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

Ciba Vision

Status: Completed

Conditions: Presbyopia

Treatments: Device: Lotrafilcon B multifocal contact lens

Study type: Interventional

Funder types: Industry

Identifiers

NCT01268501

P-319-C-019

Details and patient eligibility

About

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

Enrollment: 103 patients

Sex: All

Ages: 40 to 48 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

---

103 participants in 1 patient group

Lotrafilcon B multifocal

Experimental group

Description:

Lotrafilcon B multifocal contact lenses worn bilaterally for 3 weeks on a daily wear basis

Treatment:

Device: Lotrafilcon B multifocal contact lens