Multifocal Contact Lens Use in Previous Contact Lens Wearers With Near Vision Demands (GARM)
This study has been completed.
Sponsor:
CIBA VISION
Collaborator:
University of Waterloo
Information provided by (Responsible Party):
Alcon Research ( CIBA VISION )
ClinicalTrials.gov Identifier:
NCT00965237
First received: August 24, 2009
Last updated: June 26, 2012
Last verified: January 2012
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Purpose
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 | Intervention |
|---|---|
|
Presbyopia |
Device: lotrafilcon B multifocal contact lens Device: lotrafilcon B single vision contact lens Other: Over-reader spectacles |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Intervention Model: Crossover Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | P/331/09/C: Multifocal Pilot Study: Refitting Drop Outs (GARM) |
Resource links provided by NLM:
Further study details as provided by Alcon Research:
Primary Outcome Measures:
- Overall Satisfaction With the Lenses [ Time Frame: 1 week of wear ] [ Designated as safety issue: No ]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.
| Enrollment: | 16 |
| Study Start Date: | August 2009 |
| Study Completion Date: | December 2009 |
| Primary Completion Date: | December 2009 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
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.
|
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
|
|
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.
|
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
|
Eligibility| Ages Eligible for Study: | Child, Adult, Senior |
| Genders Eligible for Study: | Both |
| 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
Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study.
To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.
For general information, see Learn About Clinical Studies.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00965237
Please refer to this study by its ClinicalTrials.gov identifier: 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
More Information
| Responsible Party: | CIBA VISION |
| ClinicalTrials.gov Identifier: | NCT00965237 History of Changes |
| Other Study ID Numbers: | P-368-C-101 |
| Study First Received: | August 24, 2009 |
| Results First Received: | January 21, 2011 |
| Last Updated: | June 26, 2012 |
| Health Authority: | Canada: Ethics Review Committee |
Additional relevant MeSH terms:
|
Presbyopia Refractive Errors Eye Diseases |
ClinicalTrials.gov processed this record on September 27, 2016