Clinical Assessment of a HYDRAGLYDE® Regimen

Not Applicable

Completed

Conditions: Hypermetropia
Refractive Errors
Myopia

Interventions: Device: Lotrafilcon B contact lenses with added wetting agent
Device: Samfilcon A contact lenses
Device: Senofilcon C contact lenses
Device: POLYQUAD/ALDOX-preserved contact lens solution with added wetting agent
Device: Hydrogen peroxide-based contact lens solution with added wetting agent
Device: Senofilcon A contact lenses
Device: Comfilcon A contact lenses
Device: Habitual Multi-Purpose Solution (HMPS)

Registration Number: NCT03026257

Lead Sponsor: Alcon, a Novartis Company

Brief 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.

Detailed Description: Not available

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 323

Inclusion Criteria

Must sign informed consent document;
Vision correctable to 0.1 (LogMAR) or better in each eye at distance with habitual lenses;
Manifest cylinder (at screening) less than or equal to 0.75 diopter (D) in each eye and spectacle add <+0.50 D in each eye;
Current full-time wearer of spherical samfilcon A, comfilcon A, senofilcon C monthly or senofilcon A 2-week replacement lens within the power range of lens powers available;
Current user of an MPS (excluding OFPM) to care for lenses;
Willing to answer text messages on a daily basis during the study;
Willing to discontinue artificial tears during the study and rewetting drops on the days of study visits;
Use of digital devices (eg, smart phone, tablet, laptop or desktop computer) for 20 consecutive minutes at least twice a week and willing to continue for the duration of the study;
Other protocol specific inclusion criteria may apply.

Exclusion Criteria

Habitual lens wear in an extended wear modality (routinely sleeping in lenses overnight for 1 or more nights per week);
Any anterior segment infection, inflammation, disease or abnormality that contraindicates contact lens wear;
History of herpetic keratitis, corneal surgery or irregular cornea;
Prior refractive surgery;
Any use of systemic or ocular medications for which contact lens wear could be contraindicated as determined by the investigator;
Currently using or have not discontinued Restasis®, Xiidra™ and/or topical steroids within the past 7 days;
Use of mechanical eyelid therapy or eyelid scrubs within 14 days before Visit 1 and not willing to discontinue during the study;
Monocular (only 1 eye with functional vision) or fit with only 1 lens;
Known pregnancy or lactating;
Other protocol specific exclusion criteria may apply.

Study & Design

Study Type: INTERVENTIONAL

Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Habitual	Habitual Multi-Purpose Solution (HMPS)	Habitual silicone hydrogel contact lenses worn bilaterally for 30 days in a daily wear modality and cared for with participant's habitual multi-purpose solution (MPS)
AOHG	Lotrafilcon B contact lenses with added wetting agent	Lotrafilcon B contact lenses with added wetting agent, worn bilaterally (in both eyes) for 30 days in a daily wear modality and cared for with either a hydrogen peroxide-based contact lens solution with added wetting agent or a POLYQUAD/ALDOX-preserved contact lens solution with added wetting agent, as randomized
Habitual	Samfilcon A contact lenses	Habitual silicone hydrogel contact lenses worn bilaterally for 30 days in a daily wear modality and cared for with participant's habitual multi-purpose solution (MPS)
Habitual	Senofilcon C contact lenses	Habitual silicone hydrogel contact lenses worn bilaterally for 30 days in a daily wear modality and cared for with participant's habitual multi-purpose solution (MPS)
Habitual	Comfilcon A contact lenses	Habitual silicone hydrogel contact lenses worn bilaterally for 30 days in a daily wear modality and cared for with participant's habitual multi-purpose solution (MPS)
AOHG	POLYQUAD/ALDOX-preserved contact lens solution with added wetting agent	Lotrafilcon B contact lenses with added wetting agent, worn bilaterally (in both eyes) for 30 days in a daily wear modality and cared for with either a hydrogen peroxide-based contact lens solution with added wetting agent or a POLYQUAD/ALDOX-preserved contact lens solution with added wetting agent, as randomized
AOHG	Hydrogen peroxide-based contact lens solution with added wetting agent	Lotrafilcon B contact lenses with added wetting agent, worn bilaterally (in both eyes) for 30 days in a daily wear modality and cared for with either a hydrogen peroxide-based contact lens solution with added wetting agent or a POLYQUAD/ALDOX-preserved contact lens solution with added wetting agent, as randomized
Habitual	Senofilcon A contact lenses	Habitual silicone hydrogel contact lenses worn bilaterally for 30 days in a daily wear modality and cared for with participant's habitual multi-purpose solution (MPS)

Primary Outcome Measures

Name	Time	Method
Ex Vivo Total Cholesterol Uptake at Day 30	Day 30	The contact lens worn in the right eye was removed and stored dry and frozen until analysis. Total cholesterol uptake (cholesterol and cholesterol esters) was evaluated from a sample of the right contact lenses from each site and measured in micrograms. Lower total cholesterol uptake indicates increased lens performance.

Secondary Outcome Measures