Clinical Evaluation of Two New Silicone Hydrogel Multifocal Products

Ciba Vision

Status: Completed

Conditions: Presbyopia

Treatments: Device: Lotrafilcon B; Device: Senofilcon A

Study type: Interventional

Funder types: Industry

Identifiers

NCT00909792

P-319-C-013

Details and patient eligibility

About

The objective of this trial is compare the visual performance, ratings, and preference of two multifocal, soft contact lenses.

Enrollment: 259 patients

Sex: All

Ages: 35+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Be at least 35 years of age
• Best-corrected distance visual acuity of at least 20/40 in each eye.
• Spectacle add between +0.75D and +1.50D (inclusive).
• Able to be fit in available study sphere powers (-1.00 to -5.00D)
• Currently wearing soft contact lenses at least 5 days a week.
• Other protocol inclusion/exclusion criteria may apply.

Exclusion criteria

• 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.
• Any use of medications for which contact lens wear could be contraindicated as determined by the investigator.
• Astigmatism ≥ 1.00D.
• Currently wearing either of the study products.
• 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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259 participants in 2 patient groups

Lotrafilcon B / Senofilcon A

Other group

Description:

Lotrafilcon B, followed by Senofilcon A

Treatment:

Device: Senofilcon A

Device: Lotrafilcon B

Senofilcon A / Lotrafilcon B

Other group

Description:

Senofilcon A, followed by Lotrafilcon B

Treatment:

Device: Senofilcon A

Device: Lotrafilcon B