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

• 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: CIBA VISION
• Collaborator: University of Waterloo
• Information provided by (Responsible Party): Alcon Research ( CIBA VISION )

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	Phase
Presbyopia	Device: lotrafilcon B multifocal contact lens; Device: lotrafilcon B single vision contact lens; Other: Over-reader spectacles	Not Applicable

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
• Actual Primary Completion Date: December 2009
• Actual Study Completion Date: December 2009

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

• Ages Eligible for Study: Child, Adult, Older Adult
• 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

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
• 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