Clinical Assessment of a HYDRAGLYDE® Regimen

Summary

The purpose of this study is to evaluate worn AIR OPTIX® plus HYDRAGLYDE® (AOHG) lenses cleaned and disinfected with HYDRAGLYDE® containing lens solutions compared to each of the control habitual silicone hydrogel (SiHy) lenses cleaned and disinfected with habitual multi-purpose solution (MPS) for cholesterol uptake.

Conditions

• Refractive Errors
• Myopia
• Hypermetropia

Interventions

DEVICE

Lotrafilcon B contact lenses with added wetting agent

Silicone hydrogel contact lenses

DEVICE

Samfilcon A contact lenses

Habitual silicone hydrogel contact lenses

DEVICE

POLYQUAD/ALDOX-preserved contact lens solution with added wetting agent

Multi-purpose disinfecting solution for contact lens care

DEVICE

Hydrogen peroxide-based contact lens solution with added wetting agent

Solution for contact lens cleaning and disinfecting

DEVICE

Senofilcon C contact lenses

Habitual silicone hydrogel contact lenses

DEVICE

Senofilcon A contact lenses

Habitual silicone hydrogel contact lenses with a replacement pair issued after 2 weeks

DEVICE

Comfilcon A contact lenses

Habitual silicone hydrogel contact lenses

DEVICE

Habitual Multi-Purpose Solution (HMPS)

Multi-purpose solution for contact lens care according to participant's habitual brand, used per manufacturer's instructions

Sponsors & Collaborators

• Alcon, a Novartis Company

  lead INDUSTRY

Principal Investigators

• Clinical Manager, Global Med Affairs, GCRA · Alcon, A Novartis Division

Study Design

Allocation

RANDOMIZED

Purpose

SUPPORTIVE_CARE

Masking

DOUBLE

Model

PARALLEL

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2017-02-13

Primary Completion

2017-08-18

Completion

2017-08-18

FDA Device

Yes

Countries

• United States
• Canada
• Germany

Study Locations