Refractive ErrorNCT03169153

Clinical Comparison of Silicone Hydrogel Monthly Lenses

A study testing Lotrafilcon B contact lenses and Senofilcon C contact lenses in people with Refractive Error, run by Alcon Research at 1 site in United Kingdom.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

The purpose of this study is to compare AIR OPTIX® plus HydraGlyde (AOHG) contact lenses to ACUVUE® VITA® (VITA) contact lenses for total lipid uptake (total of surface and bulk uptake) after 30 days of wear by high lipid depositors. Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Refractive Error
What is being tested?: Lotrafilcon B contact lenses and Senofilcon C contact lenses
Type of treatment: Medical device
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 114 participants
Where: 1 siteUnited Kingdom
Study dates: 22 Sep 2017to 19 Jul 2018
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

Sign Informed Consent;
Best corrected visual acuity (BCVA) of at least 0.1 logarithm of the minimum angle of resolution (logMAR) in each eye at Visit 1;
Manifest cylinder less than or equal to 0.75 diopter (D) in each eye at Visit 1;
Successful current wearer (during the past 2 months for a minimum of 5 days per week and 8 hours per day) of monthly replacement silicone hydrogel lenses within the power range of lens powers available for the screening and study lenses;
Screening lenses worn 10 hours exhibiting high lipid uptake.

Who cannot join

Habitual lens used in an extended wear modality (routinely sleeping in lenses overnight for 1 night per week or more) during the past 2 months;
Habitually wearing AIR OPTIX AQUA, AIR OPTIX plus HydraGlyde, ACUVUE OASYS®, or ACUVUE VITA as contact lenses during the past 2 months;
Any anterior segment infection, inflammation, disease or abnormality that contraindicates contact lens wear (within 7 days of enrollment, or current)
History of herpetic keratitis, corneal surgery, or irregular cornea;
Any use of systemic or ocular medications for which contact lens wear could be contraindicated, as determined by the Investigator;
Abnormal ocular conditions or findings, as specified in the protocol;
Known pregnancy and lactation.

Trial locations and contacts

1 site in 1 country.

United Kingdom1 site

Alcon Investigative Site
London, SW1E 6AU

Other trials in United Kingdom

About this study

Official title: One-month Clinical Comparison of Silicone Hydrogel Monthly Lenses in High Lipid Depositors

Conditions: Refractive Error
Being tested: Lotrafilcon B contact lenses, Senofilcon C contact lenses
Keywords: contact lenses, lipids, deposits
Medical subject headings: Refractive Errors

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Lotrafilcon B contact lensesDevice
Also called AIR OPTIX® plus HydraGlyde
Silicone hydrogel contact lenses used as per their Conformité Européenne (CE) marking
Senofilcon C contact lensesDevice
Also called ACUVUE® VITA®
Silicone hydrogel contact lenses used as per their Conformité Européenne (CE) marking

Study groups in NCT03169153
Study group	Role	What they receive
Lotrafilcon B, then senofilcon C	Other	Lotrafilcon B contact lenses worn first, followed by senofilcon C contact lenses, as randomized. Each product worn bilaterally (in both eyes) for a total duration of 30 (+ 3) days under a daily wear modality for the specific study period. The lenses will be removed every night and cared for with the subject's habitual lens care solution. Receives: Device: Lotrafilcon B contact lenses; Device: Senofilcon C contact lenses
Senofilcon C, then lotrafilcon B	Other	Senofilcon C contact lenses worn first, followed by lotrafilcon B contact lenses, as randomized. Each product worn bilaterally (in both eyes) for a total duration of 30 (+ 3) days under a daily wear modality for the specific study period. The lenses will be removed every night and cared for with the subject's habitual lens care solution. Receives: Device: Lotrafilcon B contact lenses; Device: Senofilcon C contact lenses

What is being measured

The primary outcome is the main question the study is designed to answer.

Mean Ex-vivo Total Lipid Uptake (Total of Surface and Bulk Uptake) Per Lens
Contact lens was removed aseptically from the eye. Total lipid (fatty deposits) uptake, defined as total amount of lipids (surface and bulk) absorbed/adsorbed and extracted, was measured in micrograms. A lower value indicates better results. Only one lens from each subject contributed to the analysis.
Measured: Day 30 after 10 hours of wear, each product

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

22 Sep 201719 Jul 2018

First posted30 May 2017
Study start22 Sep 2017
Primary completion19 Jul 2018
Study completion19 Jul 2018

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.
Other trials for Refractive ErrorStudies of the same condition, open and under way.
More trials run by Alcon ResearchThe sponsor's other registered studies.
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: Treatment
Allocation: Randomised
Intervention model: Crossover
Masking: Double blind
Who is masked: Participant, Investigator
Enrolment: 114 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT03169153
Sponsor's protocol ID: CLL541-P001
Status last verified: May 2019
First submitted: 25 May 2017
Last updated: 25 Jul 2019
Results posted: Yes, on ClinicalTrials.gov
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Refractive Error trials

Study at a glance

From the registry record, last updated by the sponsor on 25 Jul 2019. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: One-month Clinical Comparison of Silicone Hydrogel Monthly Lenses in High Lipid Depositors
ClinicalTrials.gov ID: NCT03169153
Acronym / sponsor ID: CLL541-P001
Conditions: Refractive Error
Keywords: contact lenses, lipids, deposits
Study type: Interventional
Recruitment status: Completed
Enrolment: 114 participants (actual)
Lead sponsor: Alcon ResearchIndustry (pharma, biotech, devices)
Study start: 22 Sep 2017 (actual)
Primary completion: 19 Jul 2018 (actual)
Study completion: 19 Jul 2018 (actual)
First posted: 30 May 2017 (actual)
Results: Posted 25 Jul 2019

