CompletedNCT03026257Updated Aug 14, 2018Results posted

Clinical Assessment of a HYDRAGLYDE® Regimen

An interventional study of Lotrafilcon B contact lenses with added wetting agent and Samfilcon A contact lenses in Refractive Errors, Myopia and Hypermetropia, sponsored by Alcon, a Novartis Company. Completed at 8 sites in 3 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2018-08-14.

Sponsored by Alcon, a Novartis Company · Not applicable, Interventional, and Supportive care

Phase: Not applicable
Study type: Interventional
Enrollment: 323
Allocation: Randomized
Ages: 18 Years and older
Sex: All

Study 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 studied

Refractive Errors
Myopia
Hypermetropia

Browse trials for

Who can participate

Ages eligible: 18 Years and older
Sexes eligible: All
Accepts healthy volunteers: No

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

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 design

Phase: Not applicable
Primary purpose: Supportive care
Allocation: Randomized
Intervention model: Parallel assignment
Masking: Double (Participant, Investigator)
Enrollment: 323 participants (actual)

Study arms

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 · Device: POLYQUAD/ALDOX-preserved contact lens solution with added wetting agent · Device: Hydrogen peroxide-based contact lens solution with added wetting agent
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 · Device: Senofilcon C contact lenses · Device: Senofilcon A contact lenses · Device: Comfilcon A contact lenses · Device: Habitual Multi-Purpose Solution (HMPS)

Interventions

DeviceLotrafilcon B contact lenses with added wetting agent
Silicone hydrogel contact lenses
Also known as: AIR OPTIX® plus HYDRAGLYDE® (AOHG)
DeviceSamfilcon A contact lenses
Habitual silicone hydrogel contact lenses
Also known as: Bausch + Lomb ULTRA™ (Ultra)
DevicePOLYQUAD/ALDOX-preserved contact lens solution with added wetting agent
Multi-purpose disinfecting solution for contact lens care
Also known as: OPTI-FREE® PureMoist® (OFPM)
DeviceHydrogen peroxide-based contact lens solution with added wetting agent
Solution for contact lens cleaning and disinfecting
Also known as: CLEAR CARE® PLUS/AOSEPT® PLUS with HYDRAGLYDE® (CCP)
DeviceSenofilcon C contact lenses
Habitual silicone hydrogel contact lenses
Also known as: Johnson & Johnson ACUVUE® VITA™ (Vita)
DeviceSenofilcon A contact lenses
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)
DeviceComfilcon A contact lenses
Habitual silicone hydrogel contact lenses
Also known as: CooperVision® Biofinity® (Biofinity)
DeviceHabitual Multi-Purpose Solution (HMPS)
Multi-purpose solution for contact lens care according to participant's habitual brand, used per manufacturer's instructions

What researchers measure

Primary outcomes

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.
Time frame: Day 30

Results

Posted Aug 14, 2018

Participant flow

Subjects were recruited from 8 study centers located in the United States (5), Germany (2), and Canada (1).

Participant flow — Overall Study
Milestone	AOHG/CCP	AOHG/OFPM	Biofinity/HMPS	Vita/HMPS	Ultra/HMPS	Oasys/HMPS
Started	60	64	34	25	23	46
Treated	58	65	35	24	23	47
Completed	54	63	34	24	22	46
Not completed	6	1	0	1	1	0
Withdrew: Adverse event	3	0	0	0	0	0
Withdrew: Lost to follow-up	1	0	0	0	0	0
Withdrew: Protocol violation	1	0	0	1	1	0
Withdrew: Withdrawal by subject	1	1	0	0	0	0

Outcome measures

PrimaryEx 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.

