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.
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
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.
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
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 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.
- 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.
- 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)
Sponsor and investigators
- Lead sponsor
- Alcon Research
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Clinical Trial Lead, CRD Vision Care, Study director, Alcon Research, LLC
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