Back to resultsMultifocal Contact Lens Use in Previous Contact Lens Wearers With Near Vision Demands (GARM)
Primary Purpose
Presbyopia
Status
Completed
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
lotrafilcon B multifocal contact lens
lotrafilcon B single vision contact lens
Over-reader spectacles
Sponsored by
About this trial
This is an interventional treatment trial for Presbyopia
Eligibility Criteria
Inclusion Criteria:
- has discontinued contact lens wear primarily due to age-related, near vision demands
- requires a reading add of +0.50 to +1.75 D (inclusive) and is correctable to at least 6/9 monocular, distance and near with spectacle correction
- has had an ocular examination in the last 2 years
- Other protocol-defined inclusion/exclusion criteria may apply
Exclusion Criteria:
- has any ocular disease
- has more than a 2.00D prescription difference between eyes
- cannot be fit successfully with the study contact lenses
- has any systemic disease affecting ocular health
- is using any systemic or topical medications that may affect ocular health
- has undergone corneal refractive surgery
- Other protocol-defined inclusion/exclusion criteria may apply
Sites / Locations
- University of Waterloo Centre for Contact Lens Research
Arms of the Study
Arm 1
Arm 2
Arm Type
Other
Other
Arm Label
Multifocal CL / Single vision CL + reading glasses
Single vision CL + reading glasses / Multifocal CL
Arm Description
Lotrafilcon B multifocal contact lenses (CL) worn first, with lotrafilcon B single vision contact lenses (CL) and over-reader spectacles worn second. Both contact lens products worn bilaterally on a daily wear basis; over-reader spectacles worn on an as-needed basis.
Lotrafilcon B single vision contact lenses (CL) and over-reader spectacles worn first, with lotrafilcon B multifocal contact lenses (CL) worn second. Both contact lens products worn bilaterally on a daily wear basis; over-reader spectacles worn on an as-needed basis.
Outcomes
Primary Outcome Measures
Overall Satisfaction With the Lenses
Overall satisfaction with the lenses was interpreted by and assessed by the subject as a single, retrospective measurement of one week's wear time. Overall satisfaction with the lenses was recorded on a questionnaire as a numerical rating on a scale of 1 to 100, with 1 being completely dissatisfied, and 100 being excellent, completely satisfied.
Secondary Outcome Measures
Full Information
NCT ID
NCT00965237
First Posted
August 24, 2009
Last Updated
June 26, 2012
Sponsor
CIBA VISION
Collaborators
University of Waterloo
1. Study Identification
Unique Protocol Identification Number
NCT00965237
Brief Title
Multifocal Contact Lens Use in Previous Contact Lens Wearers With Near Vision Demands
Acronym
GARM
Official Title
P/331/09/C: Multifocal Pilot Study: Refitting Drop Outs (GARM)
Study Type
Interventional
2. Study Status
Record Verification Date
January 2012
Overall Recruitment Status
Completed
Study Start Date
August 2009 (undefined)
Primary Completion Date
December 2009 (Actual)
Study Completion Date
December 2009 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
CIBA VISION
Collaborators
University of Waterloo
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
The purpose of this study is to evaluate the use of a multifocal contact lens in people who previously wore contact lenses but discontinued due to age-related, near vision demands.
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
None (Open Label)
Allocation
Randomized
Enrollment
16 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Multifocal CL / Single vision CL + reading glasses
Arm Type
Other
Arm Description
Lotrafilcon B multifocal contact lenses (CL) worn first, with lotrafilcon B single vision contact lenses (CL) and over-reader spectacles worn second. Both contact lens products worn bilaterally on a daily wear basis; over-reader spectacles worn on an as-needed basis.
Arm Title
Single vision CL + reading glasses / Multifocal CL
Arm Type
Other
Arm Description
Lotrafilcon B single vision contact lenses (CL) and over-reader spectacles worn first, with lotrafilcon B multifocal contact lenses (CL) worn second. Both contact lens products worn bilaterally on a daily wear basis; over-reader spectacles worn on an as-needed basis.
Intervention Type
Device
Intervention Name(s)
lotrafilcon B multifocal contact lens
Intervention Description
Commercially marketed, silicone hydrogel, multifocal contact lens for daily wear use
Intervention Type
Device
Intervention Name(s)
lotrafilcon B single vision contact lens
Intervention Description
Commercially marketed, silicone hydrogel, single vision contact lens for daily wear use
Intervention Type
Other
Intervention Name(s)
Over-reader spectacles
Intervention Description
Reading glasses worn over single vision contact lenses for near vision work on an as-needed basis
Primary Outcome Measure Information:
Title
Overall Satisfaction With the Lenses
Description
Overall satisfaction with the lenses was interpreted by and assessed by the subject as a single, retrospective measurement of one week's wear time. Overall satisfaction with the lenses was recorded on a questionnaire as a numerical rating on a scale of 1 to 100, with 1 being completely dissatisfied, and 100 being excellent, completely satisfied.
Time Frame
1 week of wear
10. Eligibility
Sex
All
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
has discontinued contact lens wear primarily due to age-related, near vision demands
requires a reading add of +0.50 to +1.75 D (inclusive) and is correctable to at least 6/9 monocular, distance and near with spectacle correction
has had an ocular examination in the last 2 years
Other protocol-defined inclusion/exclusion criteria may apply
Exclusion Criteria:
has any ocular disease
has more than a 2.00D prescription difference between eyes
cannot be fit successfully with the study contact lenses
has any systemic disease affecting ocular health
is using any systemic or topical medications that may affect ocular health
has undergone corneal refractive surgery
Other protocol-defined inclusion/exclusion criteria may apply
Facility Information:
Facility Name
University of Waterloo Centre for Contact Lens Research
City
Waterloo
State/Province
Ontario
ZIP/Postal Code
N2L 3G1
Country
Canada
12. IPD Sharing Statement
Learn more about this trial
Multifocal Contact Lens Use in Previous Contact Lens Wearers With Near Vision Demands
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