Refractive ErrorNCT03349632

Clinical Comparison of 4 Daily Disposable Soft Contact Lenses

A study testing verofilcon A contact lenses, senofilcon A contact lenses and stenfilcon A contact lenses in people with Refractive Error, run by Alcon Research at 3 sites in United States.

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 obtain on-eye performance data to inform contact lens product development and to further evaluate product performance in the intended population. 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?: verofilcon A contact lenses, senofilcon A contact lenses and stenfilcon A contact lenses
Type of treatment: Medical device
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 68 participants
Where: 3 sitesUnited States
Study dates: 10 Jan 2018to 16 Feb 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

Able to understand and must sign an approved Informed Consent Form
Successfully wears daily disposable spherical soft contact lenses in both eyes for a minimum of 5 days per week and 8 hours per day during the past 3 months
Best Corrected Visual Acuity of 20/25 Snellen or better in each eye
Willing to stop wearing habitual contact lenses for the duration of study participation
Other protocol-defined inclusion criteria may apply

Who cannot join

Any eye condition, surgery, disease, or use of medication that contraindicates contact lens wear, as determined by the Investigator.
Routinely sleeps in habitual contact lenses
Currently wears Oasys 1-Day, MyDay, or Moist contact lenses
Other protocol-defined exclusion criteria may apply

Trial locations and contacts

3 sites in 1 country.

United States3 sites

Alcon Investigative Site
Johns Creek, Georgia, 30097
Alcon Investigative Site
Maitland, Florida, 32751
Alcon Investigative Site
Pensacola, Florida, 32503

Other trials in United States

About this study

The purpose of this study is to obtain on-eye performance data to inform contact lens product development and to further evaluate product performance in the intended population.

Read the detailed description

The expected duration of subject participation in the study is approximately 20 days with 3 scheduled visits. Each subject will evaluate the test contact lenses compared to 1 of 3 commercially available contact lenses.

Conditions: Refractive Error
Being tested: verofilcon A contact lenses, senofilcon A contact lenses, stenfilcon A contact lenses, etafilcon A contact lenses
Keywords: Contact lenses, Myopia, Near-sighted, Daily disposable
Medical subject headings: Refractive Errors, Myopia

What participants receive

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

verofilcon A contact lensesDevice
Also called DDT2
Investigational spherical silicone hydrogel contact lenses for daily disposable wear
senofilcon A contact lensesDevice
Also called ACUVUE OASYS® 1-Day with HydraLuxe™ Technology, Oasys 1-Day
Commercially available spherical silicone hydrogel contact lenses for daily disposable wear
stenfilcon A contact lensesDevice
Also called MyDay®, MyDay
Commercially available spherical silicone hydrogel contact lenses for daily disposable wear
etafilcon A contact lensesDevice
Also called 1-Day ACUVUE® MOIST, Moist
Commercially available spherical silicone hydrogel contact lenses for daily disposable wear

Study groups in NCT03349632
Study group	Role	What they receive
DD T2/Oasys 1-Day	Other	Verofilcon A contact lenses and senofilcon A contact lenses worn in both eyes, each product, for 1 week on a daily wear basis, as randomized Receives: Device: verofilcon A contact lenses; Device: senofilcon A contact lenses
DD T2/MyDay	Other	Verofilcon A contact lenses and stenfilcon A contact lenses worn in both eyes, each product, for 1 week on a daily disposable basis, as randomized Receives: Device: verofilcon A contact lenses; Device: stenfilcon A contact lenses
DD T2/Moist	Other	Verofilcon A contact lenses and etafilcon A contact lenses worn in both eyes, each product, for 1 week on a daily disposable basis, as randomized Receives: Device: verofilcon A contact lenses; Device: etafilcon A contact lenses

What is being measured

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

Overall Quality of Vision
Overall quality of vision was collected binocularly and rated on a 10-point scale with 1 = poor to 10 = excellent. Subjects were asked "Thinking back over the last week, please rate our study lenses. Rate eyes together." No formal hypotheses was conducted; hence no inferential testing was performed.
Measured: Day 8, each product

Timeline

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

10 Jan 201816 Feb 2018

First posted21 Nov 2017
Study start10 Jan 2018
Primary completion16 Feb 2018
Study completion16 Feb 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: 68 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT03349632
Sponsor's protocol ID: CLE383-C004
Status last verified: Jan 2019
First submitted: 17 Nov 2017
Last updated: 22 Feb 2019
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: Yes
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 22 Feb 2019. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Clinical Comparison of 4 Daily Disposable Soft Contact Lenses
ClinicalTrials.gov ID: NCT03349632
Acronym / sponsor ID: CLE383-C004
Conditions: Refractive Error
Keywords: Contact lenses, Myopia, Near-sighted, Daily disposable
Study type: Interventional
Recruitment status: Completed
Enrolment: 68 participants (actual)
Lead sponsor: Alcon ResearchIndustry (pharma, biotech, devices)
Study start: 10 Jan 2018 (actual)
Primary completion: 16 Feb 2018 (actual)
Study completion: 16 Feb 2018 (actual)
First posted: 21 Nov 2017 (actual)
Results: Posted 22 Feb 2019

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 obtain on-eye performance data to inform contact lens product development and to further evaluate product performance in the intended population.

