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

This study has been completed.
Sponsor:
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
History of Changes
  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:

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

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

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
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

No publications provided

Responsible Party: Alcon Research ( 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 May 16, 2013