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OpenTrials
Completed

NCT Number: NCT00965237

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

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.

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Key information

Conditions

Presbyopia Eye Diseases Refractive Errors

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Waterloo Centre for Contact Lens Research

Waterloo, Ontario, N2L 3G1, Canada

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Lotrafilcon B multifocal contact lens

Device

Commercially marketed, silicone hydrogel, multifocal contact lens for daily wear use

lotrafilcon B single vision contact lens

Device

Commercially marketed, silicone hydrogel, single vision contact lens for daily wear use

Over-reader spectacles

Other

Reading glasses worn over single vision contact lenses for near vision work on an as-needed basis

Primary outcomes

  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.

Sponsors and collaborators

Lead sponsor

CIBA VISION

Industry

Collaborators

  • University of Waterloo

Registry information

Official study title

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

Acronym: GARM

Important dates

Study start
2009
Primary completion
2009
Study completion
2009
First posted
Aug 25, 2009
Registry last updated
Jul 10, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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