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Crossover
Masking: Double blind (participant, investigator)
Number of arms: 2

Arm	Type	Receives
Lotrafilcon B, then senofilcon C	Other	Device: Lotrafilcon B contact lenses, Device: Senofilcon C contact lensesLotrafilcon B contact lenses worn first, followed by senofilcon C contact lenses, as randomized. Each product worn bilaterally (in both eyes) for a total duration of 30 (+ 3) days under a daily wear modality for the specific study period. The lenses will be removed every night and cared for with the subject's habitual lens care solution.
Senofilcon C, then lotrafilcon B	Other	Device: Lotrafilcon B contact lenses, Device: Senofilcon C contact lensesSenofilcon C contact lenses worn first, followed by lotrafilcon B contact lenses, as randomized. Each product worn bilaterally (in both eyes) for a total duration of 30 (+ 3) days under a daily wear modality for the specific study period. The lenses will be removed every night and cared for with the subject's habitual lens care solution.

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (5 listed)

Sign Informed Consent;
Best corrected visual acuity (BCVA) of at least 0.1 logarithm of the minimum angle of resolution (logMAR) in each eye at Visit 1;
Manifest cylinder less than or equal to 0.75 diopter (D) in each eye at Visit 1;
Successful current wearer (during the past 2 months for a minimum of 5 days per week and 8 hours per day) of monthly replacement silicone hydrogel lenses within the power range of lens powers available for the screening and study lenses;
Screening lenses worn 10 hours exhibiting high lipid uptake.

Key exclusion criteria (7 listed)

Habitual lens used in an extended wear modality (routinely sleeping in lenses overnight for 1 night per week or more) during the past 2 months;
Habitually wearing AIR OPTIX AQUA, AIR OPTIX plus HydraGlyde, ACUVUE OASYS®, or ACUVUE VITA as contact lenses during the past 2 months;
Any anterior segment infection, inflammation, disease or abnormality that contraindicates contact lens wear (within 7 days of enrollment, or current)
History of herpetic keratitis, corneal surgery, or irregular cornea;
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 lensesAlso: AIR OPTIX® plus HydraGlydeSilicone hydrogel contact lenses used as per their Conformité Européenne (CE) marking	Device	Lotrafilcon B, then senofilcon C, Senofilcon C, then lotrafilcon B
Senofilcon C contact lensesAlso: ACUVUE® VITA®Silicone hydrogel contact lenses used as per their Conformité Européenne (CE) marking	Device	Lotrafilcon B, then senofilcon C, Senofilcon C, then lotrafilcon B

Primary outcome

Mean Ex-vivo Total Lipid Uptake (Total of Surface and Bulk Uptake) Per Lens
Time frame: Day 30 after 10 hours of wear, each product
Contact lens was removed aseptically from the eye. Total lipid (fatty deposits) uptake, defined as total amount of lipids (surface and bulk) absorbed/adsorbed and extracted, was measured in micrograms. A lower value indicates better results. Only one lens from each subject contributed to the analysis.

Results and safety

Results posted to the registry on 25 Jul 2019, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
AOHG Then VITA	42	39
VITA Then AOHG	39	35

Primary outcome: Mean Ex-vivo Total Lipid Uptake (Total of Surface and Bulk Uptake) Per Lens

Time frame: Day 30 after 10 hours of wear, each product. Mean (Standard Deviation). Unit: micrograms (μg)

Measure	AOHG n = 59	VITA n = 56
Value	78.1398 (70.7923)	307.6800 (303.9299)

AOHG vs VITA: p <0.0001, Mixed effects repeated measures

Population analysed: Full Analysis Set with non-missing response

Adverse events

Time frame: Dispense through study completion, an average of 2.5 months. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
AOHG	0 of 76 (0%)	0 of 76 (0%)	0 of 76
VITA	0 of 78 (0%)	0 of 78 (0%)	0 of 78

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 25 Jul 2019.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Individual participant dataSharing planned: No

Related trials for Refractive Error

Recruiting
Managing Premyopia in Chinese Children Using Artificial Intelligence Assisted Defocus Incorporated Multiple Segments Based Spectacle Lens: a Randomized Controlled Clinical Trial
Pre-myopia, Myopia
Not yet recruiting
BRIGHT-LIGHT: Studying Red Light Therapy for Severe Short-Sightedness or Short-Sightedness That Worsens Despite Standard Treatment
Myopia, Myopia Progressing
Not yet recruiting
Clinical Performance and Outcomes After Toric Lens Transition
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RecruitingPhase 1/2
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Recruiting
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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, Medical Clinical Trial Services study director

Alcon Research

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing Lotrafilcon B contact lenses and Senofilcon C contact lenses in people with Refractive Error, run by Alcon Research at 1 site in United Kingdom.

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 5 inclusion and 7 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 25 Jul 2019. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United Kingdom. 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 25 Jul 2019). 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?

Mean Ex-vivo Total Lipid Uptake (Total of Surface and Bulk Uptake) Per Lens (time frame: Day 30 after 10 hours of wear, each product). 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 NCT03169153.

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 25 Jul 2019.