Refractive ErrorNCT02388763

Clinical Evaluation of MyDay™ and 1-DAY ACUVUE® TruEye®

A study testing Stenfilcon A contact lenses and Narafilcon A contact lenses 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 the functional vision of 2 daily disposable silicone hydrogel contact lenses using Time Controlled Visual Acuity (TCVA) measurements at high luminance and high contrast after 10+/-3 days of wear post 3 hour exposure to a reduced humidity environment. 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?: Stenfilcon A contact lenses and Narafilcon A contact lenses
Type of treatment: Medical device
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 66 participants
Where: No sites listed yet
Study dates: Apr 2015to Sep 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

Must sign informed consent form.
Adapted, current soft silicone hydrogel daily disposable contact lens wearer during the last 2 months.
Willing to wear lenses every day or at least 5 days per week 6 hours per day.
Willing to discontinue artificial tears and rewetting drops usage on the days of study visits.
Other protocol-specified inclusion criteria may apply.

Who cannot join

Monocular (only 1 eye with functional vision) or fit with only 1 lens.
Pregnant or lactating.
Current MyDay™ or 1DAY ACUVUE® TruEye® lens wearer.
Any abnormal ocular condition as specified in the protocol.
Other protocol-specified exclusion criteria may apply.

About this study

Official title: Clinical Evaluation of MyDay™ Daily Disposable Silicone Hydrogel Contact Lenses

Read the detailed description

After randomization, participants attended a baseline visit to include a 3 hour exposure to reduced humidity environment. The participant's habitual lenses were worn for the baseline visit.

Conditions: Refractive Error
Being tested: Stenfilcon A contact lenses, Narafilcon A contact lenses
Keywords: Contact lenses
Medical subject headings: Refractive Errors

What participants receive

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

Stenfilcon A contact lensesDevice
Also called MyDay™
Contact lenses worn during Period 1 or 2, as randomized
Narafilcon A contact lensesDevice
Also called 1-DAY ACUVUE® TruEye®
Contact lenses worn during Period 1 or 2, as randomized

Study groups in NCT02388763
Study group	Role	What they receive
MyDay, then 1DAVTE	Other	Stenfilcon A contact lenses, followed by narafilcon A contact lenses. Each product worn bilaterally (in both eyes) for 10 days in a daily wear, daily disposable modality. Receives: Device: Stenfilcon A contact lenses; Device: Narafilcon A contact lenses
1DAVTE, then MyDay	Other	Narafilcon A contact lenses, followed by stenfilcon A contact lenses. Each product worn bilaterally for 10 days in a daily wear, daily disposable modality. Receives: Device: Stenfilcon A contact lenses; Device: Narafilcon A contact lenses

What is being measured

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

High Contrast Time-Controlled Visual Acuity (TCVA) (VA Unit) Post-Exposure to Reduced Humidity at Day 10
High contrast TCVA was assessed after 3 hours exposure to reduced humidity environment. TCVA test was performed at 4 meters under high illumination (90%) using a Landolt ring test. For each acuity level, a series of single rings with gaps in one of four directions was presented and the percentage of correctly identified rings constituted the score. TCVA was measured in VA units and a higher TCVA value indicates an improvement in visual acuity. Both eyes contributed to the analysis.
Measured: Day 10, each product

Secondary outcomes (1)

High Contrast TCVA (VA Unit) Pre-Exposure to Reduced Humidity at Day 10
High contrast TCVA was assessed after 3 hours exposure to normal environment and prior to exposure to reduced humidity environment. Both eyes contributed to the analysis.
Measured: Day 10, each product

Timeline

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

Apr 2015Sep 2015

First posted17 Mar 2015 (estimated)
Study startApr 2015
Primary completionSep 2015
Study completionSep 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
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Crossover
Masking: Single blind
Who is masked: Outcomes assessor
Enrolment: 66 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02388763
Sponsor's protocol ID: CLY838-P001
Status last verified: Oct 2016
First submitted: 10 Mar 2015
Last updated: 5 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 5 Dec 2016. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Clinical Evaluation of MyDay™ Daily Disposable Silicone Hydrogel Contact Lenses
ClinicalTrials.gov ID: NCT02388763
Acronym / sponsor ID: CLY838-P001
Conditions: Refractive Error
Keywords: Contact lenses
Study type: Interventional
Recruitment status: Completed
Enrolment: 66 participants (actual)
Lead sponsor: Alcon ResearchIndustry (pharma, biotech, devices)
Study start: Apr 2015
Primary completion: Sep 2015 (actual)
Study completion: Sep 2015 (actual)
First posted: 17 Mar 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.

