MyopiaNCT03305770
DD T2 Daily Disposable Registration Trial
A study testing verofilcon A contact lenses and delefilcon A contact lenses in people with Myopia and Refractive Errors, run by Alcon Research at 6 sites in United States.
Trial summary
The purpose of this study is to evaluate the performance of the investigational verofilcon A contact lens compared to the commercially available delefilcon A contact lens, by assessing visual acuity as the primary variable. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Myopia, Refractive Errors
- What is being tested?
- verofilcon A contact lenses and delefilcon A contact lenses
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 107 participants
- Where
- 6 sitesUnited States
- Study dates
- 12 Oct 2017to 21 Feb 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Successful wear of spherical soft contact lenses for distance correction in both eyes during the past 3 months for a minimum of 5 days per week and 8 hours per day.
- Best corrected VA 20/25 or better in each eye.
- Other protocol-specified inclusion criteria may apply.
Who cannot join
- Any current or prior wear experience with DT1 lenses.
- 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.
- Other protocol-specified exclusion criteria may apply.
Trial locations and contacts
6 sites in 1 country.
6 sites in 1 country
United States6 sites
Alcon Investigative Site
Bloomington, Illinois, 61701
Alcon Investigative Site
Brentwood, Tennessee, 37027
Alcon Investigative Site
Longwood, Florida, 32779
Alcon Investigative Site
Maitland, Florida, 32751
Alcon Investigative Site
Memphis, Tennessee, 38111
Alcon Investigative Site
San Diego, California, 92123
About this study
The purpose of this study is to evaluate the performance of the investigational verofilcon A contact lens compared to the commercially available delefilcon A contact lens, by assessing visual acuity as the primary variable.
Read the detailed description
Enrolled participants will be randomized (2:1) to receive either verofilcon A (test) contact lenses or delefilcon A (control) contact lenses for wear in both eyes and attend 7 office visits: Baseline, Dispense, 1-week follow-up, 2-week follow-up, 1-month follow-up, 2-month follow-up and 3-month follow-up/Exit.
- Conditions
- Myopia, Refractive Errors
- Being tested
- verofilcon A contact lenses, delefilcon A contact lenses
- Keywords
- soft contact lenses, vision, eyesight
- Medical subject headings
- Myopia, Refractive Errors
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
verofilcon A contact lensesDevice
Also called DD T2
Daily disposable soft contact lenses
delefilcon A contact lensesDevice
Also called DAILIES TOTAL1®, DT1
Daily disposable soft contact lenses
| Study group | Role | What they receive |
|---|---|---|
| DD T2 | Experimental | Verofilcon A contact lenses worn in both eyes for 3 months in a daily wear, daily disposable modality. A new pair of study lenses will be inserted each day and discarded at the end of the day. Receives: Device: verofilcon A contact lenses |
| DT 1 | Active comparator | Delefilcon A contact lenses worn in both eyes for 3 months in a daily wear, daily disposable modality. A new pair of study lenses will be inserted each day and discarded at the end of the day. Receives: Device: delefilcon A contact lenses |
What is being measured
The primary outcome is the main question the study is designed to answer.
Monocular Visual Acuity (VA) With Contact Lenses at Each Visit (Snellen)
VA was assessed for each eye individually using a Snellen chart at a distance of 4 meters. A 20/20 Snellen acuity is considered normal distance eyesight. No formal hypotheses were formulated; hence no inferential testing was performed.
Measured: Dispense, Week 1, Week 2, Month 1, Month 2, Month 3
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Oct 2017
- Study start12 Oct 2017
- Primary completion21 Feb 2018
- Study completion21 Feb 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 MyopiaStudies 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
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 107 participants (actual)
Sponsor and investigators
- Lead sponsor
- Alcon Research
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Alcon, a Novartis Division, Study director, Alcon, a Novartis Division
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03305770
- Sponsor's protocol ID
- CLE383-C005
- Status last verified
- Jan 2019
- First submitted
- 5 Oct 2017
- Last updated
- 22 Feb 2019
- Results posted
- Yes, on ClinicalTrials.gov
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Feb 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- DD T2 Daily Disposable Registration Trial
- ClinicalTrials.gov ID
- NCT03305770
- Acronym / sponsor ID
- CLE383-C005
- Conditions
- Myopia, Refractive Errors
- Keywords
- soft contact lenses, vision, eyesight
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 107 participants (actual)
- Lead sponsor
- Alcon ResearchIndustry (pharma, biotech, devices)
- Study start
- 12 Oct 2017 (actual)
- Primary completion
- 21 Feb 2018 (actual)
- Study completion
- 21 Feb 2018 (actual)
- First posted
- 10 Oct 2017 (actual)
- Results
- Posted 22 Feb 2019
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 evaluate the performance of the investigational verofilcon A contact lens compared to the commercially available delefilcon A contact lens, by assessing visual acuity as the primary variable.
Detailed description
Enrolled participants will be randomized (2:1) to receive either verofilcon A (test) contact lenses or delefilcon A (control) contact lenses for wear in both eyes and attend 7 office visits: Baseline, Dispense, 1-week follow-up, 2-week follow-up, 1-month follow-up, 2-month follow-up and 3-month follow-up/Exit.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| DD T2 | Experimental | Device: verofilcon A contact lensesVerofilcon A contact lenses worn in both eyes for 3 months in a daily wear, daily disposable modality. A new pair of study lenses will be inserted each day and discarded at the end of the day. |
| DT 1 | Active comparator | Device: delefilcon A contact lensesDelefilcon A contact lenses worn in both eyes for 3 months in a daily wear, daily disposable modality. A new pair of study lenses will be inserted each day and discarded at the end of the day. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Successful wear of spherical soft contact lenses for distance correction in both eyes during the past 3 months for a minimum of 5 days per week and 8 hours per day.
- Best corrected VA 20/25 or better in each eye.
- Other protocol-specified inclusion criteria may apply.
Key exclusion criteria (3 listed)
- Any current or prior wear experience with DT1 lenses.
- 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.
- Other protocol-specified exclusion criteria may apply.
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 |
|---|---|---|
| verofilcon A contact lensesAlso: DD T2Daily disposable soft contact lenses | Device | DD T2 |
| delefilcon A contact lensesAlso: DAILIES TOTAL1®, DT1Daily disposable soft contact lenses | Device | DT 1 |
Primary outcome
Monocular Visual Acuity (VA) With Contact Lenses at Each Visit (Snellen)
Time frame: Dispense, Week 1, Week 2, Month 1, Month 2, Month 3
VA was assessed for each eye individually using a Snellen chart at a distance of 4 meters. A 20/20 Snellen acuity is considered normal distance eyesight. No formal hypotheses were formulated; hence no inferential testing was performed.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Feb 2019.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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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.
Alcon, a Novartis Division study director
Alcon, a Novartis Division
6 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing verofilcon A contact lenses and delefilcon A contact lenses in people with Myopia and 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 22 Feb 2019. 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 22 Feb 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?
Monocular Visual Acuity (VA) With Contact Lenses at Each Visit (Snellen) (time frame: Dispense, Week 1, Week 2, Month 1, Month 2, Month 3). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 22 Feb 2019.