Refractive ErrorNCT02495948

Comparison of Two Marketed Silicone Hydrogel Lenses

A study testing Lotrafilcon B contact lenses, Samfilcon A contact lenses and Hydrogen peroxide solution in people with Refractive Error, run by Alcon Research.

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 evaluate cholesterol sorption by AIR OPTIX® AQUA lenses compared to ULTRA lenses after 30 days of wear. 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, Samfilcon A contact lenses and Hydrogen peroxide solution
Type of treatment: Medical device
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 168 participants
Where: No sites listed yet
Study dates: Jul 2015to Oct 2015
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 document;
Vision correctable to 20/40 Snellen (feet) or better in each eye at distance with both study contact lenses;
Willing to wear study lenses on a daily basis (minimum 5 days/week, 8 hours/day) and attend all study visits;
Successful wear of single-vision spherical, 2-week/ monthly replacement silicone hydrogel contact lenses in both eyes daily wear during the past 2 months for a minimum of 5 days/week, 8 hours/day. (Note: Monovision is included);
Other protocol-specified inclusion criteria may apply.

Who cannot join

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 within the past 30 days for which contact lens wear could be contraindicated as determined by the investigator;
Monocular (only 1 eye with functional vision) or fit with only one lens;
Current or past AIR OPTIX® AQUA or ULTRA lens wearers;
Other protocol-specified exclusion criteria may apply.

About this study

Official title: One Month Clinical Comparison of Lotrafilcon B and Samfilcon A

The purpose of this study is to evaluate cholesterol sorption by AIR OPTIX® AQUA lenses compared to ULTRA lenses after 30 days of wear.

Conditions: Refractive Error
Being tested: Lotrafilcon B contact lenses, Samfilcon A contact lenses, Hydrogen peroxide solution, Saline solution
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® AQUA
Samfilcon A contact lensesDevice
Also called Bausch + Lomb ULTRA
Hydrogen peroxide solutionDevice
Also called CLEAR CARE®
Used as a cleaning, disinfection, and storage solution for silicone hydrogel and soft contact lenses
Saline solutionDevice
Also called SENSITIVE EYES® PLUS
Used for rinsing contact lenses, as needed

Study groups in NCT02495948
Study group	Role	What they receive
AOA then ULTRA	Other	Lotrafilcon B contact lenses worn first, followed by samfilcon A contact lenses. Each product worn bilaterally (in both eyes) for a minimum of 5 days/week, 8 hours/day for 30 days in a daily wear modality. Receives: Device: Lotrafilcon B contact lenses; Device: Samfilcon A contact lenses; Device: Hydrogen peroxide solution; Device: Saline solution
ULTRA then AOA	Other	Samfilcon A contact lenses worn first, followed by lotrafilcon B contact lenses. Each product worn bilaterally for a minimum of 5 days/week, 8 hours/day for 30 days in a daily wear modality. Receives: Device: Lotrafilcon B contact lenses; Device: Samfilcon A contact lenses; Device: Hydrogen peroxide solution; Device: Saline solution

What is being measured

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

Mean Ex-vivo Cholesterol Deposits After 30 Days of Wear
The contact lens (right eye) was removed and stored dry and frozen until analysis. Total cholesterol deposits (cholesterol and cholesterol esters) were extracted from the lens and measured in micrograms. Lower deposits indicate increased lens performance. Study originally intended to analyze 36 lenses per arm, but actual number of lenses analyzed was less due to measurement error.
Measured: Day 30, each product

Timeline

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

Jul 2015Oct 2015

First posted13 Jul 2015 (estimated)
Study startJul 2015
Primary completionOct 2015
Study completionOct 2015

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
Allocation: Randomised
Intervention model: Crossover
Masking: Single blind
Who is masked: Participant
Enrolment: 168 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02495948
Sponsor's protocol ID: CLA560-P001
Status last verified: Nov 2016
First submitted: 9 Jul 2015
Last updated: 28 Dec 2016
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: 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?

Official record

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All Refractive Error trials

Study at a glance

From the registry record, last updated by the sponsor on 28 Dec 2016. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: One Month Clinical Comparison of Lotrafilcon B and Samfilcon A
ClinicalTrials.gov ID: NCT02495948
Acronym / sponsor ID: CLA560-P001
Conditions: Refractive Error
Study type: Interventional
Recruitment status: Completed
Enrolment: 168 participants (actual)
Lead sponsor: Alcon ResearchIndustry (pharma, biotech, devices)
Study start: Jul 2015
Primary completion: Oct 2015 (actual)
Study completion: Oct 2015 (actual)
First posted: 13 Jul 2015 (estimated)
Results: Posted 19 Oct 2016

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 cholesterol sorption by AIR OPTIX® AQUA lenses compared to ULTRA lenses after 30 days of wear.

