Refractive ErrorNCT02939170

Initial Performance of a Daily Disposable Contact Lens Featuring Molded Marks

A study testing Delefilcon A Multifocal Contact Lenses with Molded Mark and Delefilcon A Multifocal Contact Lenses in people with Refractive Error, run by Alcon, a Novartis Company at 1 site 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 impact of back surface molded marks (MM) applied to delefilcon A contact lenses as measured by the incidence of ocular discomfort device-related adverse events with DAILIES TOTAL1® Multifocal contact lenses with molded marks (DT1 MF MM) and current DAILIES TOTAL1®… 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?: Delefilcon A Multifocal Contact Lenses with Molded Mark and Delefilcon A Multifocal Contact Lenses
Type of treatment: Medical device
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 87 participants
Where: 1 siteUnited States
Study dates: 14 Nov 2016to 2 Dec 2016
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 an Informed Consent document;
Current wearer of commercial DAILIES TOTAL1® contact lenses;
Have spectacles in current prescription available to be worn in conjunction with the investigational product;
Manifest astigmatism less than or equal to 0.75 diopter (D) (at screening)
Best corrected distance visual acuity (BCVA) greater than or equal to 20/25 in each eye;
Other protocol-specified inclusion criteria may apply.

Who cannot join

Eye injury in either eye within 12 weeks prior to study enrollment;
Any anterior segment infection, inflammation, disease, or abnormality that contraindicates contact lens wear;
Any use of systemic or ocular medications for which contact lens wear could be contraindicated;
History of herpetic keratitis, refractive surgery or irregular cornea;
A pathologically dry eye that precludes contact lens wear;
Concurrent participation in a contact lens or contact lens care product clinical trial within the previous 30 days;
Monocular (only 1 eye with functional vision);
Other protocol-specified exclusion criteria may apply.

Trial locations and contacts

1 site in 1 country.

United States1 site

Contact Alcon Call Center for Trial Locations
Fort Worth, Texas, 76134

Other trials in United States

About this study

Conditions: Refractive Error
Being tested: Delefilcon A Multifocal Contact Lenses with Molded Mark, Delefilcon A Multifocal 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.

Delefilcon A Multifocal Contact Lenses with Molded MarkDevice
Delefilcon A Multifocal Contact LensesDevice
Also called DAILIES TOTAL1® Multifocal (DT1 MF)

Study groups in NCT02939170
Study group	Role	What they receive
DT1 MF MM	Experimental	Delefilcon A multifocal contact lenses with molded marks on back surface worn bilaterally (in both eyes) for 9 hours Receives: Device: Delefilcon A Multifocal Contact Lenses with Molded Mark
DT1 MF	Active comparator	Delefilcon A multifocal contact lenses worn bilaterally for 9 hours Receives: Device: Delefilcon A Multifocal Contact Lenses

What is being measured

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

Incidence of Ocular Discomfort Device-related Adverse Events (AE)
An AE was defined as any untoward medical occurrence, unintended disease or injury, or untoward clinical signs in subjects, users or other persons, whether or not related to the investigational medical device (test article). Ocular discomfort device-related AE was defined as an ocular AE classified as "Related" to study device and deemed to be related to ocular discomfort.
Measured: Day 1 at Hour 9

Secondary outcomes (2)

Ocular Staining
Assessed by the Investigator through slit-lamp examination and graded on a 5-point scale, where 0=none and 4=severe. Ocular staining was categorized by corneal staining, conjunctival staining, and limbal staining. Both eyes contributed to the analysis.
Measured: Day 1 at Hour 9
Limbal Hyperemia
Hyperemia (excess of blood) was assessed by the Investigator through slit-lamp examination and graded on a 5-point scale, where 0=none and 4=severe. Both eyes contributed to the analysis.
Measured: Day 1 at Hour 9

Timeline

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

14 Nov 20162 Dec 2016

First posted19 Oct 2016 (estimated)
Study start14 Nov 2016
Primary completion2 Dec 2016
Study completion2 Dec 2016

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.
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: Single blind
Who is masked: Participant
Enrolment: 87 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02939170
Sponsor's protocol ID: CLO870-C001
Status last verified: Dec 2017
First submitted: 18 Oct 2016
Last updated: 2 Jul 2018
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?

