Refractive ErrorsNCT03567005

Clinical Validation of DACP Digital Design

A study testing Nelfilcon A digital contact lenses and Nelfilcon A contact lenses in people with Refractive Errors, run by Alcon Research at 5 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 visual performance of DAILIES® AquaComfort Plus® (DACP) Digital lenses by assessing distance visual acuity (VA) as compared to DACP sphere contact lenses after one week of wear. Read more about this study

Who is it for?: Ages 18 to 35 years
Conditions the study is for: Refractive Errors
What is being tested?: Nelfilcon A digital contact lenses and Nelfilcon A contact lenses
Type of treatment: Medical device
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 60 participants
Where: 5 sitesUnited States
Study dates: 25 Jun 2018to 26 Aug 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 to 35 years
All sexes
No healthy volunteers
Adult

Who may be able to join

Willing and able to sign an IRB/IEC approved Informed Consent form;
Current wearer of DACP spherical contact lenses (at least 2 months in current correction), with a minimum wearing time of 5 days per week and 8 hours per day;
Experiencing symptoms of eye strain from using technology;
Willing to wear study lenses each day;
Possess spectacles that provide a corrected visual acuity of 20/40 or better in both eyes (OU) and be willing to wear them (as needed);
Willing to NOT use rewetting/lubricating drops at any time during the study;
Currently using digital devices (computer, tablet, and/or smart phone) for a minimum of 5 days per week and 4 hours per day;
Willing to NOT use any near aid (e.g. reading glasses) at any time during the study.

Who cannot join

Conditions, use of medications, injury, or surgery, as specified in the protocol;
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);
Pregnant.

Trial locations and contacts

5 sites in 1 country.

City, postcode or hospital

5 sites in 1 country

United States5 sites

Alcon Investigative Site
Bloomington, Illinois, 61701
Alcon Investigative Site
Brentwood, Tennessee, 37027
Alcon Investigative Site
Memphis, Tennessee, 38104
Alcon Investigative Site
Memphis, Tennessee, 38111
Alcon Investigative Site
Powell, Ohio, 43065

Other trials in United States

About this study

Conditions: Refractive Errors
Being tested: Nelfilcon A digital contact lenses, Nelfilcon A 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.

Nelfilcon A digital contact lensesDevice
Also called DAILIES® AquaComfort Plus® Digital, DACP Digital
Silicone hydrogel digital contact lenses
Nelfilcon A contact lensesDevice
Also called DAILIES® AquaComfort Plus®, DACP
Silicone hydrogel spherical contact lenses

Study groups in NCT03567005
Study group	Role	What they receive
DACP Digital then DACP	Other	Nelfilcon A digital contact lenses worn first, followed by nelfilcon A contact lenses. Each product worn bilaterally (in both eyes) for 7 days in a daily disposable modality. Receives: Device: Nelfilcon A digital contact lenses; Device: Nelfilcon A contact lenses
DACP then DACP Digital	Other	Nelfilcon A contact lenses worn first, followed by nelfilcon A digital contact lenses. Each product worn bilaterally for 7 days in a daily disposable modality. Receives: Device: Nelfilcon A digital contact lenses; Device: Nelfilcon A contact lenses

What is being measured

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

Distance Visual Acuity (VA) (logMAR, OU)
VA was tested under photopic (well-lit) conditions using an Early Treatment Diabetic Retinopathy Study (ETDRS) chart positioned 6 meters from the subject. VA was collected bilaterally (OU) and measured in logMAR (logarithm of the minimum angle of resolution), with 0.1 logMAR increment corresponding to 5 letters, or 1 line, on the ETDRS chart. A lower numeric value represents better visual acuity.
Measured: Day 7, each product

Secondary outcomes (1)

Overall Vision
Subjective rating of overall vision on a scale of 1 (Poor) to 10 (Excellent). Both eyes contributed to the analysis.
Measured: Day 7, each product

Timeline

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

25 Jun 201826 Aug 2018

First posted25 Jun 2018
Study start25 Jun 2018
Primary completion26 Aug 2018
Study completion26 Aug 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 ErrorsStudies 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: Double blind
Who is masked: Participant, Investigator
Enrolment: 60 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT03567005
Sponsor's protocol ID: CLD523-C001
Status last verified: May 2019
First submitted: 13 Jun 2018
Last updated: 18 Jun 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 Errors trials