Study design

Allocation: Randomised
Intervention model: Crossover
Masking: Single blind (participant)
Number of arms: 2

Arm	Type	Receives
AOA then ULTRA	Other	Device: Lotrafilcon B contact lenses, Device: Samfilcon A contact lenses, Device: Hydrogen peroxide solution, Device: Saline solutionLotrafilcon B contact lenses worn first, followed by samfilcon A contact lenses. Each product worn bilaterally (in both eyes) for a minimum of 5 days/week, 8 hours/day for 30 days in a daily wear modality.
ULTRA then AOA	Other	Device: Lotrafilcon B contact lenses, Device: Samfilcon A contact lenses, Device: Hydrogen peroxide solution, Device: Saline solutionSamfilcon A contact lenses worn first, followed by lotrafilcon B contact lenses. Each product worn bilaterally for a minimum of 5 days/week, 8 hours/day for 30 days in a daily wear modality.

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 document;
Vision correctable to 20/40 Snellen (feet) or better in each eye at distance with both study contact lenses;
Willing to wear study lenses on a daily basis (minimum 5 days/week, 8 hours/day) and attend all study visits;
Successful wear of single-vision spherical, 2-week/ monthly replacement silicone hydrogel contact lenses in both eyes daily wear during the past 2 months for a minimum of 5 days/week, 8 hours/day. (Note: Monovision is included);
Other protocol-specified inclusion criteria may apply.

Key exclusion criteria (6 listed)

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 within the past 30 days for which contact lens wear could be contraindicated as determined by the investigator;
Monocular (only 1 eye with functional vision) or fit with only one lens;
Current or past AIR OPTIX® AQUA or ULTRA lens wearers;

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® AQUA	Device	AOA then ULTRA, ULTRA then AOA
Samfilcon A contact lensesAlso: Bausch + Lomb ULTRA	Device	AOA then ULTRA, ULTRA then AOA
Hydrogen peroxide solutionAlso: CLEAR CARE®Used as a cleaning, disinfection, and storage solution for silicone hydrogel and soft contact lenses	Device	AOA then ULTRA, ULTRA then AOA
Saline solutionAlso: SENSITIVE EYES® PLUSUsed for rinsing contact lenses, as needed	Device	AOA then ULTRA, ULTRA then AOA

Primary outcome

Mean Ex-vivo Cholesterol Deposits After 30 Days of Wear
Time frame: Day 30, each product
The contact lens (right eye) was removed and stored dry and frozen until analysis. Total cholesterol deposits (cholesterol and cholesterol esters) were extracted from the lens and measured in micrograms. Lower deposits indicate increased lens performance. Study originally intended to analyze 36 lenses per arm, but actual number of lenses analyzed was less due to measurement error.

Results and safety

Results posted to the registry on 19 Oct 2016, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
AOA Then ULTRA	83	83
ULTRA Then AOA	84	83

Primary outcome: Mean Ex-vivo Cholesterol Deposits After 30 Days of Wear

Time frame: Day 30, each product. Mean (Standard Deviation). Unit: micrograms

Measure	AIR OPTIX AQUA (AOA) n = 167	ULTRA n = 167
Value	1.63 (2.21)	4.89 (3.12)

Population analysed: Intent-to-Treat analysis set

Adverse events

Time frame: Adverse events (AEs) were collected from time of informed consent throughout the duration of a subject's participation in the study (at least 62 days). AEs are reported as pre-treatment and treatment-emergent. Ocular AEs are presented for both study eye and non-study eye combined.. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Pretreatment	0 of 168 (0%)	0 of 168 (0%)	Not reported
AIR OPTIX AQUA	0 of 166 (0%)	0 of 166 (0%)	Not reported
ULTRA	0 of 167 (0%)	0 of 167 (0%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 28 Dec 2016.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

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
Astigmatism
RecruitingPhase 1/2
Psilocybin for Amblyopia - Targeting Critical Periods in Humans
Amblyopia
Recruiting
Evaluation of a New Laser Refractive Vision Correction Using the TENEO™ 317 Model 2
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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 Trial Manager, Vision Care, GCRA study director

Alcon, A Novartis Division

Questions about this trial

What is this clinical trial studying?

A study testing Lotrafilcon B contact lenses, Samfilcon A contact lenses and Hydrogen peroxide solution in people with Refractive Error, run by Alcon Research.

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 6 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 28 Dec 2016. Status can change between updates, so confirm with the study contact before making plans.

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 19 Oct 2016). 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 Cholesterol Deposits After 30 Days of Wear (time frame: Day 30, 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 NCT02495948.

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 28 Dec 2016.