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

P/331/09/C: Multifocal Pilot Study: Refitting Drop Outs (GARM)

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.

Study Overview

• Status: Completed
• Conditions: Presbyopia
• Intervention / Treatment: Device: lotrafilcon B multifocal contact lens; Device: lotrafilcon B single vision contact lens; Other: Over-reader spectacles

• Study Type: Interventional
• Enrollment (Actual): 16
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Canada
  • Ontario
    • Waterloo, Ontario, Canada, N2L 3G1
      • University of Waterloo Centre for Contact Lens Research

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: ADULT; OLDER_ADULT; CHILD
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: CROSSOVER
• Masking: NONE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: 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
Other: 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Overall Satisfaction With the Lenses	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.	1 week of wear

Collaborators and Investigators

• Sponsor: CIBA VISION
• Collaborators: University of Waterloo

Study record dates

Study Major Dates

• Study Start: August 1, 2009
• Primary Completion (Actual): December 1, 2009
• Study Completion (Actual): December 1, 2009

Study Registration Dates

• First Submitted: August 24, 2009
• First Submitted That Met QC Criteria: August 24, 2009
• First Posted (Estimate): August 25, 2009

Study Record Updates

• Last Update Posted (Estimate): July 10, 2012
• Last Update Submitted That Met QC Criteria: June 26, 2012
• Last Verified: January 1, 2012

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Eye Diseases; Refractive Errors; Presbyopia
• Other Study ID Numbers: P-368-C-101