Refractive ErrorNCT02871375

Clinical Assessment of DAILIES TOTAL1® (DT1) Multifocal

A study testing Delefilcon A multifocal contact lenses and Habitual multifocal contact lenses in people with Refractive Error, run by Alcon, a Novartis Company.

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 DAILIES TOTAL1® Multifocal (DTl MF) contact lenses in current multifocal contact lens wearers with symptoms of end of day discomfort compared to their habitual multifocal contact lens correction. Read more about this study

Who is it for?: Ages 40 to 65 years
Conditions the study is for: Refractive Error
What is being tested?: Delefilcon A multifocal contact lenses and Habitual multifocal contact lenses
Type of treatment: Medical device
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 170 participants
Where: No sites listed yet
Study dates: 30 Aug 2016to 14 Nov 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 40 to 65 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Must sign an informed consent document;
Current daily wearer of soft multifocal contact lenses for at least 6 months with symptoms of contact lens discomfort as defined by the prescreening Eligibility Questionnaire;
Requires a near spectacle add of +0.50 to +2.50 diopters (D) (inclusive);
Requires lenses within the power range of study lenses to be fitted;
Best corrected VA (BCVA) of 20/30 (0.2 logarithmic minimum angle of resolution [logMAR]) or better in each eye at distance;
Willing to wear study lenses for a minimum of 5 days per week, 6 hours per day, and attend all study visits;
Other protocol-defined inclusion criteria may apply.

Who cannot join

Any eye condition that contraindicates wearing contact lenses as determined by the Investigator;
Any use of medications for which contact lens wear could be contraindicated, as determined by the Investigator;
Monocular (only one eye functional) or fit with only 1 lens;
Fitted with monovision;
Prior refractive surgery (e.g., laser vision correction, photorefractive keratectomy, etc.);
History of herpetic keratitis, ocular surgery, or irregular cornea;
Currently wearing DT1 MF contact lenses;
Other protocol-defined exclusion criteria may apply.

About this study

Official title: DAILIES TOTAL1® Multifocal Clinical Assessment in Challenging Patients

Conditions: Refractive Error
Being tested: Delefilcon A multifocal contact lenses, Habitual multifocal contact lenses
Keywords: myopia, presbyopia
Medical subject headings: Refractive Errors, Myopia, Presbyopia

What participants receive

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

Delefilcon A multifocal contact lensesDevice
Also called DAILIES TOTAL1® multifocal
Multifocal contact lenses worn in a daily wear, daily disposable modality (new pair of lenses each morning)
Habitual multifocal contact lensesDevice
Multifocal contact lenses worn per subject's habitual prescription and habitual daily wear modality

Study groups in NCT02871375
Study group	Role	What they receive
DT1 MF, then Habitual	Other	Delefilcon A multifocal contact lenses in Period 1, followed by subject's habitual multifocal contact lenses in Period 2. Each product worn bilaterally (in both eyes) for 14 ± 3 days. Receives: Device: Delefilcon A multifocal contact lenses; Device: Habitual multifocal contact lenses
Habitual, then DT1 MF	Other	Subject's habitual multifocal contact lenses in Period 1, followed by delefilcon A multifocal contact lenses in Period 2. Each product worn bilaterally (in both eyes) for 14 ± 3 days. Receives: Device: Delefilcon A multifocal contact lenses; Device: Habitual multifocal contact lenses

What is being measured

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

Binocular High Contrast/High Illumination (HC/HI) Visual Acuity (VA) at Intermediate Distance (80 cm)
Visual Acuity (clarity or sharpness of vision) was measured at high contrast level. HC/HI VA was assessed binocularly (both eyes together) at 80 centimeters using an Early Treatment Diabetic Retinopathy Study (ETDRS) chart and measured in logarithm of the minimum angle of resolution (logMAR). A lower logMAR value indicates better visual acuity.
Measured: Day 14, each product

Secondary outcomes (1)

Contact Lens Dry Eye Questionnaire-8 (CLDEQ-8) Score
The abbreviated CLDEQ-8 is an 8-item questionnaire used to assess comfort and dryness. Total CLDEQ-8 score ranged from 0 to 37, where a lower score represented less symptomology.
Measured: Day 14, each product

Timeline

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

30 Aug 201614 Nov 2016

First posted18 Aug 2016 (estimated)
Study start30 Aug 2016
Primary completion14 Nov 2016
Study completion14 Nov 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: Crossover
Masking: Single blind
Who is masked: Outcomes assessor
Enrolment: 170 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02871375
Sponsor's protocol ID: CLE914-P001
Status last verified: Oct 2017
First submitted: 15 Aug 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?