See locations

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All Refractive Error trials

Study at a glance

From the registry record, last updated by the sponsor on 2 Jul 2018. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Initial Performance of a Daily Disposable Contact Lens Featuring Molded Marks
ClinicalTrials.gov ID: NCT02939170
Acronym / sponsor ID: CLO870-C001
Conditions: Refractive Error
Study type: Interventional
Recruitment status: Completed
Enrolment: 87 participants (actual)
Lead sponsor: Alcon, a Novartis CompanyIndustry (pharma, biotech, devices)
Study start: 14 Nov 2016 (actual)
Primary completion: 2 Dec 2016 (actual)
Study completion: 2 Dec 2016 (actual)
First posted: 19 Oct 2016 (estimated)
Results: Posted 23 Jan 2018

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: Single blind (participant)
Number of arms: 2

Arm	Type	Receives
DT1 MF MM	Experimental	Device: Delefilcon A Multifocal Contact Lenses with Molded MarkDelefilcon A multifocal contact lenses with molded marks on back surface worn bilaterally (in both eyes) for 9 hours
DT1 MF	Active comparator	Device: Delefilcon A Multifocal Contact LensesDelefilcon A multifocal contact lenses worn bilaterally for 9 hours

Who may qualify

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

Key inclusion criteria (6 listed)

Must sign an Informed Consent document;
Current wearer of commercial DAILIES TOTAL1® contact lenses;
Have spectacles in current prescription available to be worn in conjunction with the investigational product;
Manifest astigmatism less than or equal to 0.75 diopter (D) (at screening)
Best corrected distance visual acuity (BCVA) greater than or equal to 20/25 in each eye;

Key exclusion criteria (8 listed)

Eye injury in either eye within 12 weeks prior to study enrollment;
Any anterior segment infection, inflammation, disease, or abnormality that contraindicates contact lens wear;
Any use of systemic or ocular medications for which contact lens wear could be contraindicated;
History of herpetic keratitis, refractive surgery or irregular cornea;
A pathologically dry eye that precludes contact lens wear;

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 Multifocal Contact Lenses with Molded Mark	Device	DT1 MF MM
Delefilcon A Multifocal Contact LensesAlso: DAILIES TOTAL1® Multifocal (DT1 MF)	Device	DT1 MF

Primary outcome

Incidence of Ocular Discomfort Device-related Adverse Events (AE)
Time frame: Day 1 at Hour 9
An AE was defined as any untoward medical occurrence, unintended disease or injury, or untoward clinical signs in subjects, users or other persons, whether or not related to the investigational medical device (test article). Ocular discomfort device-related AE was defined as an ocular AE classified as "Related" to study device and deemed to be related to ocular discomfort.

2 secondary outcomes

Ocular Staining
Time frame: Day 1 at Hour 9
Limbal Hyperemia
Time frame: Day 1 at Hour 9

Results and safety

Results posted to the registry on 23 Jan 2018, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
DT1 MF MM	40	40
DT1 MF	40	40

Primary outcome: Incidence of Ocular Discomfort Device-related Adverse Events (AE)

Time frame: Day 1 at Hour 9. Number. Unit: Events

Measure	DT1 MF MM n = 40	DT1 MF n = 40
Value	0	1

Population analysed: Safety Analysis Set

2 secondary outcomes are reported in the full results.

Adverse events

Time frame: Adverse events (AEs) were collected from time of consent for the duration of a subject's participation in the study (1 day). AEs are reported as pre-treatment and treatment-emergent.. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Pre-treatment	0 of 87 (0%)	0 of 87 (0%)	0 of 87
DT1 MF MM	0 of 40 (0%)	0 of 40 (0%)	0 of 40
DT1 MF	0 of 40 (0%)	0 of 40 (0%)	0 of 40

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 2 Jul 2018.
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
Hyperopia and Myopia

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 Manager, CTM study director

Alcon, A Novartis Division

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

Questions about this trial

What is this clinical trial studying?

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 6 inclusion and 8 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 2 Jul 2018. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site 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 23 Jan 2018). 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?

Incidence of Ocular Discomfort Device-related Adverse Events (AE) (time frame: Day 1 at Hour 9). 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 NCT02939170.

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 2 Jul 2018.