Multifocal Contact Lens Use in Previous Contact Lens Wearers With Near Vision Demands

Presbyopia Clinical Trial

— GARM  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00965237
• Other study ID #: P-368-C-101
• Status: Completed
• Phase: N/A
• First received: August 24, 2009
• Last updated: June 26, 2012
• Start date: August 2009
• Est. completion date: December 2009

Study information

• Verified date: January 2012
• Source: Alcon Research
• Contact: n/a
• Is FDA regulated: No
• Health authority: Canada: Ethics Review Committee
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 16
• Est. completion date: December 2009
• Est. primary completion date: December 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A and older

Eligibility

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 Design

Allocation: Randomized, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Presbyopia

Intervention

Device:
• lotrafilcon B multifocal contact lens
Commercially marketed, silicone hydrogel, multifocal contact lens for daily wear use
• 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

Locations

Country	Name	City	State
Canada	University of Waterloo Centre for Contact Lens Research	Waterloo	Ontario

Sponsors (2)

Lead Sponsor	Collaborator
CIBA VISION	University of Waterloo

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No