Official record

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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: DAILIES TOTAL1® Multifocal Clinical Assessment in Challenging Patients
ClinicalTrials.gov ID: NCT02871375
Acronym / sponsor ID: CLE914-P001
Conditions: Refractive Error
Keywords: myopia, presbyopia
Study type: Interventional
Recruitment status: Completed
Enrolment: 170 participants (actual)
Lead sponsor: Alcon, a Novartis CompanyIndustry (pharma, biotech, devices)
Study start: 30 Aug 2016 (actual)
Primary completion: 14 Nov 2016 (actual)
Study completion: 14 Nov 2016 (actual)
First posted: 18 Aug 2016 (estimated)
Results: Posted 24 Nov 2017

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: Crossover
Masking: Single blind (outcomes assessor)
Number of arms: 2

Arm	Type	Receives
DT1 MF, then Habitual	Other	Device: Delefilcon A multifocal contact lenses, Device: Habitual multifocal contact lensesDelefilcon A multifocal contact lenses in Period 1, followed by subject's habitual multifocal contact lenses in Period 2. Each product worn bilaterally (in both eyes) for 14 ± 3 days.
Habitual, then DT1 MF	Other	Device: Delefilcon A multifocal contact lenses, Device: Habitual multifocal contact lensesSubject's habitual multifocal contact lenses in Period 1, followed by delefilcon A multifocal contact lenses in Period 2. Each product worn bilaterally (in both eyes) for 14 ± 3 days.

Who may qualify

Ages: 40 to 65 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (7 listed)

Must sign an informed consent document;
Current daily wearer of soft multifocal contact lenses for at least 6 months with symptoms of contact lens discomfort as defined by the prescreening Eligibility Questionnaire;
Requires a near spectacle add of +0.50 to +2.50 diopters (D) (inclusive);
Requires lenses within the power range of study lenses to be fitted;
Best corrected VA (BCVA) of 20/30 (0.2 logarithmic minimum angle of resolution [logMAR]) or better in each eye at distance;

Key exclusion criteria (8 listed)

Any eye condition that contraindicates wearing contact lenses as determined by the Investigator;
Any use of medications for which contact lens wear could be contraindicated, as determined by the Investigator;
Monocular (only one eye functional) or fit with only 1 lens;
Fitted with monovision;
Prior refractive surgery (e.g., laser vision correction, photorefractive keratectomy, etc.);

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 lensesAlso: DAILIES TOTAL1® multifocalMultifocal contact lenses worn in a daily wear, daily disposable modality (new pair of lenses each morning)	Device	DT1 MF, then Habitual, Habitual, then DT1 MF
Habitual multifocal contact lensesMultifocal contact lenses worn per subject's habitual prescription and habitual daily wear modality	Device	DT1 MF, then Habitual, Habitual, then DT1 MF

Primary outcome

Binocular High Contrast/High Illumination (HC/HI) Visual Acuity (VA) at Intermediate Distance (80 cm)
Time frame: Day 14, each product
Visual Acuity (clarity or sharpness of vision) was measured at high contrast level. HC/HI VA was assessed binocularly (both eyes together) at 80 centimeters using an Early Treatment Diabetic Retinopathy Study (ETDRS) chart and measured in logarithm of the minimum angle of resolution (logMAR). A lower logMAR value indicates better visual acuity.

1 secondary outcome

Contact Lens Dry Eye Questionnaire-8 (CLDEQ-8) Score
Time frame: Day 14, each product

Results and safety

Results posted to the registry on 24 Nov 2017, 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 / Habitual MF	89	89
Habitual MF / DT1 MF	77	76

Primary outcome: Binocular High Contrast/High Illumination (HC/HI) Visual Acuity (VA) at Intermediate Distance (80 cm)

Time frame: Day 14, each product. Mean (Standard Deviation). Unit: logMAR

Measure	DT1 MF n = 152	Habitual MF n = 153
Value	-0.07 (0.10)	-0.09 (0.10)

Population analysed: Full Analysis Set. Number Analyzed is the number of subjects with non-missing responses.

1 secondary outcome is 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 (up to 44 days). 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 170 (0%)	0 of 170 (0%)	0 of 170
DT1 MF	0 of 165 (0%)	0 of 165 (0%)	0 of 165
Habitual MF	0 of 166 (0%)	0 of 166 (0%)	0 of 166

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.

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Recruiting
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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
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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 Project Manager, PLS study director

Alcon, A Novartis Division

Questions about this trial

What is this clinical trial studying?

A study testing Delefilcon A multifocal contact lenses and Habitual multifocal contact lenses in people with Refractive Error, run by Alcon, a Novartis Company.

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 7 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.

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 24 Nov 2017). 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?

Binocular High Contrast/High Illumination (HC/HI) Visual Acuity (VA) at Intermediate Distance (80 cm) (time frame: Day 14, 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 NCT02871375.

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.