Back to resultsComparison of a Multifocal Contact Lens to a Traditional Multifocal Contact Lens
Primary Purpose
Presbyopia
Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Lotrafilcon B multifocal contact lens
Omafilcon A multifocal contact lens
Sponsored by
About this trial
This is an interventional treatment trial for Presbyopia
Eligibility Criteria
Inclusion Criteria:
- Be at least 35 years of age.
- Best-corrected visual acuity of at least 20/40 in each eye.
- Spectacle add from +1.50D and +2.50D (inclusive).
- Able to be fit in available study sphere powers (Plano to -4.00D).
- Currently wearing soft contact lenses at least 5 days a week.
- Other protocol inclusion / exclusion criteria may apply.
Exclusion Criteria:
- Requires concurrent ocular medication.
- Eye injury or surgery within twelve weeks immediately prior to enrollment.
- Currently enrolled in an ophthalmic clinical trial.
- Evidence of systemic or ocular abnormality, infection or disease likely to affect successful wear of contact lenses or use of their accessory solutions.
- Previous refractive surgery.
- Astigmatism > 1.00D.
- Currently wearing Proclear Multifocal, Frequency 55 Multifocal or Biomedics EP contact lenses.
- Other protocol inclusion / exclusion criteria may apply.
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Other
Other
Arm Label
Lotrafilcon B / Omafilcon A
Omafilcon A / Lotrafilcon B
Arm Description
Lotrafilcon B, followed by Omafilcon A
Omafilcon A, followed by Lotrafilcon B
Outcomes
Primary Outcome Measures
Corrected Distance Binocular Visual Measurement in Normal Illumination Reported as Binocular Distance Visual Acuity
Tested while reading charts distant to the subject with both eyes together in normal lighting. This outcome is measured in logMAR units (logarithm of the minimum angle of resolution). A logMAR acuity of 0.0 equates to 20/20 Snellen acuity and is considered normal. Positive logMAR values indicate poorer vision and negative values denote better visual acuity.
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00886119
Brief Title
Comparison of a Multifocal Contact Lens to a Traditional Multifocal Contact Lens
Official Title
Lotrafilcon B Multifocal Evaluations - Comparison to a Traditional Multifocal in Higher Spectacle Adds
Study Type
Interventional
2. Study Status
Record Verification Date
January 2012
Overall Recruitment Status
Completed
Study Start Date
April 2009 (undefined)
Primary Completion Date
May 2009 (Actual)
Study Completion Date
May 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 the trial is to compare the performance of two multifocal contact lens systems/products in established presbyopic subjects.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Presbyopia
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
Participant
Allocation
Randomized
Enrollment
48 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Lotrafilcon B / Omafilcon A
Arm Type
Other
Arm Description
Lotrafilcon B, followed by Omafilcon A
Arm Title
Omafilcon A / Lotrafilcon B
Arm Type
Other
Arm Description
Omafilcon A, followed by Lotrafilcon B
Intervention Type
Device
Intervention Name(s)
Lotrafilcon B multifocal contact lens
Intervention Description
Silicone hydrogel, soft, multifocal contact lens for daily wear use
Intervention Type
Device
Intervention Name(s)
Omafilcon A multifocal contact lens
Intervention Description
Hydrogel, soft, 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
Tested while reading charts distant to the subject with both eyes together in normal lighting. This outcome is measured in logMAR units (logarithm of the minimum angle of resolution). A logMAR acuity of 0.0 equates to 20/20 Snellen acuity and is considered normal. Positive logMAR values indicate poorer vision and negative values denote better visual acuity.
Time Frame
After 1 week of wear
10. Eligibility
Sex
All
Minimum Age & Unit of Time
35 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Be at least 35 years of age.
Best-corrected visual acuity of at least 20/40 in each eye.
Spectacle add from +1.50D and +2.50D (inclusive).
Able to be fit in available study sphere powers (Plano to -4.00D).
Currently wearing soft contact lenses at least 5 days a week.
Other protocol inclusion / exclusion criteria may apply.
Exclusion Criteria:
Requires concurrent ocular medication.
Eye injury or surgery within twelve weeks immediately prior to enrollment.
Currently enrolled in an ophthalmic clinical trial.
Evidence of systemic or ocular abnormality, infection or disease likely to affect successful wear of contact lenses or use of their accessory solutions.
Previous refractive surgery.
Astigmatism > 1.00D.
Currently wearing Proclear Multifocal, Frequency 55 Multifocal or Biomedics EP contact lenses.
Other protocol inclusion / exclusion criteria may apply.
12. IPD Sharing Statement
Learn more about this trial
Comparison of a Multifocal Contact Lens to a Traditional Multifocal Contact Lens
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