Study at a glance

From the registry record, last updated by the sponsor on 18 Jun 2019. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Clinical Validation of DACP Digital Design
ClinicalTrials.gov ID: NCT03567005
Acronym / sponsor ID: CLD523-C001
Conditions: Refractive Errors
Study type: Interventional
Recruitment status: Completed
Enrolment: 60 participants (actual)
Lead sponsor: Alcon ResearchIndustry (pharma, biotech, devices)
Study start: 25 Jun 2018 (actual)
Primary completion: 26 Aug 2018 (actual)
Study completion: 26 Aug 2018 (actual)
First posted: 25 Jun 2018 (actual)
Results: Posted 18 Jun 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: Crossover
Masking: Double blind (participant, investigator)
Number of arms: 2

Arm	Type	Receives
DACP Digital then DACP	Other	Device: Nelfilcon A digital contact lenses, Device: Nelfilcon A contact lensesNelfilcon A digital contact lenses worn first, followed by nelfilcon A contact lenses. Each product worn bilaterally (in both eyes) for 7 days in a daily disposable modality.
DACP then DACP Digital	Other	Device: Nelfilcon A digital contact lenses, Device: Nelfilcon A contact lensesNelfilcon A contact lenses worn first, followed by nelfilcon A digital contact lenses. Each product worn bilaterally for 7 days in a daily disposable modality.

Who may qualify

Ages: 18 to 35 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult

Key inclusion criteria (8 listed)

Willing and able to sign an IRB/IEC approved Informed Consent form;
Current wearer of DACP spherical contact lenses (at least 2 months in current correction), with a minimum wearing time of 5 days per week and 8 hours per day;
Experiencing symptoms of eye strain from using technology;
Willing to wear study lenses each day;
Possess spectacles that provide a corrected visual acuity of 20/40 or better in both eyes (OU) and be willing to wear them (as needed);

Key exclusion criteria (4 listed)

Conditions, use of medications, injury, or surgery, as specified in the protocol;
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);
Pregnant.

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
Nelfilcon A digital contact lensesAlso: DAILIES® AquaComfort Plus® Digital, DACP DigitalSilicone hydrogel digital contact lenses	Device	DACP Digital then DACP, DACP then DACP Digital
Nelfilcon A contact lensesAlso: DAILIES® AquaComfort Plus®, DACPSilicone hydrogel spherical contact lenses	Device	DACP Digital then DACP, DACP then DACP Digital

Primary outcome

Distance Visual Acuity (VA) (logMAR, OU)
Time frame: Day 7, each product
VA was tested under photopic (well-lit) conditions using an Early Treatment Diabetic Retinopathy Study (ETDRS) chart positioned 6 meters from the subject. VA was collected bilaterally (OU) and measured in logMAR (logarithm of the minimum angle of resolution), with 0.1 logMAR increment corresponding to 5 letters, or 1 line, on the ETDRS chart. A lower numeric value represents better visual acuity.

1 secondary outcome

Overall Vision
Time frame: Day 7, each product

Results and safety

Results posted to the registry on 18 Jun 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
DACP Digital Then DACP	29	29
DACP Then DACP Digital	31	31

Primary outcome: Distance Visual Acuity (VA) (logMAR, OU)

Time frame: Day 7, each product. Mean (Standard Deviation). Unit: logMAR

Measure	DACP Digital n = 60	DACP n = 58
Value	-0.11 (0.10)	-0.12 (0.09)

DACP Digital vs DACP: Least Squares Mean (LSM) Difference: 0.00

Population analysed: Full Analysis Set with non-missing response

1 secondary outcome is reported in the full results.

Adverse events

Time frame: Dispense through study completion, an average of 14 days. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
DACP Digital	0 of 60 (0%)	0 of 60 (0%)	0 of 60
DACP	0 of 60 (0%)	0 of 60 (0%)	0 of 60

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 18 Jun 2019.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Individual participant dataSharing planned: No

Related trials for Refractive Errors

Not yet recruitingObservational study
Corneal Biomechanics and Stromal Tissue Characteristics in Patients Undergoing SMILE
Myopia
Recruiting
Clareon TruPlus Study
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Enrolling by invitation
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Myopia
Not yet recruiting
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Astigmatism
RecruitingPhase 4
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Astigmatism

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

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

Questions about this trial

What is this clinical trial studying?

A study testing Nelfilcon A digital contact lenses and Nelfilcon A contact lenses in people with Refractive Errors, run by Alcon Research at 5 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 8 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 18 Jun 2019. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 5 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 18 Jun 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?

Distance Visual Acuity (VA) (logMAR, OU) (time frame: Day 7, 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 NCT03567005.

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 18 Jun 2019.