NCT01699750

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 109 (actual)
• Sponsor: Alcon Research · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Myopia
• Astigmatism
• Refractive Error

Interventions

Type	Name	Description
DEVICE	Lotrafilcon B contact lenses	Silicone hydrogel contact lenses, Phase 2
DEVICE	Senofilcon A contact lenses	Silicone hydrogel contact lenses, Phase 2
DEVICE	OPTI-FREE® PUREMOIST® MPDS	Contact lens care system, Phase 2
DEVICE	BIOTRUE®	Contact lens care system, Phase 2
DEVICE	Balafilcon A contact lenses	Silicone hydrogel contact lenses worn for 30 days, Phase 1
DEVICE	ReNu® Multiplus®	Contact lens care system used for 30 days, Phase 1

Timeline

• Start date: 2012-12-01
• Primary completion: 2013-11-01
• Completion: 2013-11-01
• First posted: 2012-10-04
• Last updated: 2014-12-08
• Results posted: 2014-12-08

Locations

1 site across 1 country: United States