Multifocal Contact Lens Use in Previous Contact Lens Wearers With Near Vision Demands (GARM)
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| ClinicalTrials.gov Identifier: NCT00965237 |
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Recruitment Status
:
Completed
First Posted
: August 25, 2009
Results First Posted
: March 14, 2011
Last Update Posted
: July 10, 2012
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Sponsor:
CIBA VISION
Collaborator:
University of Waterloo
Information provided by (Responsible Party):
Alcon Research ( CIBA VISION )
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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.
| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Presbyopia | Device: lotrafilcon B multifocal contact lens Device: lotrafilcon B single vision contact lens Other: Over-reader spectacles | Not Applicable |
| Study Type : | Interventional (Clinical Trial) |
| Actual Enrollment : | 16 participants |
| Allocation: | Randomized |
| Intervention Model: | Crossover Assignment |
| Masking: | None (Open Label) |
| Primary Purpose: | Treatment |
| Official Title: | P/331/09/C: Multifocal Pilot Study: Refitting Drop Outs (GARM) |
| Study Start Date : | August 2009 |
| Actual Primary Completion Date : | December 2009 |
| Actual Study Completion Date : | December 2009 |
Resource links provided by the National Library of Medicine
MedlinePlus related topics:
Eye Wear
U.S. FDA Resources
| Arm | Intervention/treatment |
|---|---|
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Multifocal CL / Single vision CL + reading glasses
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.
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Device: lotrafilcon B multifocal contact lens
Commercially marketed, silicone hydrogel, multifocal contact lens for daily wear use
Device: lotrafilcon B single vision contact lens
Commercially marketed, silicone hydrogel, single vision contact lens for daily wear use
Other: Over-reader spectacles
Reading glasses worn over single vision contact lenses for near vision work on an as-needed basis
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Single vision CL + reading glasses / Multifocal CL
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.
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Device: lotrafilcon B multifocal contact lens
Commercially marketed, silicone hydrogel, multifocal contact lens for daily wear use
Device: lotrafilcon B single vision contact lens
Commercially marketed, silicone hydrogel, single vision contact lens for daily wear use
Other: Over-reader spectacles
Reading glasses worn over single vision contact lenses for near vision work on an as-needed basis
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Primary Outcome Measures
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- Overall Satisfaction With the Lenses [ Time Frame: 1 week of wear ]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.
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| Ages Eligible for Study: | Child, Adult, Senior |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
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
Information from the National Library of Medicine
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00965237
Locations
| Canada, Ontario | |
| University of Waterloo Centre for Contact Lens Research | |
| Waterloo, Ontario, Canada, N2L 3G1 | |
Sponsors and Collaborators
CIBA VISION
University of Waterloo
| Responsible Party: | CIBA VISION |
| ClinicalTrials.gov Identifier: | NCT00965237 History of Changes |
| Other Study ID Numbers: |
P-368-C-101 |
| First Posted: | August 25, 2009 Key Record Dates |
| Results First Posted: | March 14, 2011 |
| Last Update Posted: | July 10, 2012 |
| Last Verified: | January 2012 |
Additional relevant MeSH terms:
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Presbyopia Refractive Errors Eye Diseases |