NCT03026257

Clinical Assessment of a HYDRAGLYDE® Regimen

Clinical Assessment of a Regimen of AIR OPTIX® Plus HYDRAGLYDE® Silicone Hydrogel Lenses and HYDRAGLYDE® Containing Lens Care Solutions

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 323 (actual)
• Sponsor: Alcon, a Novartis Company · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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

Type	Name	Description
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

Timeline

• Start date: 2017-02-13
• Primary completion: 2017-08-18
• Completion: 2017-08-18
• First posted: 2017-01-20
• Last updated: 2018-08-14
• Results posted: 2018-08-14

Locations

8 sites across 3 countries: United States, Canada, Germany

Regulatory

• FDA-regulated device study