Clinical Comparison of Two Multifocal Contact Lenses Made of Silicone Hydrogel Materials

Ciba Vision

Status: Completed

Conditions: Myopia; Presbyopia

Treatments: Device: Lotrafilcon B contact lens; Device: Comfilcon A contact lens

Study type: Interventional

Funder types: Industry

Identifiers

NCT01371539

P-319-C-021

Details and patient eligibility

About

The purpose of this study was to compare visual performance measures between two multifocal contact lenses on presbyopic wearers.

Enrollment: 109 patients

Sex: All

Ages: 35+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• At least 35 years of age.
• Spectacle add of +0.50 to +2.50 diopters (inclusive).
• Currently wearing soft contact lenses at least 5 days per week and at least 8 hours per day.
• Able to be fit in both eyes with soft multifocal lenses in available powers.
• Other protocol-defined inclusion criteria may apply.

Exclusion criteria

• Eye injury or surgery within 12 weeks of enrollment in trial.
• Currently enrolled in any clinical trial.
• Astigmatism of 1.00 diopter or more.
• Currently wearing excluded brands of multifocal lenses, as specified by protocol.
• Other protocol-defined exclusion criteria may apply.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Single Blind

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109 participants in 2 patient groups

Lotrafilcon B / Comfilcon A

Other group

Description:

Lotrafilcon B contact lenses worn first, with comfilcon A contact lenses worn second. Both products worn bilaterally on a daily wear basis for one week each.

Treatment:

Device: Comfilcon A contact lens

Device: Lotrafilcon B contact lens

Comfilcon A / Lotrafilcon B

Other group

Description:

Comfilcon A contact lenses worn first, with lotrafilcon B contact lenses worn second. Both products worn bilaterally on a daily wear basis for one week each.

Treatment:

Device: Comfilcon A contact lens

Device: Lotrafilcon B contact lens