Multifocal Contact Lens Use in Previous Contact Lens Wearers With Near Vision Demands (GARM)

Ciba Vision

Status: Completed

Conditions: Presbyopia

Treatments: Device: lotrafilcon B multifocal contact lens; Device: lotrafilcon B single vision contact lens; Other: Over-reader spectacles

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT00965237

P-368-C-101

Details and patient eligibility

About

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.

Enrollment: 16 patients

Sex: All

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

---

16 participants in 2 patient groups

Multifocal CL / Single vision CL + reading glasses

Other group

Description:

Lotrafilcon B multifocal contact lenses (CL) worn first, with lotrafilcon B single vision contact lenses (CL) and over-reader spectacles worn second. Both contact lens products worn bilaterally on a daily wear basis; over-reader spectacles worn on an as-needed basis.

Treatment:

Device: lotrafilcon B multifocal contact lens

Device: lotrafilcon B single vision contact lens

Other: Over-reader spectacles

Single vision CL + reading glasses / Multifocal CL

Other group

Description:

Lotrafilcon B single vision contact lenses (CL) and over-reader spectacles worn first, with lotrafilcon B multifocal contact lenses (CL) worn second. Both contact lens products worn bilaterally on a daily wear basis; over-reader spectacles worn on an as-needed basis.

Treatment:

Device: lotrafilcon B multifocal contact lens

Device: lotrafilcon B single vision contact lens

Other: Over-reader spectacles