Evaluation of Two Silicone Hydrogel Lenses Over a One Month Period

Ciba Vision

Status: Completed

Conditions: Myopia

Treatments: Device: Lotrafilcon A contact lens; Device: Comfilcon A contact lens

Study type: Interventional

Funder types: Industry

Identifiers

NCT00810511

P-335-C-007

Details and patient eligibility

About

The purpose of this trial is to compare two different contact lenses during 4 weeks of wear.

Enrollment: 213 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Current soft contact lens wearer who wear their habitual lenses for no less than 10 hours a day, 5 days a week
• Have a need for correction in both eyes and be correctable to at least 20/40 distance vision in each eye while wearing trial lenses
• Replace lenses on a weekly or longer schedule
• Other protocol inclusion/exclusion criteria may apply

Exclusion criteria

• Requires concurrent ocular medication
• Eye injury or surgery within twelve weeks immediately prior to enrollment
• Evidence of systemic or ocular abnormality, infection, or disease likely to affect successful wear of contact lenses or use of their accessory solutions
• Current soft toric lens wearers
• Those who dispose of their soft lenses on a daily basis
• Current NIGHT & DAY® or Biofinity® lens wearers
• Other protocol-defined inclusion/exclusion criteria may apply

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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213 participants in 2 patient groups

Lotrafilcon A

Experimental group

Description:

Investigational, spherical, silicone hydrogel contact lenses

Treatment:

Device: Lotrafilcon A contact lens

Comfilcon A

Active Comparator group

Description:

Commercially marketed, spherical, silicone hydrogel contact lenses

Treatment:

Device: Comfilcon A contact lens