Comparison of Two Multifocal Contact Lenses Worn on a Daily Disposable Basis

Ciba Vision

Status: Completed

Conditions: Myopia; Presbyopia

Treatments: Device: Nelfilcon A multifocal contact lens, investigational; Device: Nelfilcon A multifocal contact lens, commercial

Study type: Interventional

Funder types: Industry

Identifiers

NCT01254760

P-416-C-001 Sub 04

Details and patient eligibility

About

The purpose of this trial is to evaluate and compare the clinical performance of two multifocal contact lenses.

Enrollment: 79 patients

Sex: All

Ages: 41 to 68 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Age 41 to 68 (inclusive).
• Spectacle add between +0.75 and +2.75D (inclusive).
• Habitual spectacle prescription ≤ 1.00DC (cyl).
• Other protocol-defined inclusion criteria may apply.

Exclusion criteria

• Eye injury or surgery within twelve weeks of enrollment.
• Pre-existing ocular irritation that would preclude contact lens fitting.
• Currently enrolled in a clinical trial.
• Prior refractive surgery.
• 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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79 participants in 2 patient groups

Investigational multifocal / Commercial multifocal

Other group

Description:

Investigational multifocal contact lenses worn first, with commercial multifocal contact lenses worn second. Each product worn bilaterally on a daily wear, daily disposable basis for 5 days.

Treatment:

Device: Nelfilcon A multifocal contact lens, commercial

Device: Nelfilcon A multifocal contact lens, investigational

Commercial multifocal / Investigational multifocal

Other group

Description:

Commercial multifocal contact lenses worn first, with investigational multifocal contact lenses worn second. Each product worn bilaterally on a daily wear, daily disposable basis for 5 days.

Treatment:

Device: Nelfilcon A multifocal contact lens, commercial

Device: Nelfilcon A multifocal contact lens, investigational