Clinical Evaluation of a Silicone Hydrogel Lens

Ciba Vision

Status: Completed

Conditions: Myopia

Treatments: Device: lotrafilcon A contact lens

Study type: Interventional

Funder types: Industry

Identifiers

NCT01016132

P-019-C-055

Details and patient eligibility

About

The purpose of this study is to assess the performance of an investigational contact lens among contact lens wearers.

Enrollment: 152 patients

Sex: All

Volunteers: No Healthy Volunteers

Inclusion criteria

• Currently wearing lotrafilcon A lenses in both eyes for a minimum of 5 days per week, 8 hours per day, for 3 months.
• Removes contact lenses daily or sleeps overnight in contact lenses (up to 30 consecutive nights) as prescribed by regular eye care practitioner.
• Able to achieve distance visual acuity of at least 20/40 in each eye with study lenses.
• Other protocol inclusion/exclusion criteria may apply.

Exclusion criteria

• Eye injury or surgery within 12 months prior to enrollment.
• Currently enrolled in any clinical trial.
• History of corneal refractive surgery.
• Other protocol inclusion/exclusion criteria may apply.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: Double Blind