Refractive ErrorsNCT06044948

Clinical Assessment of a Daily Disposable Soft Silicone Hydrogel Contact Lens

A study testing Delefilcon A contact lenses in people with Refractive Errors, run by Alcon Research at 6 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 assess the clinical performance of DAILIES TOTAL1® spherical soft contact lenses over approximately 1 week of daily wear. Read more about this study

Who is it for?: Ages 18 years and olderHealthy volunteers can take part
Conditions the study is for: Refractive Errors
What is being tested?: Delefilcon A contact lenses
Type of treatment: Medical device
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 97 participants
Where: 6 sitesUnited States
Study dates: 13 Oct 2023to 8 Nov 2023
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
Healthy volunteers accepted
Adult, Older adult

Who may be able to join

Current wearer of commercial spherical soft contact lenses in both eyes with at least 3 months of wearing experience, with a minimum wearing time of 5 days per week and 10 hours per day;
Manifest cylinder less than or equal to 0.75 diopter (D) in each eye;
Best corrected distance visual acuity better than or equal to 20/25 (Snellen) in each eye.

Who cannot join

Current or prior habitual DAILIES TOTAL1 soft contact lens wear in the past 3 months prior to consent;
Monovision contact lens wear;
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.

Trial locations and contacts

6 sites in 1 country.

City, postcode or hospital

6 sites in 1 country

United States6 sites

The Eye Doctors, Inc.
Eden Prairie, Minnesota, 55344
Oculus Research, Inc.
Garner, North Carolina, 27529
ProCare Vision Center
Granville, Ohio, 43023
Optometry Group, PLLC
Memphis, Tennessee, 38111
Tallahassee Eye Center
Tallahassee, Florida, 32308
Wyomissing Optometric Center
Wyomissing, Pennsylvania, 19610

Other trials in United States

About this study

The purpose of this study is to assess the clinical performance of DAILIES TOTAL1® spherical soft contact lenses over approximately 1 week of daily wear.

Read the detailed description

Subjects will be expected to attend 2 visits (Visit 1 Screen/Baseline/ Dispense; and Visit 2 Week 1 Follow-up/ Exit). The total duration of a subject's participation in the study as well as exposure to the contact lenses will be approximately 1 week (6-8 days of contact lens wear).

Conditions: Refractive Errors
Being tested: Delefilcon A contact lenses
Keywords: 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 contact lensesDevice
Also called DAILIES TOTAL1
Daily disposable, silicone hydrogel spherical contact lenses

Study groups in NCT06044948
Study group	Role	What they receive
DAILIES TOTAL1	Experimental	Delefilcon A contact lenses worn in both eyes for the typical number of hours the subject wears his/her habitual contact lenses. The lenses will be worn in a daily disposable manner. Receives: Device: Delefilcon A contact lenses

What is being measured

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

Distance VA With Study Lenses at Week 1
Visual acuity (VA) was measured for each eye individually with study lenses on eye using letter charts. VA was recorded in Snellen where 20/20 represents normal distance eyesight and 20/15 represents better than normal eyesight. No hypothesis testing was prespecified for this endpoint.
Measured: Week 1

Timeline

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

13 Oct 20238 Nov 2023

First posted21 Sep 2023
Study start13 Oct 2023
Primary completion8 Nov 2023
Study completion8 Nov 2023

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.
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: Not applicable
Intervention model: Single group
Masking: None (open label)
Enrolment: 97 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT06044948
Sponsor's protocol ID: CLU484-P003
Status last verified: Oct 2024
First submitted: 13 Sep 2023
Last updated: 20 Nov 2024
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 20 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Clinical Assessment of a Daily Disposable Soft Silicone Hydrogel Contact Lens
ClinicalTrials.gov ID: NCT06044948
Acronym / sponsor ID: CLU484-P003
Conditions: Refractive Errors
Keywords: Contact Lenses
Study type: Interventional
Recruitment status: Completed
Enrolment: 97 participants (actual)
Lead sponsor: Alcon ResearchIndustry (pharma, biotech, devices)
Study start: 13 Oct 2023 (actual)
Primary completion: 8 Nov 2023 (actual)
Study completion: 8 Nov 2023 (actual)
First posted: 21 Sep 2023 (actual)
Results: Posted 20 Nov 2024

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 is to assess the clinical performance of DAILIES TOTAL1® spherical soft contact lenses over approximately 1 week of daily wear.

Detailed description

Study design

Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Number of arms: 1

Arm	Type	Receives
DAILIES TOTAL1	Experimental	Device: Delefilcon A contact lensesDelefilcon A contact lenses worn in both eyes for the typical number of hours the subject wears his/her habitual contact lenses. The lenses will be worn in a daily disposable manner.

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Accepted
Age groups: Adult, Older adult

Key inclusion criteria (3 listed)

Current wearer of commercial spherical soft contact lenses in both eyes with at least 3 months of wearing experience, with a minimum wearing time of 5 days per week and 10 hours per day;
Manifest cylinder less than or equal to 0.75 diopter (D) in each eye;
Best corrected distance visual acuity better than or equal to 20/25 (Snellen) in each eye.

Key exclusion criteria (3 listed)

Current or prior habitual DAILIES TOTAL1 soft contact lens wear in the past 3 months prior to consent;
Monovision contact lens wear;
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.

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 contact lensesAlso: DAILIES TOTAL1Daily disposable, silicone hydrogel spherical contact lenses	Device	DAILIES TOTAL1

Primary outcome

Distance VA With Study Lenses at Week 1
Time frame: Week 1
Visual acuity (VA) was measured for each eye individually with study lenses on eye using letter charts. VA was recorded in Snellen where 20/20 represents normal distance eyesight and 20/15 represents better than normal eyesight. No hypothesis testing was prespecified for this endpoint.

Results and safety

Results posted to the registry on 20 Nov 2024, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
DAILIES TOTAL1	96	96

Primary outcome: Distance VA With Study Lenses at Week 1

Time frame: Week 1. Number. Unit: eyes

Measure	DAILIES TOTAL1 n = 96
20/15	95
20/20	92
20/25	5

Population analysed: The safety analysis set included all subjects/eyes exposed to DAILIES TOTAL1 lenses evaluated in this study.

Adverse events

Time frame: Adverse Events (AEs) were collected from time of consent to study exit, up to approximately 6 to 8 days of contact lens wear.. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Pretreatment	0 of 96 (0%)	0 of 96 (0%)	0 of 96
DAILIES TOTAL1 Ocular	0 of 192 (0%)	0 of 192 (0%)	0 of 192
DAILIES TOTAL1 Nonocular	0 of 96 (0%)	0 of 96 (0%)	0 of 96

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 20 Nov 2024.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Individual participant dataSharing planned: No

Related trials for Refractive Errors

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
Amblyopia
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.

Clinical Trial Lead, CRD Vision Care study director

Alcon Research, LLC

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

Questions about this trial

What is this clinical trial studying?

A study testing Delefilcon A contact lenses in people with Refractive Errors, run by Alcon Research at 6 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 3 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 20 Nov 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 6 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 20 Nov 2024). 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 VA With Study Lenses at Week 1 (time frame: Week 1). 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 NCT06044948.

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 20 Nov 2024.