Clinical trial NCT03026257: Clinical Assessment of a HYDRAGLYDE® Regimen
Official title: Clinical Assessment of a Regimen of AIR OPTIX® Plus HYDRAGLYDE® Silicone Hydrogel Lenses and HYDRAGLYDE® Containing Lens Care Solutions
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Refractive Errors
Myopia
Hypermetropia
Lead sponsor: Alcon Research
Sponsor class: INDUSTRY
First posted: 2017-01-20
Enrollment: 323
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.


Eligibility criteria: 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.

Primary outcomes:
measure: Ex Vivo Total Cholesterol Uptake at Day 30
timeFrame: Day 30
Secondary outcomes:
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: Alcon Investigative Site
state: Alabama
city: Cleveland
country: United States
facility: Alcon Investigative Site
state: Ohio
city: Columbus
country: United States
facility: Alcon Investigative Site
state: Ohio
city: Memphis
country: United States
facility: Alcon Investigative Site
state: Tennessee
city: Houston
country: United States
facility: Alcon Investigative Site
state: Texas
city: Waterloo
country: Canada
facility: Alcon Investigative Site
state: Ontario
city: Hildesheim
country: Germany
facility: Alcon Investigative Site
city: Jena
country: Germany
facility: Alcon Investigative Site
Study officials:
affiliation: Alcon, A Novartis Division
name: Clinical Manager, Global Med Affairs, GCRA
role: STUDY_DIRECTOR
References:
citation: 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.