Clinical Assessment of a Multifocal Contact Lens for People Who Use Reading Glasses Only

The purpose of this trial is to evaluate the use of multifocal contact lenses in people who use reading glasses only.

Completed

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Key information

Conditions

Presbyopia Eye Diseases Refractive Errors

Age range

40 year–48 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

Is between 40 and 48 years of age (inclusive).
Has read and signed the Informed Consent.
Is willing and able to follow instructions and maintain the appointment schedule.
Wears reading spectacles for close work.
Other protocol-defined inclusion/exclusion criteria may apply.

Exclusion criteria

Eye injury or surgery within twelve weeks of enrollment.
Evidence of systemic or ocular abnormality, infection, or disease likely to affect successful wear of contact lenses or use of accessory solutions.
Currently enrolled in a clinical trial.
Has worn contact lenses previously.
Other protocol-defined inclusion/exclusion criteria may apply.

Treatment and study plan

Lotrafilcon B multifocal contact lens

Device

Commercially marketed, silicone hydrogel, multifocal, soft contact lenses FDA-approved for up to 4 weeks recommended replacement schedule and up to 6 nights of extended (overnight) wear.

Other names: AIR OPTIX® AQUA MULTIFOCAL

Primary outcomes

Overall Convenience With Contact Lenses

Time frame: 3 weeks of wear

Overall convenience with contact lenses, as interpreted by the participant and reported on a questionnaire as a single, retrospective evaluation of 3 weeks of wear time. Overall convenience is measured on a 4-point scale: 1=very satisfied; 2=satisfied; 3=dissatisfied; 4=very dissatisfied. Results were reported as a percentage of participants who responded, "very satisfied" or "satisfied."

Sponsors and collaborators

Lead sponsor

CIBA VISION

Industry

Registry information

Official study title

Clinical Assessment of a New Multifocal Contact Lens With Emmetropic Presbyopes

Important dates

Study start: 2010
Primary completion: 2011
Study completion: 2011
First posted: Dec 31, 2010
Registry last updated: Jun 29, 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.

Published trials that share one or more normalized conditions with this study.

Completed