Comparative In-Vivo Wetting Characteristics of Silicone Hydrogel Materials With Selected Lens Care Systems

Alcon

Status

Completed

Conditions

Myopia

Refractive Error

Astigmatism

Treatments

Device: Lotrafilcon B contact lenses

Device: ReNu® Multiplus®

Device: OPTI-FREE® PUREMOIST® MPDS

Device: Balafilcon A contact lenses

Device: BIOTRUE®

Device: Senofilcon A contact lenses

Study type

Interventional

Funder types

Industry

Identifiers

NCT01699750

M-12-043 / ID11-59

Details and patient eligibility

About

The purpose of this study is to evaluate the lipid uptake, wetting characteristics, and visual performance of AIR OPTIX® AQUA and ACUVUE® OASYS® with HYDRACLEAR® contact lenses when used in conjunction with two contact lens care systems.

Full description

This study will be divided into two phases. In the Pre-Investigational Phase (Phase 1), participants will wear PureVision contact lenses for 30 days and use ReNu® Multiplus® for contact lens care. Eligible participants will continue into the Investigational Phase (Phase 2) and be randomly assigned to wear AIR OPTIX® AQUA contact lenses or ACUVUE® OASYS® with HYDRACLEAR® contact lenses for a total of two months. For contact lens care, participants will use OPTI-FREE® PUREMOIST® MPDS and BIOTRUE® for 30 days each.

Enrollment

109 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

Read and understand the Participant Information Sheet;
Read, sign, and date the Informed Consent;
Be a current silicone hydrogel contact lens wearer using the contact lenses under a frequent replacement (bi-weekly or monthly) daily wear modality;
Be classified as symptomatic and a depositor at the end of the replacement period according to protocol-specified criteria;
Agree to wear study contact lenses as directed for the duration of the study and maintain the appointment schedule;
Best corrected visual acuity of 6/9 or better in each eye;
Normal eyes with the exception of the need for visual correction;
Other protocol-defined inclusion criteria may apply.

Exclusion criteria

Known sensitivity or intolerance to any of the contact lenses or contact lens care products to be used;
Monocular vision (only one eye with functional vision or only one eye fitted with contact lenses);
Use of systemic medication which might interfere with contact lens wear or produce dry eye side effects;
Systemic disease which might interfere with contact lens wear or produce dry eye side effects;
Systemic or ocular allergies which might interfere with contact lens wear;
Ocular disease which might interfere with contact lens wear;
Active ocular infection;
Use of any concomitant topical ocular medications during the study period;
Previous ocular surgery;
Pregnant, planning to become pregnant, or lactating at the time of enrollment;
Participation in an investigational drug or device study within 30 days of entering this study;
Other protocol-defined exclusion criteria may apply.