Refractive ErrorNCT03888482

Clinical Comparison of DDT2 Contact Lens and a Daily Disposable Contact Lens - Study 2

A study testing Verofilcon A contact lenses and Somofilcon A contact lenses in people with Refractive Error and Myopia, run by Alcon Research at 8 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 was to evaluate visual acuity at distance when wearing DDT2 contact lenses compared to Clariti contact lenses. Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Refractive Error, Myopia
What is being tested?: Verofilcon A contact lenses and Somofilcon A contact lenses
Type of treatment: Medical device
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 154 participants
Where: 8 sitesUnited States
Study dates: 26 Apr 2019to 28 Jun 2019
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 sign an Informed Consent Form that has been approved by an Institutional Review Board.
Willing and able to attend all scheduled study visits as required per protocol.
Current wearer of spherical soft contact lenses.

Who cannot join

Any ocular condition that contraindicates contact lens wear.
Previous or current habitual wearer of clariti® or DAILIES TOTAL1® contact lenses.

Trial locations and contacts

8 sites in 1 country.

City, postcode or hospital

8 sites in 1 country

United States8 sites

Alcon Investigative Site
Bloomington, Illinois, 61701
Alcon Investigative Site
Brentwood, Tennessee, 37027
Alcon Investigative Site
Jacksonville, Florida, 32256
Alcon Investigative Site
Maitland, Florida, 32751
Alcon Investigative Site
Memphis, Tennessee, 38111
Alcon Investigative Site
Orlando, Florida, 32803
Alcon Investigative Site
Powell, Ohio, 43065
Alcon Investigative Site
Warwick, Rhode Island, 02888

Other trials in United States

About this study

The purpose of this study was to evaluate visual acuity at distance when wearing DDT2 contact lenses compared to Clariti contact lenses.

Read the detailed description

Subjects were expected to attend 3 study visits and wear the DDT2 and Clariti study lenses in a crossover design for approximately 14 - 20 days (7 - 10 days for each product).

Conditions: Refractive Error, Myopia
Being tested: Verofilcon A contact lenses, Somofilcon A contact lenses
Keywords: Visual acuity, VA, Daily disposable contact lenses
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 daily disposable soft contact lenses
Somofilcon A contact lensesDevice
Also called clariti® 1 day, Clariti
Commercially available daily disposable soft contact lenses

Study groups in NCT03888482
Study group	Role	What they receive
DDT2, then Clariti	Other	Verofilcon A contact lenses worn first, with somofilcon A contact lenses worn second, as randomized. Each product was worn bilaterally (in both eyes) for 8 -1/+2 days in a daily disposable modality. Receives: Device: Verofilcon A contact lenses; Device: Somofilcon A contact lenses
Clariti, then DDT2	Other	Somofilcon A contact lenses worn first, with verofilcon A contact lenses worn second, as randomized. Each product was worn bilaterally (in both eyes) for 8 -1/+2 days in a daily disposable modality. Receives: Device: Verofilcon A contact lenses; Device: Somofilcon A contact lenses

What is being measured

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

Least Squares Mean Distance Visual Acuity With Study Lenses
Visual acuity was assessed and collected for each eye separately using logarithmic of the Minimum Angle of Resolution (logMAR) charts. A logMAR acuity of 0.0 corresponds to 20/20 Snellen acuity (normal visual acuity), with a negative value denoting better than 20/20 visual acuity.
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.

26 Apr 201928 Jun 2019

First posted25 Mar 2019
Study start26 Apr 2019
Primary completion28 Jun 2019
Study completion28 Jun 2019

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: 154 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT03888482
Sponsor's protocol ID: CLE383-C010
Status last verified: Jun 2020
First submitted: 22 Mar 2019
Last updated: 13 Jul 2020
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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BRIGHT-LIGHT: Studying Red Light Therapy for Severe Short-Sightedness or Short-Sightedness That Worsens Despite Standard Treatment
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All Refractive Error trials

Study at a glance

From the registry record, last updated by the sponsor on 13 Jul 2020. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Clinical Comparison of DDT2 Contact Lens and a Daily Disposable Contact Lens - Study 2
ClinicalTrials.gov ID: NCT03888482
Acronym / sponsor ID: CLE383-C010
Conditions: Refractive Error, Myopia
Keywords: Visual acuity, VA, Daily disposable contact lenses
Study type: Interventional
Recruitment status: Completed
Enrolment: 154 participants (actual)
Lead sponsor: Alcon ResearchIndustry (pharma, biotech, devices)
Study start: 26 Apr 2019 (actual)
Primary completion: 28 Jun 2019 (actual)
Study completion: 28 Jun 2019 (actual)
First posted: 25 Mar 2019 (actual)
Results: Posted 13 Jul 2020

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 was to evaluate visual acuity at distance when wearing DDT2 contact lenses compared to Clariti contact lenses.

