Back to resultsClinical Assessment of a Multifocal Contact Lens for People Who Use Reading Glasses Only
Primary Purpose
Presbyopia
Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Lotrafilcon B multifocal contact lens
Sponsored by
About this trial
This is an interventional treatment trial for Presbyopia
Eligibility Criteria
Inclusion Criteria:
- Is between 40 and 48 years of age (inclusive).
- Has read and signed the Informed Consent.
- Is willing and able to follow instructions and maintain the appointment schedule.
- Wears reading spectacles for close work.
- Other protocol-defined inclusion/exclusion criteria may apply.
Exclusion Criteria:
- Eye injury or surgery within twelve weeks of enrollment.
- Evidence of systemic or ocular abnormality, infection, or disease likely to affect successful wear of contact lenses or use of accessory solutions.
- Currently enrolled in a clinical trial.
- Has worn contact lenses previously.
- Other protocol-defined inclusion/exclusion criteria may apply.
Sites / Locations
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Lotrafilcon B multifocal
Arm Description
Lotrafilcon B multifocal contact lenses worn bilaterally for 3 weeks on a daily wear basis
Outcomes
Primary Outcome Measures
Overall Convenience With Contact Lenses
Overall convenience with contact lenses, as interpreted by the participant and reported on a questionnaire as a single, retrospective evaluation of 3 weeks of wear time. Overall convenience is measured on a 4-point scale: 1=very satisfied; 2=satisfied; 3=dissatisfied; 4=very dissatisfied. Results were reported as a percentage of participants who responded, "very satisfied" or "satisfied."
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01268501
Brief Title
Clinical Assessment of a Multifocal Contact Lens for People Who Use Reading Glasses Only
Official Title
Clinical Assessment of a New Multifocal Contact Lens With Emmetropic Presbyopes
Study Type
Interventional
2. Study Status
Record Verification Date
February 2012
Overall Recruitment Status
Completed
Study Start Date
December 2010 (undefined)
Primary Completion Date
February 2011 (Actual)
Study Completion Date
February 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 trial is to evaluate the use of multifocal contact lenses in people who use reading glasses only.
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
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
103 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Lotrafilcon B multifocal
Arm Type
Experimental
Arm Description
Lotrafilcon B multifocal contact lenses worn bilaterally for 3 weeks on a daily wear basis
Intervention Type
Device
Intervention Name(s)
Lotrafilcon B multifocal contact lens
Other Intervention Name(s)
AIR OPTIX® AQUA MULTIFOCAL
Intervention Description
Commercially marketed, silicone hydrogel, multifocal, soft contact lenses FDA-approved for up to 4 weeks recommended replacement schedule and up to 6 nights of extended (overnight) wear.
Primary Outcome Measure Information:
Title
Overall Convenience With Contact Lenses
Description
Overall convenience with contact lenses, as interpreted by the participant and reported on a questionnaire as a single, retrospective evaluation of 3 weeks of wear time. Overall convenience is measured on a 4-point scale: 1=very satisfied; 2=satisfied; 3=dissatisfied; 4=very dissatisfied. Results were reported as a percentage of participants who responded, "very satisfied" or "satisfied."
Time Frame
3 weeks of wear
10. Eligibility
Sex
All
Minimum Age & Unit of Time
40 Years
Maximum Age & Unit of Time
48 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Is between 40 and 48 years of age (inclusive).
Has read and signed the Informed Consent.
Is willing and able to follow instructions and maintain the appointment schedule.
Wears reading spectacles for close work.
Other protocol-defined inclusion/exclusion criteria may apply.
Exclusion Criteria:
Eye injury or surgery within twelve weeks of enrollment.
Evidence of systemic or ocular abnormality, infection, or disease likely to affect successful wear of contact lenses or use of accessory solutions.
Currently enrolled in a clinical trial.
Has worn contact lenses previously.
Other protocol-defined inclusion/exclusion criteria may apply.
12. IPD Sharing Statement
Learn more about this trial
Clinical Assessment of a Multifocal Contact Lens for People Who Use Reading Glasses Only
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