Refractive AmetropiaNCT04013789

Comparison of Two Daily Disposable Lenses

A study testing DACP FreshTech contact lenses and DACP contact lenses in people with Refractive Ametropia and Myopia, run by Alcon Research 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 was to compare the clinical performance of the new DAILIES® AquaComfort PLUS® FreshTech (DACP FreshTech) contact lenses to an already marketed daily disposable contact lens, DAILIES® AquaComfort PLUS® (DACP). Read more about this study

Who is it for?: Ages 18 to 35 years
Conditions the study is for: Refractive Ametropia, Myopia
What is being tested?: DACP FreshTech contact lenses and DACP contact lenses
Type of treatment: Medical device
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 79 participants
Where: 1 siteUnited States
Study dates: 27 Aug 2019to 22 Nov 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 to 35 years
All sexes
No healthy volunteers
Adult

Who may be able to join

At least 3 months of soft contact lens wearing experience;
Wears habitual lenses at least 5 days per week and at least 8 hours per day;
Uses digital devices (computer, tablet, and/or smart phone) for an average of 4 hours per day;
Experiences eye fatigue at least once per week attributable to digital device use with habitual lenses;
Is willing to NOT use rewetting/lubricating drops during the period of study product exposure;
Other protocol-specified inclusion criteria may apply.

Who cannot join

Routinely sleeps in contact lenses;
Known pregnancy at time of enrollment;
Binocular vision issues or issues of eye alignment;
Any eye infection, inflammation, disease or abnormality that contraindicates contact lens wear;
Use of medications as specified in the protocol;
Ocular surgery within the past 12 months;
Other protocol-specified exclusion criteria may apply.

Trial locations and contacts

1 site in 1 country.

United States1 site

Alcon Investigative Site
Bloomington, Indiana, 47405

Other trials in United States

About this study

Read the detailed description

Subjects attended 4 scheduled visits for an expected duration of participation of 3 weeks.

Conditions: Refractive Ametropia, Myopia
Being tested: DACP FreshTech contact lenses, DACP contact lenses
Keywords: eye strain, eye fatigue
Medical subject headings: Myopia, Asthenopia

What participants receive

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

DACP FreshTech contact lensesDevice
Also called DAILIES® AquaComfort PLUS® FreshTech
Nelfilcon A soft contact lenses with a modified lens design
DACP contact lensesDevice
Also called DAILIES® AquaComfort PLUS®
Nelfilcon A soft contact lenses

Study groups in NCT04013789
Study group	Role	What they receive
DACP FreshTech, then DACP	Other	DACP FreshTech contact lenses worn first, followed by DACP contact lenses, as randomized. Each product was worn in both eyes for approximately 8 hours per day for 1 week with a new pair of lenses worn each day. Receives: Device: DACP FreshTech contact lenses; Device: DACP contact lenses
DACP, then DACP FreshTech	Other	DACP contact lenses worn first, followed by DACP FreshTech contact lenses, as randomized.. Each product was worn in both eyes for approximately 8 hours per day, for 1 week with a new pair of lenses worn each day. Receives: Device: DACP FreshTech contact lenses; Device: DACP contact lenses

What is being measured

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

Mean Distance Visual Acuity (VA) With Study Lenses
VA was assessed at a distance of 4 meters using a letter chart and was measured in logarithm minimum angle of resolution (logMAR). A logMAR value of 0 equates to 20/20 Snellen visual acuity (normal distance eyesight), with a lower logMAR value indicating better visual acuity.
Measured: Week 1, each product

Timeline

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

27 Aug 201922 Nov 2019

First posted10 Jul 2019
Study start27 Aug 2019
Primary completion22 Nov 2019
Study completion22 Nov 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 AmetropiaStudies 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: 79 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT04013789
Sponsor's protocol ID: CLD523-P001
Status last verified: Nov 2020
First submitted: 8 Jul 2019
Last updated: 24 Nov 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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All Refractive Ametropia trials

Study at a glance

From the registry record, last updated by the sponsor on 24 Nov 2020. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Comparison of Two Daily Disposable Lenses
ClinicalTrials.gov ID: NCT04013789
Acronym / sponsor ID: CLD523-P001
Conditions: Refractive Ametropia, Myopia
Keywords: eye strain, eye fatigue
Study type: Interventional
Recruitment status: Completed
Enrolment: 79 participants (actual)
Lead sponsor: Alcon ResearchIndustry (pharma, biotech, devices)
Study start: 27 Aug 2019 (actual)
Primary completion: 22 Nov 2019 (actual)
Study completion: 22 Nov 2019 (actual)
First posted: 10 Jul 2019 (actual)
Results: Posted 10 Nov 2020

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Subjects attended 4 scheduled visits for an expected duration of participation of 3 weeks.

