Clinical Assessment of a HYDRAGLYDE® Regimen

Myopia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03026257
• Other study ID #: LCW773-P001
• Status: Completed
• Phase: N/A
• Start date: February 13, 2017
• Est. completion date: August 18, 2017

Study information

• Verified date: July 2018
• Source: Alcon Research
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 323
• Est. completion date: August 18, 2017
• Est. primary completion date: August 18, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Hypermetropia
• Hyperopia
• Myopia
• Refractive Errors

Intervention

Device:
• Lotrafilcon B contact lenses with added wetting agent
Silicone hydrogel contact lenses
• Samfilcon A contact lenses
Habitual silicone hydrogel contact lenses
• POLYQUAD/ALDOX-preserved contact lens solution with added wetting agent
Multi-purpose disinfecting solution for contact lens care
• Hydrogen peroxide-based contact lens solution with added wetting agent
Solution for contact lens cleaning and disinfecting
• Senofilcon C contact lenses
Habitual silicone hydrogel contact lenses
• Senofilcon A contact lenses
Habitual silicone hydrogel contact lenses with a replacement pair issued after 2 weeks
• Comfilcon A contact lenses
Habitual silicone hydrogel contact lenses
• Habitual Multi-Purpose Solution (HMPS)
Multi-purpose solution for contact lens care according to participant's habitual brand, used per manufacturer's instructions

Locations

Country	Name	City	State
Canada	Alcon Investigative Site	Waterloo	Ontario
Germany	Alcon Investigative Site	Hildesheim
Germany	Alcon Investigative Site	Jena
United States	Alcon Investigative Site	Birmingham	Alabama
United States	Alcon Investigative Site	Cleveland	Ohio
United States	Alcon Investigative Site	Columbus	Ohio
United States	Alcon Investigative Site	Houston	Texas
United States	Alcon Investigative Site	Memphis	Tennessee

Sponsors (1)

Lead Sponsor	Collaborator
Alcon, a Novartis Company

Countries where clinical trial is conducted

United States,  Canada,  Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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

External Links

•   Results from the Novartis Clinical Trial Results Website