Time frame:: Day 30
Reported as:: Mean · μg

Ex Vivo Total Cholesterol Uptake at Day 30
μg	AOHG/CCP	AOHG/OFPM	Biofinity/HMPS	Vita/HMPS	Ultra/HMPS	Oasys/HMPS
Ex Vivo Total Cholesterol Uptake at Day 30	0.28 ± 0.18	0.28 ± 0.48	2.17 ± 1.47	4.18 ± 3.25	2.07 ± 1.48	2.19 ± 2.69

Statistical analysis

AOHG/CCP vs Biofinity/HMPS · General Linear Model · p = <0.0001
AOHG/CCP vs Vita/HMPS · General Linear Model · p = <0.0001
AOHG/CCP vs Ultra/HMPS · General Linear Model · p = <0.0001
AOHG/CCP vs Oasys/HMPS · General Linear Model · p = <0.0001
AOHG/OFPM vs Biofinity/HMPS · General Linear Model · p = <0.0001
AOHG/OFPM vs Vita/HMPS · General Linear Model · p = <0.0001
AOHG/OFPM vs Ultra/HMPS · General Linear Model · p = <0.0001
AOHG/OFPM vs Oasys/HMPS · General Linear Model · p = <0.0001

Adverse events

Collected over Lens insertion (Day 1) through study completion, an average of 30 days. Non-serious events are listed at a 5% frequency threshold.

Adverse event summary by group
Group	Deaths	Serious	Other
AOHG/CCP Ocular	0/116 (0%)	0/116 (0%)	0/116 (0%)
AOHG/CCP Nonocular	0/58 (0%)	0/58 (0%)	0/58 (0%)
AOHG/OFPM Ocular	0/130 (0%)	0/130 (0%)	0/130 (0%)
AOHG/OFPM Nonocular	0/65 (0%)	0/65 (0%)	0/65 (0%)
Habitual SiHy/MPS Ocular	0/258 (0%)	0/258 (0%)	0/258 (0%)
Habitual SiHy/MPS Nonocular	0/129 (0%)	0/129 (0%)	0/129 (0%)

Baseline characteristics

This analysis population includes all randomized and exposed to a study lens on Day 1 or a study regimen (lens and lens care system (LCS)) thereafter (Full Analysis Set).

Age, Continuous
Age, Continuous(years)	AOHG/CCP	AOHG/OFPM	Biofinity/HMPS	Vita/HMPS	Ultra/HMPS	Oasys/HMPS	Total
Mean	27.7 ± 7.0	27.8 ± 6.0	28.2 ± 5.9	28.2 ± 5.7	28.8 ± 7.2	30.4 ± 8.2	28.4 ± 6.8

Sex: Female, Male
Sex: Female, Male(Participants)	AOHG/CCP	AOHG/OFPM	Biofinity/HMPS	Vita/HMPS	Ultra/HMPS	Oasys/HMPS	Total
Female	39	49	22	17	17	35	179
Male	21	15	12	8	6	11	73

Ethnicity (NIH/OMB)
Ethnicity (NIH/OMB)(Participants)	AOHG/CCP	AOHG/OFPM	Biofinity/HMPS	Vita/HMPS	Ultra/HMPS	Oasys/HMPS	Total
Hispanic or Latino	5	1	1	1	1	3	12
Not Hispanic or Latino	54	62	33	24	22	43	238
Unknown or Not Reported	1	1	0	0	0	0	2

Study locations

8 sites

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

References and documents

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. PubMed 32769842 ↗

Study documents

Study protocol · Dec 19, 2016
Statistical analysis plan · Jan 24, 2017

Documents are hosted by the registry — open the source record to download them.

Registry details

Key details

Study ID: NCT03026257
Lead sponsor: Alcon, a Novartis Company
Responsible party: Sponsor
First posted: Jan 20, 2017
Start date: Feb 13, 2017
Primary completion: Aug 18, 2017
Completion: Aug 18, 2017
Results posted: Aug 14, 2018
Last update: Aug 14, 2018

Study contacts

Clinical Manager, Global Med Affairs, GCRA

study director · Alcon, A Novartis Division

Oversight

Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: Yes

View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jul 2018. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Other studies in this condition

Refractive Errors→

Other studies from this sponsor

Alcon, a Novartis Company

Start the discussion