Clinical Assessment of a HYDRAGLYDE® Regimen

NCT03026257 | Completed Results FDA Device

• 1 other identifier: LCW773-P001
• Study Type: interventional
• Target: 323
• Locations: 3 countries
• Sites: 8

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.

Conditions

Refractive Errors; Myopia; Hypermetropia

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (2)

AOHG

EXPERIMENTAL

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; Device: POLYQUAD/ALDOX-preserved contact lens solution with added wetting agent; Device: Hydrogen peroxide-based contact lens solution with added wetting agent

Habitual

ACTIVE COMPARATOR

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; Device: Senofilcon C contact lenses; Device: Senofilcon A contact lenses; Device: Comfilcon A contact lenses; Device: Habitual Multi-Purpose Solution (HMPS)

Interventions

Lotrafilcon B contact lenses with added wetting agent DEVICE

Silicone hydrogel contact lenses

Also known as: AIR OPTIX® plus HYDRAGLYDE® (AOHG)

AOHG

Samfilcon A contact lenses DEVICE

Habitual silicone hydrogel contact lenses

Also known as: Bausch + Lomb ULTRA™ (Ultra)

Habitual

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

Multi-purpose disinfecting solution for contact lens care

Also known as: OPTI-FREE® PureMoist® (OFPM)

AOHG

Hydrogen peroxide-based contact lens solution with added wetting agent DEVICE

Solution for contact lens cleaning and disinfecting

Also known as: CLEAR CARE® PLUS/AOSEPT® PLUS with HYDRAGLYDE® (CCP)

AOHG

Senofilcon C contact lenses DEVICE

Habitual silicone hydrogel contact lenses

Also known as: Johnson & Johnson ACUVUE® VITA™ (Vita)

Habitual

Senofilcon A contact lenses DEVICE

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

Also known as: Johnson & Johnson ACUVUE® OASYS® 2- Week with HYDRACLEAR® PLUS (Oasys)

Habitual

Comfilcon A contact lenses DEVICE

Habitual silicone hydrogel contact lenses

Also known as: CooperVision® Biofinity® (Biofinity)

Habitual

Habitual Multi-Purpose Solution (HMPS) DEVICE

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

Habitual

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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;

You may not qualify if:

• 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;

Sponsors & Collaborators

• Alcon, a Novartis Company: lead

Study Sites (8)

Alcon Investigative Site

Birmingham, Alabama, 35233, United States

Location

Alcon Investigative Site

Cleveland, Ohio, 44106, United States

Location

Alcon Investigative Site

Columbus, Ohio, 43210, United States

Location

Alcon Investigative Site

Memphis, Tennessee, 38104, United States

Location

Alcon Investigative Site

Houston, Texas, 77204, United States

Location

Alcon Investigative Site

Waterloo, Ontario, N2L3G1, Canada

Location

Alcon Investigative Site

Hildesheim, 31134, Germany

Location

Alcon Investigative Site

Jena, 07745, Germany

Location

Related Publications (1)

• 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.

  PMID: 32769842 DERIVED

MeSH Terms

Conditions

Refractive Errors; Myopia; Hyperopia

Condition Hierarchy (Ancestors)

Eye Diseases

Results Point of Contact

• Title: Senior Clinical Project Lead, GCRA - Clin Dev Vision Care
• Organization: Alcon, A Novartis Division

alcon.medinfo@alcon.com

1-888-451-3937

Study Officials

• Clinical Manager, Global Med Affairs, GCRA

  Alcon, A Novartis Division

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 18, 2017
• First Posted: January 20, 2017
• Study Start: February 13, 2017
• Primary Completion: August 18, 2017
• Study Completion: August 18, 2017
• Last Updated: August 14, 2018
• Results First Posted: August 14, 2018

Record last verified: 2018-07

Locations

DE (2); US (5); CA (1)