MyopiaNCT03628599

Two Daily Disposable Contact Lenses in Symptomatic Patients

A study testing Delefilcon A contact lenses and Senofilcon A contact lenses in people with Myopia, run by Alcon Research at 4 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 evaluate the performance of DAILIES TOTAL1® and ACUVUE OASYS® 1-DAY and with respect to visual acuity in a symptomatic study population of monthly or bi-weekly replacement lens wearers. Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Myopia
What is being tested?: Delefilcon A contact lenses and Senofilcon A contact lenses
Type of treatment: Medical device
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 39 participants
Where: 4 sitesUnited States
Study dates: 13 Aug 2018to 25 Sep 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 IRB-approved informed consent form;
Soft contact lens wearers in both eyes during the past 3 months;
Best-corrected visual acuity (BCVA) 20/25 or better in each eye;
Willing to wear study lenses at least 3 days per week and at least 8 hours per day;
Willing to stop wearing habitual contact lenses for the duration of study participation.

Who cannot join

Infection, inflammation, abnormality, condition, disease, surgery, or use of medications, as specified in the protocol;
Intolerance, hypersensitivity, or allergy to any component of the study products;
Wearing habitual contact lenses in an extended wear modality (routinely sleeping in lenses for at least 1 night per week) over the last 3 months prior to enrollment;
Monocular (only one eye with functional vision).

Trial locations and contacts

4 sites in 1 country.

United States4 sites

Alcon Investigative Site
Bloomington, Illinois, 61701
Alcon Investigative Site
Pittsburg, Kansas, 66762
Alcon Investigative Site
Powell, Ohio, 43065
Alcon Investigative Site
Warwick, Rhode Island, 02888

Other trials in United States

About this study

Conditions: Myopia
Being tested: Delefilcon A contact lenses, Senofilcon A contact lenses
Keywords: Symptomatic
Medical subject headings: Myopia

What participants receive

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

Delefilcon A contact lensesDevice
Also called DAILIES TOTAL1® (DT1)
Water Gradient silicon hydrogel daily disposable contact lenses
Senofilcon A contact lensesDevice
Also called ACUVUE OASYS® 1-DAY
Silicon hydrogel daily disposable contact lenses with HydraLuxe™ Technology

Study groups in NCT03628599
Study group	Role	What they receive
TOTAL1	Experimental	Delefilcon A contact lenses worn bilaterally (in both eyes) for 4 weeks in a daily disposable modality Receives: Device: Delefilcon A contact lenses
1-DAY	Active comparator	Senofilcon A contact lenses worn bilaterally for 4 weeks in a daily disposable modality Receives: Device: Senofilcon A contact lenses

What is being measured

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

Monocular Corrected Distance Visual Acuity (VA)
Monocular (each eye) corrected (with spectacles or other visual corrective devices) VA was performed under dimmed room illumination using an Early Treatment Diabetic Retinopathy Study (ETDRS) chart at distance. VA was reported in logMAR ("logarithm of the minimum angle of resolution"), with a lower logMAR indicating better visual acuity. No inferential hypotheses was planned for this endpoint.
Measured: Week 4

Timeline

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

13 Aug 201825 Sep 2018

First posted14 Aug 2018
Study start13 Aug 2018
Primary completion25 Sep 2018
Study completion25 Sep 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 MyopiaStudies 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: Parallel groups
Masking: None (open label)
Enrolment: 39 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT03628599
Sponsor's protocol ID: CLS312-P001
Status last verified: Jun 2019
First submitted: 9 Aug 2018
Last updated: 5 Jul 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 Myopia trials

Study at a glance

From the registry record, last updated by the sponsor on 5 Jul 2019. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Two Daily Disposable Contact Lenses in Symptomatic Patients
ClinicalTrials.gov ID: NCT03628599
Acronym / sponsor ID: CLS312-P001
Conditions: Myopia
Keywords: Symptomatic
Study type: Interventional
Recruitment status: Completed
Enrolment: 39 participants (actual)
Lead sponsor: Alcon ResearchIndustry (pharma, biotech, devices)
Study start: 13 Aug 2018 (actual)
Primary completion: 25 Sep 2018 (actual)
Study completion: 25 Sep 2018 (actual)
First posted: 14 Aug 2018 (actual)
Results: Posted 5 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: Parallel groups
Masking: None (open label)
Number of arms: 2

