Back to resultsClinical Comparison of Two Multifocal Contact Lenses Made of Silicone Hydrogel Materials
Primary Purpose
Myopia, Presbyopia
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 Myopia focused on measuring Myopia, Presbyopia
Eligibility Criteria
Inclusion Criteria:
- At least 35 years of age.
- Spectacle add of +0.50 to +2.50 diopters (inclusive).
- Currently wearing soft contact lenses at least 5 days per week and at least 8 hours per day.
- Able to be fit in both eyes with soft multifocal lenses in available powers.
- Other protocol-defined inclusion criteria may apply.
Exclusion Criteria:
- Eye injury or surgery within 12 weeks of enrollment in trial.
- Currently enrolled in any clinical trial.
- Astigmatism of 1.00 diopter or more.
- Currently wearing excluded brands of multifocal lenses, as specified by protocol.
- Other protocol-defined 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 contact lenses worn first, with comfilcon A contact lenses worn second. Both products worn bilaterally on a daily wear basis for one week each.
Comfilcon A contact lenses worn first, with lotrafilcon B contact lenses worn second. Both products worn bilaterally on a daily wear basis for one week each.
Outcomes
Primary Outcome Measures
Corrected Distance Binocular Visual Measurement in Normal Illumination Reported as Binocular Distance Visual Acuity
The participant read a Snellen chart at a 20-foot equivalent distance with both eyes together while wearing study lenses. The Snellen acuity was converted into logMAR units (logarithm of the minimum angle of resolution). A 20/20 Snellen acuity equated to a logMAR acuity of 0.0 and was considered normal distance eyesight. A positive logMAR value indicated poorer vision, and a negative value denoted better visual acuity.
Corrected Near Binocular Visual Measurement in Normal Illumination Reported as Binocular Near Visual Acuity
The participant read a Snellen chart at 40 centimeters with both eyes together while wearing study lenses. The Snellen acuity was converted into logMAR units (logarithm of the minimum angle of resolution). A 20/20 Snellen acuity equated to a logMAR acuity of 0.0 and was considered normal near eyesight. A positive logMAR value indicated poorer vision, and a negative value denoted better visual acuity.
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01371539
Brief Title
Clinical Comparison of Two Multifocal Contact Lenses Made of Silicone Hydrogel Materials
Official Title
Clinical Comparison of Two Multifocal Contact Lenses Made of Silicone Hydrogel Materials
Study Type
Interventional
2. Study Status
Record Verification Date
June 2012
Overall Recruitment Status
Completed
Study Start Date
June 2011 (undefined)
Primary Completion Date
August 2011 (Actual)
Study Completion Date
August 2011 (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 was to compare visual performance measures between two multifocal contact lenses on presbyopic wearers.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Myopia, Presbyopia
Keywords
Myopia, Presbyopia
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
Participant
Allocation
Randomized
Enrollment
109 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Lotrafilcon B / Comfilcon A
Arm Type
Other
Arm Description
Lotrafilcon B contact lenses worn first, with comfilcon A contact lenses worn second. Both products worn bilaterally on a daily wear basis for one week each.
Arm Title
Comfilcon A / Lotrafilcon B
Arm Type
Other
Arm Description
Comfilcon A contact lenses worn first, with lotrafilcon B contact lenses worn second. Both products worn bilaterally on a daily wear basis for one week each.
Intervention Type
Device
Intervention Name(s)
Lotrafilcon B contact lens
Other Intervention Name(s)
AIR OPTIX AQUA MULTIFOCAL
Intervention Description
Commercially marketed, silicone hydrogel, multifocal contact lens for daily wear use.
Intervention Type
Device
Intervention Name(s)
Comfilcon A contact lens
Other Intervention Name(s)
Biofinity Multifocal
Intervention Description
Commercially marketed (France), silicone hydrogel, multifocal contact lens for daily wear use.
Primary Outcome Measure Information:
Title
Corrected Distance Binocular Visual Measurement in Normal Illumination Reported as Binocular Distance Visual Acuity
Description
The participant read a Snellen chart at a 20-foot equivalent distance with both eyes together while wearing study lenses. The Snellen acuity was converted into logMAR units (logarithm of the minimum angle of resolution). A 20/20 Snellen acuity equated to a logMAR acuity of 0.0 and was considered normal distance eyesight. A positive logMAR value indicated poorer vision, and a negative value denoted better visual acuity.
Time Frame
1 week
Title
Corrected Near Binocular Visual Measurement in Normal Illumination Reported as Binocular Near Visual Acuity
Description
The participant read a Snellen chart at 40 centimeters with both eyes together while wearing study lenses. The Snellen acuity was converted into logMAR units (logarithm of the minimum angle of resolution). A 20/20 Snellen acuity equated to a logMAR acuity of 0.0 and was considered normal near eyesight. A positive logMAR value indicated poorer vision, and a negative value denoted better visual acuity.
Time Frame
1 week
10. Eligibility
Sex
All
Minimum Age & Unit of Time
35 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
At least 35 years of age.
Spectacle add of +0.50 to +2.50 diopters (inclusive).
Currently wearing soft contact lenses at least 5 days per week and at least 8 hours per day.
Able to be fit in both eyes with soft multifocal lenses in available powers.
Other protocol-defined inclusion criteria may apply.
Exclusion Criteria:
Eye injury or surgery within 12 weeks of enrollment in trial.
Currently enrolled in any clinical trial.
Astigmatism of 1.00 diopter or more.
Currently wearing excluded brands of multifocal lenses, as specified by protocol.
Other protocol-defined exclusion criteria may apply.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Stacie Cummings, O.D.
Organizational Affiliation
Alcon Research
Official's Role
Study Director
12. IPD Sharing Statement
Learn more about this trial
Clinical Comparison of Two Multifocal Contact Lenses Made of Silicone Hydrogel Materials
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