Clinical Assessment of a HYDRAGLYDE® Regimen

Alcon

Status

Completed

Conditions

Myopia

Refractive Errors

Hypermetropia

Treatments

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

Device: Senofilcon C contact lenses

Device: Samfilcon A contact lenses

Device: Hydrogen peroxide-based contact lens solution with added wetting agent

Device: Lotrafilcon B contact lenses with added wetting agent

Device: Comfilcon A contact lenses

Device: Senofilcon A contact lenses

Device: Habitual Multi-Purpose Solution (HMPS)

Study type

Interventional

Funder types

Industry

Identifiers

NCT03026257

LCW773-P001

Details and patient eligibility

About

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.

Enrollment

323 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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.

Trial design

Primary purpose

Supportive Care

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Double Blind

323 participants in 2 patient groups

AOHG

Experimental group

Description:

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

Treatment: