AstigmatismNCT04464044
Clinical Performance of a Daily Disposable Toric Silicone Hydrogel Contact Lens
A study testing verofilcon A toric contact lenses in people with Astigmatism, run by Alcon Research at 1 site in United States.
Trial summary
The purpose of this study is to obtain on-eye clinical performance data to evaluate the stability of axis orientation of DDT2 toric contact lenses in the intended population. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Astigmatism
- What is being tested?
- verofilcon A toric contact lenses
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteUnited States
- Study dates
- 20 Jul 2020to 6 Aug 2020
- 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 informed consent form;
- Successful wear of spherical or toric soft contact lenses in both eyes, as specified in the protocol;
- Willing to NOT use rewetting/lubricating drops at any time during the study;
- Other protocol-specified inclusion criteria may apply.
Who cannot join
- Any eye condition that would contraindicate contact lens wear, as determined by the Investigator;
- History of eye surgery within the previous 12 months, as specified in the protocol;
- Current or history of dry eye in either eye that, in the opinion of the Investigator, would preclude contact lens wear;
- Other protocol-specified exclusion criteria may apply.
Trial locations and contacts
1 site in 1 country.
United States1 site
Contact Alcon Call Center for Trial Locations
Fort Worth, Texas, 76134
About this study
The purpose of this study is to obtain on-eye clinical performance data to evaluate the stability of axis orientation of DDT2 toric contact lenses in the intended population.
Read the detailed description
This is a single-visit, non-dispense study where subjects will be exposed to the test lenses for approximately 1 hour.
- Conditions
- Astigmatism
- Being tested
- verofilcon A toric contact lenses
- Keywords
- Toric contact lens, Daily disposable, Silicone hydrogel contact lens, Axis orientation, Astigmatism
- Medical subject headings
- Astigmatism
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
verofilcon A toric contact lensesDevice
Also called DDT2 Toric
Daily disposable toric soft contact lenses
| Study group | Role | What they receive |
|---|---|---|
| DDT2 Toric | Experimental | Verofilcon A toric contact lenses worn in both eyes Receives: Device: verofilcon A toric contact lenses |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percent of lenses with axis orientation within ±30° from the intended axis, 10 minutes after lens insertion
Axis orientation (orientation of the scribe mark) will be assessed by slit lamp examination and recorded as deviations from intended axis.
Measured: Day 1, 10 minutes after lens insertion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jul 2020
- Study start20 Jul 2020
- Primary completion6 Aug 2020
- Study completion6 Aug 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AstigmatismStudies 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
- Device feasibility
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Alcon Research
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Clinical Trial Lead, Vision Care, Study director, Alcon Research, LLC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04464044
- Sponsor's protocol ID
- CLA306-C003
- Status last verified
- Aug 2020
- First submitted
- 7 Jul 2020
- Last updated
- 19 Aug 2020
- Results posted
- No
- Data monitoring committee
- No
- 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 19 Aug 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Performance of a Daily Disposable Toric Silicone Hydrogel Contact Lens
- ClinicalTrials.gov ID
- NCT04464044
- Acronym / sponsor ID
- CLA306-C003
- Conditions
- Astigmatism
- Keywords
- Toric contact lens, Daily disposable, Silicone hydrogel contact lens, Axis orientation, Astigmatism
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Alcon ResearchIndustry (pharma, biotech, devices)
- Study start
- 20 Jul 2020 (actual)
- Primary completion
- 6 Aug 2020 (actual)
- Study completion
- 6 Aug 2020 (actual)
- First posted
- 9 Jul 2020 (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 obtain on-eye clinical performance data to evaluate the stability of axis orientation of DDT2 toric contact lenses in the intended population.
Detailed description
This is a single-visit, non-dispense study where subjects will be exposed to the test lenses for approximately 1 hour.
Study design
- Primary purpose
- Device feasibility
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| DDT2 Toric | Experimental | Device: verofilcon A toric contact lensesVerofilcon A toric contact lenses worn in both eyes |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Able to understand and sign an informed consent form;
- Successful wear of spherical or toric soft contact lenses in both eyes, as specified in the protocol;
- Willing to NOT use rewetting/lubricating drops at any time during the study;
- Other protocol-specified inclusion criteria may apply.
Key exclusion criteria (4 listed)
- Any eye condition that would contraindicate contact lens wear, as determined by the Investigator;
- History of eye surgery within the previous 12 months, as specified in the protocol;
- Current or history of dry eye in either eye that, in the opinion of the Investigator, would preclude contact lens wear;
- 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 toric contact lensesAlso: DDT2 ToricDaily disposable toric soft contact lenses | Device | DDT2 Toric |
Primary outcome
Percent of lenses with axis orientation within ±30° from the intended axis, 10 minutes after lens insertion
Time frame: Day 1, 10 minutes after lens insertion
Axis orientation (orientation of the scribe mark) will be assessed by slit lamp examination and recorded as deviations from intended axis.
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 19 Aug 2020.
- 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.
Clinical Trial Lead, Vision Care study director
Alcon Research, LLC
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 toric contact lenses in people with Astigmatism, 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 4 inclusion and 4 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 19 Aug 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?
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?
Percent of lenses with axis orientation within ±30° from the intended axis, 10 minutes after lens insertion (time frame: Day 1, 10 minutes after lens insertion). 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 19 Aug 2020.