Refractive ErrorsNCT03026257
Clinical Assessment of a HYDRAGLYDE® Regimen
A study testing Lotrafilcon B contact lenses with added wetting agent, Samfilcon A contact lenses and POLYQUAD/ALDOX-preserved contact lens solution with added wetting agent in people with Refractive Errors and Myopia, run by Alcon, a Novartis Company at 8 sites in 3 countries.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Refractive Errors, Myopia, Hypermetropia
- What is being tested?
- Lotrafilcon B contact lenses with added wetting agent, Samfilcon A contact lenses and POLYQUAD/ALDOX-preserved contact lens solution with added wetting agent
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 323 participants
- Where
- 8 sitesin 3 countries
- Study dates
- 13 Feb 2017to 18 Aug 2017
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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;
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- 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.
Who cannot join
- 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;
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- 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.
Trial locations and contacts
8 sites in 3 countries.
8 sites in 3 countries
United States5 sites
Alcon Investigative Site
Birmingham, Alabama, 35233
Alcon Investigative Site
Cleveland, Ohio, 44106
Alcon Investigative Site
Columbus, Ohio, 43210
Alcon Investigative Site
Houston, Texas, 77204
Alcon Investigative Site
Memphis, Tennessee, 38104
Germany2 sites
Alcon Investigative Site
Hildesheim, 31134
Alcon Investigative Site
Jena, 07745
About this study
Official title: 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.
- Conditions
- Refractive Errors, Myopia, Hypermetropia
- Being tested
- Lotrafilcon B contact lenses with added wetting agent, Samfilcon A contact lenses, POLYQUAD/ALDOX-preserved contact lens solution with added wetting agent, Hydrogen peroxide-based contact lens solution with added wetting agent, Senofilcon C contact lenses
- Medical subject headings
- Refractive Errors, Myopia, Hyperopia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Lotrafilcon B contact lenses with added wetting agentDevice
Also called AIR OPTIX® plus HYDRAGLYDE® (AOHG)
Silicone hydrogel contact lenses
Samfilcon A contact lensesDevice
Also called Bausch + Lomb ULTRA™ (Ultra)
Habitual silicone hydrogel contact lenses
POLYQUAD/ALDOX-preserved contact lens solution with added wetting agentDevice
Also called OPTI-FREE® PureMoist® (OFPM)
Multi-purpose disinfecting solution for contact lens care
Hydrogen peroxide-based contact lens solution with added wetting agentDevice
Also called CLEAR CARE® PLUS/AOSEPT® PLUS with HYDRAGLYDE® (CCP)
Solution for contact lens cleaning and disinfecting
Senofilcon C contact lensesDevice
Also called Johnson & Johnson ACUVUE® VITA™ (Vita)
Habitual silicone hydrogel contact lenses
Senofilcon A contact lensesDevice
Also called Johnson & Johnson ACUVUE® OASYS® 2- Week with HYDRACLEAR® PLUS (Oasys)
Habitual silicone hydrogel contact lenses with a replacement pair issued after 2 weeks
Comfilcon A contact lensesDevice
Also called CooperVision® Biofinity® (Biofinity)
Habitual silicone hydrogel contact lenses
Habitual Multi-Purpose Solution (HMPS)Device
Multi-purpose solution for contact lens care according to participant's habitual brand, used per manufacturer's instructions
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: 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) Receives: 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) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Day 30
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jan 2017 (estimated)
- Study start13 Feb 2017
- Primary completion18 Aug 2017
- Study completion18 Aug 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Refractive ErrorsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 323 participants (actual)
Sponsor and investigators
- Lead sponsor
- Alcon, a Novartis Company
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Clinical Manager, Global Med Affairs, GCRA, Study director, Alcon, A Novartis Division
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03026257
- Sponsor's protocol ID
- LCW773-P001
- Status last verified
- Jul 2018
- First submitted
- 18 Jan 2017
- Last updated
- 14 Aug 2018
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
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 at a glance
From the registry record, last updated by the sponsor on 14 Aug 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Assessment of a Regimen of AIR OPTIX® Plus HYDRAGLYDE® Silicone Hydrogel Lenses and HYDRAGLYDE® Containing Lens Care Solutions
- ClinicalTrials.gov ID
- NCT03026257
- Acronym / sponsor ID
- LCW773-P001
- Conditions
- Refractive Errors, Myopia, Hypermetropia
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 323 participants (actual)
- Lead sponsor
- Alcon, a Novartis CompanyIndustry (pharma, biotech, devices)
- Study start
- 13 Feb 2017 (actual)
- Primary completion
- 18 Aug 2017 (actual)
- Study completion
- 18 Aug 2017 (actual)
- First posted
- 20 Jan 2017 (estimated)
- Results
- Posted 14 Aug 2018
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| AOHG | Experimental | 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 agentLotrafilcon 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 |
| Habitual | Active comparator | 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)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) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- 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;
Key exclusion criteria (10 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Lotrafilcon B contact lenses with added wetting agentAlso: AIR OPTIX® plus HYDRAGLYDE® (AOHG)Silicone hydrogel contact lenses | Device | AOHG |
| Samfilcon A contact lensesAlso: Bausch + Lomb ULTRA™ (Ultra)Habitual silicone hydrogel contact lenses | Device | Habitual |
| POLYQUAD/ALDOX-preserved contact lens solution with added wetting agentAlso: OPTI-FREE® PureMoist® (OFPM)Multi-purpose disinfecting solution for contact lens care | Device | AOHG |
| Hydrogen peroxide-based contact lens solution with added wetting agentAlso: CLEAR CARE® PLUS/AOSEPT® PLUS with HYDRAGLYDE® (CCP)Solution for contact lens cleaning and disinfecting | Device | AOHG |
| Senofilcon C contact lensesAlso: Johnson & Johnson ACUVUE® VITA™ (Vita)Habitual silicone hydrogel contact lenses | Device | Habitual |
| Senofilcon A contact lensesAlso: Johnson & Johnson ACUVUE® OASYS® 2- Week with HYDRACLEAR® PLUS (Oasys)Habitual silicone hydrogel contact lenses with a replacement pair issued after 2 weeks | Device | Habitual |
| Comfilcon A contact lensesAlso: CooperVision® Biofinity® (Biofinity)Habitual silicone hydrogel contact lenses | Device | Habitual |
| Habitual Multi-Purpose Solution (HMPS)Multi-purpose solution for contact lens care according to participant's habitual brand, used per manufacturer's instructions | Device | Habitual |
Primary outcome
Ex Vivo Total Cholesterol Uptake at Day 30
Time frame: 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.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Aug 2018.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 32769842Shows 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Clinical Manager, Global Med Affairs, GCRA study director
Alcon, A Novartis Division
8 sites in 3 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Lotrafilcon B contact lenses with added wetting agent, Samfilcon A contact lenses and POLYQUAD/ALDOX-preserved contact lens solution with added wetting agent in people with Refractive Errors and Myopia, run by Alcon, a Novartis Company at 8 sites in 3 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 14 Aug 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 8 sites in United States, Germany, Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 14 Aug 2018). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Ex Vivo Total Cholesterol Uptake at Day 30 (time frame: Day 30). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03026257, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Aug 2018.