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

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

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

ClinicalTrials.gov processed this record on March 01, 2015

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