Detailed description

After randomization, participants attended a baseline visit to include a 3 hour exposure to reduced humidity environment. The participant's habitual lenses were worn for the baseline visit.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Crossover
Masking: Single blind (outcomes assessor)
Number of arms: 2

Arm	Type	Receives
MyDay, then 1DAVTE	Other	Device: Stenfilcon A contact lenses, Device: Narafilcon A contact lensesStenfilcon A contact lenses, followed by narafilcon A contact lenses. Each product worn bilaterally (in both eyes) for 10 days in a daily wear, daily disposable modality.
1DAVTE, then MyDay	Other	Device: Stenfilcon A contact lenses, Device: Narafilcon A contact lensesNarafilcon A contact lenses, followed by stenfilcon A contact lenses. Each product worn bilaterally for 10 days in a daily wear, daily disposable 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)

Must sign informed consent form.
Adapted, current soft silicone hydrogel daily disposable contact lens wearer during the last 2 months.
Willing to wear lenses every day or at least 5 days per week 6 hours per day.
Willing to discontinue artificial tears and rewetting drops usage on the days of study visits.
Other protocol-specified inclusion criteria may apply.

Key exclusion criteria (5 listed)

Monocular (only 1 eye with functional vision) or fit with only 1 lens.
Pregnant or lactating.
Current MyDay™ or 1DAY ACUVUE® TruEye® lens wearer.
Any abnormal ocular condition as specified in the protocol.
Other protocol-specified exclusion criteria may apply.

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
Stenfilcon A contact lensesAlso: MyDay™Contact lenses worn during Period 1 or 2, as randomized	Device	1DAVTE, then MyDay, MyDay, then 1DAVTE
Narafilcon A contact lensesAlso: 1-DAY ACUVUE® TruEye®Contact lenses worn during Period 1 or 2, as randomized	Device	1DAVTE, then MyDay, MyDay, then 1DAVTE

Primary outcome

High Contrast Time-Controlled Visual Acuity (TCVA) (VA Unit) Post-Exposure to Reduced Humidity at Day 10
Time frame: Day 10, each product
High contrast TCVA was assessed after 3 hours exposure to reduced humidity environment. TCVA test was performed at 4 meters under high illumination (90%) using a Landolt ring test. For each acuity level, a series of single rings with gaps in one of four directions was presented and the percentage of correctly identified rings constituted the score. TCVA was measured in VA units and a higher TCVA value indicates an improvement in visual acuity. Both eyes contributed to the analysis.

1 secondary outcome

High Contrast TCVA (VA Unit) Pre-Exposure to Reduced Humidity at Day 10
Time frame: Day 10, each product

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
Habitual, MyDay, 1DAVTE	32	31
Habitual, 1DAVTE, MyDay	32	31

Primary outcome: High Contrast Time-Controlled Visual Acuity (TCVA) (VA Unit) Post-Exposure to Reduced Humidity at Day 10

Time frame: Day 10, each product. Mean (Standard Deviation). Unit: VA unit

Measure	MyDay n = 60	1DAVTE n = 60
Value	0.453 (0.673)	0.341 (0.781)

Population analysed: Intent to Treat

1 secondary outcome is reported in the full results.

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 (up to 30 days). This analysis population includes all randomized participants exposed to investigational product (habitual, MyDay, and 1DAVTE) from time of product dispense (safety analysis set), based on treatment-specific exposure. One subject in the MyDay/1DAVTE arm wore habitual lenses during Period 1 and was not exposed to MyDay (discontinued at Period 1).. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Pretreatment	0 of 66 (0%)	0 of 66 (0%)	Not reported
Dailies Total 1	0 of 32 (0%)	5 of 32 (15.6%)	Not reported
Clariti 1-Day	0 of 32 (0%)	0 of 32 (0%)	Not reported
MyDay	1 of 60 (1.7%)	0 of 60 (0%)	Not reported
1DAVTE	1 of 61 (1.6%)	0 of 61 (0%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 5 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
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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, EMEA study director

Alcon, A Novartis Division

Questions about this trial

What is this clinical trial studying?

A study testing Stenfilcon A contact lenses and Narafilcon A contact lenses 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 5 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 5 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?

High Contrast Time-Controlled Visual Acuity (TCVA) (VA Unit) Post-Exposure to Reduced Humidity at Day 10 (time frame: Day 10, 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 NCT02388763.

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 5 Dec 2016.