Arm	Type	Receives
TOTAL1	Experimental	Device: Delefilcon A contact lensesDelefilcon A contact lenses worn bilaterally (in both eyes) for 4 weeks in a daily disposable modality
1-DAY	Active comparator	Device: Senofilcon A contact lensesSenofilcon A contact lenses worn bilaterally for 4 weeks in a 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)

Able to understand and must sign an IRB-approved informed consent form;
Soft contact lens wearers in both eyes during the past 3 months;
Best-corrected visual acuity (BCVA) 20/25 or better in each eye;
Willing to wear study lenses at least 3 days per week and at least 8 hours per day;
Willing to stop wearing habitual contact lenses for the duration of study participation.

Key exclusion criteria (4 listed)

Infection, inflammation, abnormality, condition, disease, surgery, or use of medications, as specified in the protocol;
Intolerance, hypersensitivity, or allergy to any component of the study products;
Wearing habitual contact lenses in an extended wear modality (routinely sleeping in lenses for at least 1 night per week) over the last 3 months prior to enrollment;
Monocular (only one eye with functional vision).

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
Delefilcon A contact lensesAlso: DAILIES TOTAL1® (DT1)Water Gradient silicon hydrogel daily disposable contact lenses	Device	TOTAL1
Senofilcon A contact lensesAlso: ACUVUE OASYS® 1-DAYSilicon hydrogel daily disposable contact lenses with HydraLuxe™ Technology	Device	1-DAY

Primary outcome

Monocular Corrected Distance Visual Acuity (VA)
Time frame: Week 4
Monocular (each eye) corrected (with spectacles or other visual corrective devices) VA was performed under dimmed room illumination using an Early Treatment Diabetic Retinopathy Study (ETDRS) chart at distance. VA was reported in logMAR ("logarithm of the minimum angle of resolution"), with a lower logMAR indicating better visual acuity. No inferential hypotheses was planned for this endpoint.

Results and safety

Results posted to the registry on 5 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
TOTAL1	18	18
1-DAY	19	18

Primary outcome: Monocular Corrected Distance Visual Acuity (VA)

Time frame: Week 4. Mean (Standard Deviation). Unit: logMAR

Measure	TOTAL1 n = 18	1-DAY n = 18
Value	-0.01 (0.04)	-0.02 (0.05)

Population analysed: Safety Analysis Set with non-missing response

Adverse events

Time frame: Dispense through study completion, an average of 4 weeks. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
TOTAL1 Ocular - Right Eye	0 of 18 (0%)	0 of 18 (0%)	0 of 18
TOTAL1 Ocular - Left Eye	0 of 18 (0%)	0 of 18 (0%)	0 of 18
TOTAL1 Non-ocular	0 of 18 (0%)	0 of 18 (0%)	0 of 18
1-DAY Ocular - Right Eye	0 of 19 (0%)	1 of 19 (5.3%)	0 of 19
1-DAY Ocular - Left Eye	0 of 19 (0%)	1 of 19 (5.3%)	0 of 19
1-DAY Non-ocular	0 of 19 (0%)	1 of 19 (5.3%)	0 of 19

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 5 Jul 2019.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Individual participant dataSharing planned: No

Related trials for Myopia

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
Active, not recruiting
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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.

Alcon Research study director

Alcon Research

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

Questions about this trial

What is this clinical trial studying?

A study testing Delefilcon A contact lenses and Senofilcon A contact lenses in people with Myopia, run by Alcon Research at 4 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 5 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 4 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 5 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?

Monocular Corrected Distance Visual Acuity (VA) (time frame: Week 4). 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 NCT03628599.

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 Jul 2019.