Detailed description

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Crossover
Masking: Double blind (participant, investigator)
Number of arms: 3

Arm	Type	Receives
DD T2/Oasys 1-Day	Other	Device: verofilcon A contact lenses, Device: senofilcon A contact lensesVerofilcon A contact lenses and senofilcon A contact lenses worn in both eyes, each product, for 1 week on a daily wear basis, as randomized
DD T2/MyDay	Other	Device: verofilcon A contact lenses, Device: stenfilcon A contact lensesVerofilcon A contact lenses and stenfilcon A contact lenses worn in both eyes, each product, for 1 week on a daily disposable basis, as randomized
DD T2/Moist	Other	Device: verofilcon A contact lenses, Device: etafilcon A contact lensesVerofilcon A contact lenses and etafilcon A contact lenses worn in both eyes, each product, for 1 week on a daily disposable basis, as randomized

Who may qualify

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

Key inclusion criteria (5 listed)

Able to understand and must sign an approved Informed Consent Form
Successfully wears daily disposable spherical soft contact lenses in both eyes for a minimum of 5 days per week and 8 hours per day during the past 3 months
Best Corrected Visual Acuity of 20/25 Snellen or better in each eye
Willing to stop wearing habitual contact lenses for the duration of study participation
Other protocol-defined inclusion criteria may apply

Key exclusion criteria (4 listed)

Any eye condition, surgery, disease, or use of medication that contraindicates contact lens wear, as determined by the Investigator.
Routinely sleeps in habitual contact lenses
Currently wears Oasys 1-Day, MyDay, or Moist contact lenses
Other protocol-defined 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
verofilcon A contact lensesAlso: DDT2Investigational spherical silicone hydrogel contact lenses for daily disposable wear	Device	DD T2/Moist, DD T2/MyDay, DD T2/Oasys 1-Day
senofilcon A contact lensesAlso: ACUVUE OASYS® 1-Day with HydraLuxe™ Technology, Oasys 1-DayCommercially available spherical silicone hydrogel contact lenses for daily disposable wear	Device	DD T2/Oasys 1-Day
stenfilcon A contact lensesAlso: MyDay®, MyDayCommercially available spherical silicone hydrogel contact lenses for daily disposable wear	Device	DD T2/MyDay
etafilcon A contact lensesAlso: 1-Day ACUVUE® MOIST, MoistCommercially available spherical silicone hydrogel contact lenses for daily disposable wear	Device	DD T2/Moist

Primary outcome

Overall Quality of Vision
Time frame: Day 8, each product
Overall quality of vision was collected binocularly and rated on a 10-point scale with 1 = poor to 10 = excellent. Subjects were asked "Thinking back over the last week, please rate our study lenses. Rate eyes together." No formal hypotheses was conducted; hence no inferential testing was performed.

Results and safety

Results posted to the registry on 22 Feb 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
DD T2/Oasys 1-Day (Sequence 1)	11	11
Oasys 1-Day/DD T2 (Sequence 2)	11	11
DD T2/MyDay (Sequence 3)	11	11
MyDay/DD T2 (Sequence 4)	11	11
DD T2/Moist (Sequence 5)	11	11
Moist/DD T2 (Sequence 6)	11	11

Primary outcome: Overall Quality of Vision

Time frame: Day 8, each product. Mean (Standard Deviation). Unit: units on a scale

Measure	DD T2 (Sequence 1 and 2) n = 22	Oasys 1-Day (Sequence 1 and 2) n = 22	DD T2 (Sequence 3 and 4) n = 22	MyDay (Sequence 3 and 4) n = 22	DD T2 (Sequence 5 and 6) n = 22	Moist (Sequence 5 and 6) n = 22
Value	8.5 (1.4)	9.2 (1.3)	8.8 (1.8)	9.4 (0.8)	9.2 (1.1)	8.8 (1.7)

Population analysed: Safety Analysis Set

Adverse events

Time frame: Dispense through study completion, an average of 2 weeks. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
DD T2 (Sequence 1 and 2)	0 of 22 (0%)	0 of 22 (0%)	0 of 22
Oasys 1- Day (Sequence 1 and 2)	0 of 22 (0%)	0 of 22 (0%)	0 of 22
DD T2 (Sequence 3 and 4)	0 of 22 (0%)	0 of 22 (0%)	0 of 22
MyDay (Sequence 3 and 4)	0 of 22 (0%)	0 of 22 (0%)	0 of 22
DD T2 (Sequence 5 and 6)	0 of 22 (0%)	0 of 22 (0%)	0 of 22
Moist (Sequence 5 and 6)	0 of 22 (0%)	0 of 22 (0%)	0 of 22

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 22 Feb 2019.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Individual participant dataSharing planned: No

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Clinical Performance and Outcomes After Toric Lens Transition
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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.

The record lists no contact. Use the official record to reach the sponsor.

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

Questions about this trial

What is this clinical trial studying?

A study testing verofilcon A contact lenses, senofilcon A contact lenses and stenfilcon A contact lenses in people with Refractive Error, run by Alcon Research at 3 sites in United States.

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 4 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 22 Feb 2019. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 3 sites in United States. 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 22 Feb 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?

Overall Quality of Vision (time frame: Day 8, 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 NCT03349632.

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 22 Feb 2019.