Study design

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

Arm	Type	Receives
DACP FreshTech, then DACP	Other	Device: DACP FreshTech contact lenses, Device: DACP contact lensesDACP FreshTech contact lenses worn first, followed by DACP contact lenses, as randomized. Each product was worn in both eyes for approximately 8 hours per day for 1 week with a new pair of lenses worn each day.
DACP, then DACP FreshTech	Other	Device: DACP FreshTech contact lenses, Device: DACP contact lensesDACP contact lenses worn first, followed by DACP FreshTech contact lenses, as randomized.. Each product was worn in both eyes for approximately 8 hours per day, for 1 week with a new pair of lenses worn each day.

Who may qualify

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

Key inclusion criteria (6 listed)

At least 3 months of soft contact lens wearing experience;
Wears habitual lenses at least 5 days per week and at least 8 hours per day;
Uses digital devices (computer, tablet, and/or smart phone) for an average of 4 hours per day;
Experiences eye fatigue at least once per week attributable to digital device use with habitual lenses;
Is willing to NOT use rewetting/lubricating drops during the period of study product exposure;

Key exclusion criteria (7 listed)

Routinely sleeps in contact lenses;
Known pregnancy at time of enrollment;
Binocular vision issues or issues of eye alignment;
Any eye infection, inflammation, disease or abnormality that contraindicates contact lens wear;
Use of medications as specified in the protocol;

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
DACP FreshTech contact lensesAlso: DAILIES® AquaComfort PLUS® FreshTechNelfilcon A soft contact lenses with a modified lens design	Device	DACP FreshTech, then DACP, DACP, then DACP FreshTech
DACP contact lensesAlso: DAILIES® AquaComfort PLUS®Nelfilcon A soft contact lenses	Device	DACP FreshTech, then DACP, DACP, then DACP FreshTech

Primary outcome

Mean Distance Visual Acuity (VA) With Study Lenses
Time frame: Week 1, each product
VA was assessed at a distance of 4 meters using a letter chart and was measured in logarithm minimum angle of resolution (logMAR). A logMAR value of 0 equates to 20/20 Snellen visual acuity (normal distance eyesight), with a lower logMAR value indicating better visual acuity.

Results and safety

Results posted to the registry on 10 Nov 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
DACP FreshTech, Then DACP	33	33
DACP, Then DACP FreshTech	34	34

Primary outcome: Mean Distance Visual Acuity (VA) With Study Lenses

Time frame: Week 1, each product. Mean (Standard Deviation). Unit: logMAR

Measure	DACP FreshTech n = 66	DACP n = 66
Value	-0.20 (0.06)	-0.22 (0.05)

DACP FreshTech vs DACP: Least Squares Mean Difference: 0.02, Mixed Effects Repeated Measures Model

Population analysed: Full Analysis Set: All randomized subjects (as randomized) who were exposed to any study lenses, not including the optimized habitual and trial fit lenses.

Adverse events

Time frame: Adverse events were collected from time of consent to study exit, approximately 3 weeks. The safety analysis set included all all randomized subjects (as treated) who were exposed to any study lenses, not including the optimized habitual and trial-fit lenses.. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
DACP FreshTech - Ocular	0 of 134 (0%)	0 of 134 (0%)	0 of 134
DACP FreshTech - Systemic / Nonocular	0 of 67 (0%)	0 of 67 (0%)	0 of 67
DACP - Ocular	0 of 132 (0%)	0 of 132 (0%)	0 of 132
DACP - Systemic / Nonocular	0 of 66 (0%)	0 of 66 (0%)	0 of 66

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 24 Nov 2020.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Individual participant dataSharing planned: No

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Comparison of Two Rotational Alignment Methods for Astigmatism Correction in SMILE Surgery
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Recruiting
The Impact of 'A Miss Is as Good as a Mile': Is Compensation Necessary for Minimal Ocular Deviation in Myopic Laser Surgery?
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Recruiting
Comparison of Low- Versus High-Level Angle Kappa Compensation Strategies in SMILE Using the VisuMax 800: A Randomized Clinical Trial
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A Study to Evaluate the Clinical Performance and Safety of UNICON Silicone Hydrogel Daily Disposable Soft Contact Lenses
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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.

Sr. Clinical Project Lead study director

Alcon Research

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

Questions about this trial

What is this clinical trial studying?

A study testing DACP FreshTech contact lenses and DACP contact lenses in people with Refractive Ametropia and Myopia, run by Alcon Research at 1 site 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 6 inclusion and 7 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 24 Nov 2020. 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 10 Nov 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?

Mean Distance Visual Acuity (VA) With Study Lenses (time frame: Week 1, 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 NCT04013789.

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 24 Nov 2020.