Comparison of a Multifocal Contact Lens to a Traditional Multifocal Contact Lens

Ciba Vision

Status: Completed

Conditions: Presbyopia

Treatments: Device: Lotrafilcon B multifocal contact lens; Device: Omafilcon A multifocal contact lens

Study type: Interventional

Funder types: Industry

Identifiers

NCT00886119

P-319-C-005 sub 8

Details and patient eligibility

About

The purpose of the trial is to compare the performance of two multifocal contact lens systems/products in established presbyopic subjects.

Enrollment: 48 patients

Sex: All

Ages: 35+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Be at least 35 years of age.
• Best-corrected visual acuity of at least 20/40 in each eye.
• Spectacle add from +1.50D and +2.50D (inclusive).
• Able to be fit in available study sphere powers (Plano to -4.00D).
• Currently wearing soft contact lenses at least 5 days a week.
• Other protocol inclusion / exclusion criteria may apply.

Exclusion criteria

• Requires concurrent ocular medication.
• Eye injury or surgery within twelve weeks immediately prior to enrollment.
• Currently enrolled in an ophthalmic clinical trial.
• Evidence of systemic or ocular abnormality, infection or disease likely to affect successful wear of contact lenses or use of their accessory solutions.
• Previous refractive surgery.
• Astigmatism > 1.00D.
• Currently wearing Proclear Multifocal, Frequency 55 Multifocal or Biomedics EP contact lenses.
• Other protocol inclusion / exclusion criteria may apply.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Single Blind

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48 participants in 2 patient groups

Lotrafilcon B / Omafilcon A

Other group

Description:

Lotrafilcon B, followed by Omafilcon A

Treatment:

Device: Omafilcon A multifocal contact lens

Device: Lotrafilcon B multifocal contact lens

Omafilcon A / Lotrafilcon B

Other group

Description:

Omafilcon A, followed by Lotrafilcon B

Treatment:

Device: Omafilcon A multifocal contact lens

Device: Lotrafilcon B multifocal contact lens