose of this trial is to compare the performance of two different contact lenses for contact lens wearers with astigmatism.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Astigmatism
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
Participant
Allocation
Randomized
Enrollment
50 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Lotrafilcon B / Comfilcon A
Arm Type
Other
Arm Description
Lotrafilcon B silicone hydrogel, toric, soft contact lenses worn for one week, followed by Comfilcon A silicone hydrogel, toric, soft contact lenses worn for one week.
Arm Title
Comfilcon A / Lotrafilcon B
Arm Type
Other
Arm Description
Comfilcon A silicone hydrogel, toric, soft contact lenses worn for one week, followed by Lotrafilcon B silicone hydrogel, toric, soft contact lenses worn for one week.
Intervention Type
Device
Intervention Name(s)
Lotrafilcon B contact lens
Intervention Description
Silicone hydrogel, toric, soft contact lens
Intervention Type
Device
Intervention Name(s)
Comfilcon A contact lens
Intervention Description
Silicone hydrogel, toric, soft contact lens
Primary Outcome Measure Information:
Title
Overall Vision
Description
Overall vision, as interpreted by the subject and reported by the subject on a questionnaire as a single, retrospective evaluation of one week's wear time. Overall vision was measured on a 10-point scale, with 1 being poor and 10 being excellent.
Time Frame
After 1 week of wear
10. Eligibility
Sex
All
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Have a current spectacle prescription, preferably within 6-9 months.
Currently wearing toric soft contact lenses in both eyes with at least 1 month experience wearing current brand for daily wear.
Be correctable to at least 20/40 distance visual acuity in each eye while wearing trial lenses in the parameters available for this trial.
Have acceptable or optimal fit for each eye at the dispense of each pair of study lenses.
Other protocol-defined inclusion/exclusion criteria may apply.
Exclusion Criteria:
Eye injury or surgery within twelve weeks immediately prior to enrollment for this trial.
Currently enrolled in any Clinical Trial.
Evidence of systemic or ocular abnormality, infection or disease which is likely to affect successful wear of contact lenses or use of their accessory solutions as determined by the investigator.
Any use of medications for which contact lens wear could be contraindicated as determined by the investigator.
Currently wearing soft toric contact lenses as extended wear.
Currently wearing either of the products to be worn in the study.
Other protocol-defined inclusion/exclusion criteria may apply.
12. IPD Sharing Statement
Learn more about this trial
Clinical Comparison of Two Silicone Hydrogel Toric Lenses in the US
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