Detailed description

Subjects were expected to attend 3 study visits and wear the DDT2 and Clariti study lenses in a crossover design for approximately 14 - 20 days (7 - 10 days for each product).

Study design

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

Arm	Type	Receives
DDT2, then Clariti	Other	Device: Verofilcon A contact lenses, Device: Somofilcon A contact lensesVerofilcon A contact lenses worn first, with somofilcon A contact lenses worn second, as randomized. Each product was worn bilaterally (in both eyes) for 8 -1/+2 days in a daily disposable modality.
Clariti, then DDT2	Other	Device: Verofilcon A contact lenses, Device: Somofilcon A contact lensesSomofilcon A contact lenses worn first, with verofilcon A contact lenses worn second, as randomized. Each product was worn bilaterally (in both eyes) for 8 -1/+2 days 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 (3 listed)

Able to understand and sign an Informed Consent Form that has been approved by an Institutional Review Board.
Willing and able to attend all scheduled study visits as required per protocol.
Current wearer of spherical soft contact lenses.

Key exclusion criteria (2 listed)

Any ocular condition that contraindicates contact lens wear.
Previous or current habitual wearer of clariti® or DAILIES TOTAL1® contact lenses.

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 daily disposable soft contact lenses	Device	Clariti, then DDT2, DDT2, then Clariti
Somofilcon A contact lensesAlso: clariti® 1 day, ClaritiCommercially available daily disposable soft contact lenses	Device	Clariti, then DDT2, DDT2, then Clariti

Primary outcome

Least Squares Mean Distance Visual Acuity With Study Lenses
Time frame: Day 8, each product
Visual acuity was assessed and collected for each eye separately using logarithmic of the Minimum Angle of Resolution (logMAR) charts. A logMAR acuity of 0.0 corresponds to 20/20 Snellen acuity (normal visual acuity), with a negative value denoting better than 20/20 visual acuity.

Results and safety

Results posted to the registry on 13 Jul 2020, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
DDT2, Then Clariti	76	76
Clariti, Then DDT2	75	75

Primary outcome: Least Squares Mean Distance Visual Acuity With Study Lenses

Time frame: Day 8, each product. Least squares mean (Standard Error). Unit: logMAR

Measure	DDT2 n = 151	Clariti n = 149
Value	-0.08 (0.006)	-0.08 (0.006)

DDT2 vs Clariti: Least Squares Mean Difference: 0.00, Mixed effects repeated measures model

Population analysed: Full analysis set (FAS): All randomized subjects/eyes with non-missing responses, who were exposed to any study lenses evaluated in this study, with the exception of the lenses used at Visit 1 for optimization and fitting.

Adverse events

Time frame: Adverse events were collected from time of consent to study exit (approximately 14-20 days). The safety analysis set included all subjects/eyes exposed to any study lenses evaluated in this study, with the exception of the lenses used at Visit 1 for the purpose of parameter optimization and fitting, as they were not intended for the assessment of safety.. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
DDT2 - Ocular	0 of 302 (0%)	0 of 302 (0%)	0 of 302
DDT2 - Systemic / Nonocular	0 of 151 (0%)	0 of 151 (0%)	0 of 151
Clariti - Ocular	0 of 298 (0%)	0 of 298 (0%)	0 of 298
Clariti - Systemic / Nonocular	0 of 149 (0%)	0 of 149 (0%)	0 of 149

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 13 Jul 2020.
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
Psilocybin for Amblyopia - Targeting Critical Periods in Humans
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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.

CDMA Project Lead, Vision Care study director

Alcon Research, LLC

8 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 and Somofilcon A contact lenses in people with Refractive Error and Myopia, run by Alcon Research at 8 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 3 inclusion and 2 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 13 Jul 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 8 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 13 Jul 2020). 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?

Least Squares Mean Distance Visual Acuity With Study Lenses (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 NCT03888482.

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 13 Jul 2020.