Refractive ErrorsNCT03969290
Clinical Performance of Two Daily Disposable Contact Lenses - Study 1
A study testing Verofilcon A contact lenses and Etafilcon A contact lenses in people with Refractive Errors, run by Alcon Research at 1 site in Germany.
Trial summary
The purpose of this study is to evaluate end of day (EOD) visual acuity (VA) at distance when wearing Precision1™ contact lenses compared to Acuvue® Moist contact lenses. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Refractive Errors
- What is being tested?
- Verofilcon A contact lenses and Etafilcon A contact lenses
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 69 participants
- Where
- 1 siteGermany
- Study dates
- 5 Jun 2019to 5 Aug 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
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
- Able to understand and sign an approved Informed Consent form
- 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 of logMAR 0.10 or better in each eye
- Willing to discontinue artificial tears and rewetting drops during the study
- Able to wear contact lenses within the protocol-specified sphere power range
- Other protocol-specified inclusion criteria may apply.
Who cannot join
- Any anterior segment infection, inflammation, or abnormality or disease that contraindicates contact lens wear, as determined by the Investigator
- Any use of systemic or ocular medications for which contact lens wear could be contraindicated, as determined by the Investigator
- History of ocular or intraocular surgery, including refractive surgery, and/or irregular cornea
- 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
- Previous 3 years or current wearers of Acuvue Moist or DAILIES TOTAL1® contact lenses
- Other protocol-specified exclusion criteria may apply.
Trial locations and contacts
1 site in 1 country.
About this study
The purpose of this study is to evaluate end of day (EOD) visual acuity (VA) at distance when wearing Precision1™ contact lenses compared to Acuvue® Moist contact lenses.
Read the detailed description
The expected duration of subject participation in the study is 1-8 days, with 3 scheduled visits (Screening, Dispense, Exit).
- Conditions
- Refractive Errors
- Being tested
- Verofilcon A contact lenses, Etafilcon A contact lenses
- Keywords
- Contact lens, Vision correction, Visual acuity, Daily disposable contact lens
- Medical subject headings
- 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 Precision1™
Daily disposable silicone hydrogel contact lenses indicated for the optical correction of refractive ametropia (myopia and hyperopia)
Etafilcon A contact lensesDevice
Also called Acuvue® Moist
Daily disposable contact lenses indicated for the optical correction of refractive ametropia (myopia and hyperopia)
| Study group | Role | What they receive |
|---|---|---|
| Sequence 1 | Experimental | Verofilcon A contact lens in the right eye (OD), with etafilcon A contact lens in the left eye (OS), as randomized. Lenses will be worn for one day, approximately 8 hours. Receives: Device: Verofilcon A contact lenses; Device: Etafilcon A contact lenses |
| Sequence 2 | Active comparator | Etafilcon A contact lens in the right eye (OD), with verofilcon A contact lens in the left eye (OS), as randomized. Lenses will be worn for one day, approximately 8 hours. Receives: Device: Verofilcon A contact lenses; Device: Etafilcon A contact lenses |
What is being measured
The primary outcome is the main question the study is designed to answer.
End of day (EOD) visual acuity at distance
Visual acuity (VA) will be measured in "logarithm of the minimum angle of resolution" (logMAR). A lower logMAR value indicates better visual acuity.
Measured: Day 1, after 8 hours of wear
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 May 2019
- Study start5 Jun 2019
- Primary completion5 Aug 2019
- Study completion5 Aug 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Randomised
- Intervention model
- Parallel groups
- Model description
- Contralateral
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 69 participants (actual)
Sponsor and investigators
- Lead sponsor
- Alcon Research
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Alcon Research, Study director, Alcon Research
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03969290
- Sponsor's protocol ID
- CLE383-P001
- Status last verified
- Aug 2019
- First submitted
- 29 May 2019
- Last updated
- 22 Aug 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Aug 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Performance of Two Daily Disposable Contact Lenses - Study 1
- ClinicalTrials.gov ID
- NCT03969290
- Acronym / sponsor ID
- CLE383-P001
- Conditions
- Refractive Errors
- Keywords
- Contact lens, Vision correction, Visual acuity, Daily disposable contact lens
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 69 participants (actual)
- Lead sponsor
- Alcon ResearchIndustry (pharma, biotech, devices)
- Study start
- 5 Jun 2019 (actual)
- Primary completion
- 5 Aug 2019 (actual)
- Study completion
- 5 Aug 2019 (actual)
- First posted
- 31 May 2019 (actual)
- Results
- Not posted in the source record
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 end of day (EOD) visual acuity (VA) at distance when wearing Precision1™ contact lenses compared to Acuvue® Moist contact lenses.
Detailed description
The expected duration of subject participation in the study is 1-8 days, with 3 scheduled visits (Screening, Dispense, Exit).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
- Model description
- Contralateral
| Arm | Type | Receives |
|---|---|---|
| Sequence 1 | Experimental | Device: Verofilcon A contact lenses, Device: Etafilcon A contact lensesVerofilcon A contact lens in the right eye (OD), with etafilcon A contact lens in the left eye (OS), as randomized. Lenses will be worn for one day, approximately 8 hours. |
| Sequence 2 | Active comparator | Device: Verofilcon A contact lenses, Device: Etafilcon A contact lensesEtafilcon A contact lens in the right eye (OD), with verofilcon A contact lens in the left eye (OS), as randomized. Lenses will be worn for one day, approximately 8 hours. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Able to understand and sign an approved Informed Consent form
- 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 of logMAR 0.10 or better in each eye
- Willing to discontinue artificial tears and rewetting drops during the study
- Able to wear contact lenses within the protocol-specified sphere power range
Key exclusion criteria (6 listed)
- Any anterior segment infection, inflammation, or abnormality or disease that contraindicates contact lens wear, as determined by the Investigator
- Any use of systemic or ocular medications for which contact lens wear could be contraindicated, as determined by the Investigator
- History of ocular or intraocular surgery, including refractive surgery, and/or irregular cornea
- 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
- Previous 3 years or current wearers of Acuvue Moist or DAILIES TOTAL1® contact lenses
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: Precision1™Daily disposable silicone hydrogel contact lenses indicated for the optical correction of refractive ametropia (myopia and hyperopia) | Device | Sequence 1, Sequence 2 |
| Etafilcon A contact lensesAlso: Acuvue® MoistDaily disposable contact lenses indicated for the optical correction of refractive ametropia (myopia and hyperopia) | Device | Sequence 1, Sequence 2 |
Primary outcome
End of day (EOD) visual acuity at distance
Time frame: Day 1, after 8 hours of wear
Visual acuity (VA) will be measured in "logarithm of the minimum angle of resolution" (logMAR). A lower logMAR value indicates better visual acuity.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Aug 2019.
- 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 Research 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 Verofilcon A contact lenses and Etafilcon A contact lenses in people with Refractive Errors, run by Alcon Research at 1 site in Germany.
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 6 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 Aug 2019. 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 Germany. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
End of day (EOD) visual acuity at distance (time frame: Day 1, after 8 hours of wear). 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 Aug 2019.