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Multifocal Contact Lens Use in Previous Contact Lens Wearers With Near Vision Demands (GARM)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00965237
Recruitment Status : Completed
First Posted : August 25, 2009
Results First Posted : March 14, 2011
Last Update Posted : July 10, 2012
Sponsor:
Collaborator:
Information provided by (Responsible Party):

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.

Condition or disease Intervention/treatment
Presbyopia Device: lotrafilcon B multifocal contact lens Device: lotrafilcon B single vision contact lens Other: Over-reader spectacles

Study Design

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
Primary Completion Date : December 2009
Study Completion Date : December 2009

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Eye Wear
U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
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


Outcome Measures

Primary Outcome Measures :
  1. 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.


Eligibility Criteria

Information from the National Library of Medicine

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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
Contacts and Locations

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
More Information

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:
Presbyopia
Refractive Errors
Eye Diseases