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

Alcon Research1 site in 1 country109 target enrollmentStarted: December 1, 2012Last updated: December 8, 2014

Conditions

Interventions

Trial Snapshot

Phase: Not Applicable
Status: Completed
Sponsor: Alcon Research
Enrollment: 109
Locations: 1
Primary Endpoint: Mean Ex-Vivo Total Lipid Uptake Per Lens

Study Overview Study Design Eligibility Criteria Arms & Interventions Outcomes Investigators Sites Records & Identifiers Similar Trials

Study Overview

Brief Summary

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.

Detailed 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.

Study Design

Study Type: Interventional
Allocation: Randomized
Intervention Model: Parallel
Masking: Single (Participant)

Eligibility Criteria

Ages: 18 Years to — (Adult, Older Adult)
Sex: All
Accepts Healthy Volunteers: No

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.

Arms & Interventions

Air Optix Aqua

Experimental

Lotrafilcon B contact lenses with OFPM and BIOTRUE for 30 days each

Intervention: Balafilcon A contact lenses (Device)

Air Optix Aqua

Experimental

Lotrafilcon B contact lenses with OFPM and BIOTRUE for 30 days each

Intervention: Lotrafilcon B contact lenses (Device)

Air Optix Aqua

Experimental

Lotrafilcon B contact lenses with OFPM and BIOTRUE for 30 days each

Intervention: OPTI-FREE® PUREMOIST® MPDS (Device)

Air Optix Aqua

Experimental

Lotrafilcon B contact lenses with OFPM and BIOTRUE for 30 days each

Intervention: BIOTRUE® (Device)

Air Optix Aqua

Experimental

Lotrafilcon B contact lenses with OFPM and BIOTRUE for 30 days each

Intervention: ReNu® Multiplus® (Device)