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

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.

Study Overview

• Status: Completed
• Conditions: Refractive Errors; Myopia; Hypermetropia
• Intervention / Treatment: Device: Lotrafilcon B contact lenses with added wetting agent; Device: POLYQUAD/ALDOX-preserved contact lens solution with added wetting agent; Device: Hydrogen peroxide-based contact lens solution with added wetting agent; Device: Samfilcon A contact lenses; Device: Senofilcon C contact lenses; Device: Senofilcon A contact lenses; Device: Comfilcon A contact lenses; Device: Habitual Multi-Purpose Solution (HMPS)

• Study Type: Interventional
• Enrollment (Actual): 323
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Canada
  • Ontario
    • Waterloo, Ontario, Canada, N2L3G1
      • Alcon Investigative Site
• Germany
  • Hildesheim, Germany, 31134
    • Alcon Investigative Site
  • Jena, Germany, 07745
    • Alcon Investigative Site
• United States
  • Alabama
    • Birmingham, Alabama, United States, 35233
      • Alcon Investigative Site
  • Ohio
    • Cleveland, Ohio, United States, 44106
      • Alcon Investigative Site
    • Columbus, Ohio, United States, 43210
      • Alcon Investigative Site
  • Tennessee
    • Memphis, Tennessee, United States, 38104
      • Alcon Investigative Site
  • Texas
    • Houston, Texas, United States, 77204
      • Alcon Investigative Site

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: SUPPORTIVE_CARE
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: DOUBLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: AOHG; 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	Device: Lotrafilcon B contact lenses with added wetting agent; Silicone hydrogel contact lenses; Other Names: AIR OPTIX® plus HYDRAGLYDE® (AOHG); Device: POLYQUAD/ALDOX-preserved contact lens solution with added wetting agent; Multi-purpose disinfecting solution for contact lens care; Other Names: OPTI-FREE® PureMoist® (OFPM); Device: Hydrogen peroxide-based contact lens solution with added wetting agent; Solution for contact lens cleaning and disinfecting; Other Names: CLEAR CARE® PLUS/AOSEPT® PLUS with HYDRAGLYDE® (CCP)
ACTIVE_COMPARATOR: Habitual; 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)	Device: Samfilcon A contact lenses; Habitual silicone hydrogel contact lenses; Other Names: Bausch + Lomb ULTRA™ (Ultra); Device: Senofilcon C contact lenses; Habitual silicone hydrogel contact lenses; Other Names: Johnson & Johnson ACUVUE® VITA™ (Vita); Device: Senofilcon A contact lenses; Habitual silicone hydrogel contact lenses with a replacement pair issued after 2 weeks; Other Names: Johnson & Johnson ACUVUE® OASYS® 2- Week with HYDRACLEAR® PLUS (Oasys); Device: Comfilcon A contact lenses; Habitual silicone hydrogel contact lenses; Other Names: CooperVision® Biofinity® (Biofinity); Device: Habitual Multi-Purpose Solution (HMPS); Multi-purpose solution for contact lens care according to participant's habitual brand, used per manufacturer's instructions

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Ex Vivo Total Cholesterol Uptake at 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.	Day 30

Collaborators and Investigators

• Sponsor: Alcon, a Novartis Company
• Investigators: Study Director: Clinical Manager, Global Med Affairs, GCRA, Alcon, A Novartis Division

Publications and helpful links

General Publications

• Shows A, Redfern RL, Sickenberger W, Fogt JS, Schulze M, Lievens C, Szczotka-Flynn L, Schwarz S, Tichenor AA, Marx S, Lemp-Hull JM. Lipid Analysis on Block Copolymer-containing Packaging Solution and Lens Care Regimens: A Randomized Clinical Trial. Optom Vis Sci. 2020 Aug;97(8):565-572. doi: 10.1097/OPX.0000000000001553.

Study record dates

Study Major Dates

• Study Start (ACTUAL): February 13, 2017
• Primary Completion (ACTUAL): August 18, 2017
• Study Completion (ACTUAL): August 18, 2017

Study Registration Dates

• First Submitted: January 18, 2017
• First Submitted That Met QC Criteria: January 18, 2017
• First Posted (ESTIMATE): January 20, 2017

Study Record Updates

• Last Update Posted (ACTUAL): August 14, 2018
• Last Update Submitted That Met QC Criteria: July 20, 2018
• Last Verified: July 1, 2018

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Eye Diseases; Refractive Errors; Hyperopia; Anti-Infective Agents, Local; Anti-Infective Agents; Disinfectants; Pharmaceutical Solutions; Hydrogen Peroxide; Contact Lens Solutions
• Other Study ID Numbers: LCW773-P001

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes