AstigmatismNCT06098937
Kalifilcon A Toric Compared to Commercially Available Lenses
A study testing Kalifilcon Toric Lens, Total1 for Astigmatism and Precision1 for Astigmatism in people with Astigmatism, run by Bausch & Lomb Incorporated at 1 site in United States.
Trial summary
Approximately thirty contact lens adapted subjects will be enrolled in this feasibility, bilateral, randomized, double masked (subject and investigator masked), repeated measures insertion study. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Astigmatism
- What is being tested?
- Kalifilcon Toric Lens, Total1 for Astigmatism and Precision1 for Astigmatism
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteUnited States
- Study dates
- 5 Sep 2023to 27 Sep 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
- Be 18 years or older on the date the Informed Consent Form (ICF) is signed and have capacity to read, understand and provide written voluntary informed consent.
- Have physiologically normal anterior segments not exhibiting clinically significant biomicroscopy findings.
- Have no active ocular disease or allergic conjunctivitis.
- Not be using any topical ocular medications.
- Be willing and able to follow instructions.
- Have signed a statement of informed consent.
Who cannot join
- Participating in a conflicting study in the opinion of the Investigator.
- Considered by the Investigator to not be a suitable candidate for participation
Trial locations and contacts
1 site in 1 country.
United States1 site
Bausch & Lomb, Incorporated
Rochester, New York, 14609
About this study
Official title: Orientation Characteristics of Kalifilcon A Daily Disposable Toric Contact Lenses Compared to Commercially Available Daily Disposable Toric Contact Lenses
Approximately thirty contact lens adapted subjects will be enrolled in this feasibility, bilateral, randomized, double masked (subject and investigator masked), repeated measures insertion study.
Read the detailed description
Approximately 30 soft toric contact lens adapted subjects will be enrolled in this feasibility, bilateral, randomized, double masked (subject and investigator masked), repeated measures insertion study. All subjects will be seen for a Screening/Dispensing Visit at which informed consent will be obtained and eligibility will be assessed. If study eligibility is met, subjects will have lenses inserted in random, successive order. Subjects will be receiving each of the study lens types once, in a randomized order. The subject will wear each of the study contact lenses for approximately 10 minutes.
- Conditions
- Astigmatism
- Being tested
- Kalifilcon Toric Lens, Total1 for Astigmatism, Precision1 for Astigmatism, MyDay Toric
- Keywords
- Contact Lens
- Medical subject headings
- Astigmatism
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Kalifilcon Toric LensDevice
Kalifilcon A Daily Disposable Toric for Ametropia
Total1 for AstigmatismDevice
Total1 for Astigmatism
Precision1 for AstigmatismDevice
Precision1 for Astigmatism
MyDay ToricDevice
MyDay Toric
| Study group | Role | What they receive |
|---|---|---|
| Kalifilcon A Daily Disposable Toric | Experimental | Kalifilcon A Daily Disposable Toric Receives: Device: Kalifilcon Toric Lens |
| Total1 for Astigmatism | Active comparator | Total1 for Astigmatism Receives: Device: Total1 for Astigmatism |
| Precision1 for Astigmatism | Active comparator | Precision1 for Astigmatism Receives: Device: Precision1 for Astigmatism |
| MyDay Toric | Active comparator | MyDay Toric Receives: Device: MyDay Toric |
What is being measured
The primary outcome is the main question the study is designed to answer.
Primary Gaze Orientation for 5 Minutes
Primary gaze orientation is measured in degrees using a slit lamp and reticule.
Measured: 5 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 posted25 Oct 2023
- Study start5 Sep 2023
- Primary completion27 Sep 2023
- Study completion27 Sep 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 AstigmatismStudies 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
- Crossover
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bausch & Lomb Incorporated
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06098937
- Sponsor's protocol ID
- ROC-23-007
- Status last verified
- Dec 2024
- First submitted
- 29 Sep 2023
- Last updated
- 10 Dec 2024
- Results posted
- Yes, on ClinicalTrials.gov
- 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 10 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Orientation Characteristics of Kalifilcon A Daily Disposable Toric Contact Lenses Compared to Commercially Available Daily Disposable Toric Contact Lenses
- ClinicalTrials.gov ID
- NCT06098937
- Acronym / sponsor ID
- ROC-23-007
- Conditions
- Astigmatism
- Keywords
- Contact Lens
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Bausch & Lomb IncorporatedIndustry (pharma, biotech, devices)
- Study start
- 5 Sep 2023 (actual)
- Primary completion
- 27 Sep 2023 (actual)
- Study completion
- 27 Sep 2023 (actual)
- First posted
- 25 Oct 2023 (actual)
- Results
- Posted 10 Dec 2024
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Approximately thirty contact lens adapted subjects will be enrolled in this feasibility, bilateral, randomized, double masked (subject and investigator masked), repeated measures insertion study.
Detailed description
Approximately 30 soft toric contact lens adapted subjects will be enrolled in this feasibility, bilateral, randomized, double masked (subject and investigator masked), repeated measures insertion study. All subjects will be seen for a Screening/Dispensing Visit at which informed consent will be obtained and eligibility will be assessed. If study eligibility is met, subjects will have lenses inserted in random, successive order. Subjects will be receiving each of the study lens types once, in a randomized order. The subject will wear each of the study contact lenses for approximately 10 minutes.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, investigator)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Kalifilcon A Daily Disposable Toric | Experimental | Device: Kalifilcon Toric LensKalifilcon A Daily Disposable Toric |
| Total1 for Astigmatism | Active comparator | Device: Total1 for AstigmatismTotal1 for Astigmatism |
| Precision1 for Astigmatism | Active comparator | Device: Precision1 for AstigmatismPrecision1 for Astigmatism |
| MyDay Toric | Active comparator | Device: MyDay ToricMyDay Toric |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Be 18 years or older on the date the Informed Consent Form (ICF) is signed and have capacity to read, understand and provide written voluntary informed consent.
- Have physiologically normal anterior segments not exhibiting clinically significant biomicroscopy findings.
- Have no active ocular disease or allergic conjunctivitis.
- Not be using any topical ocular medications.
- Be willing and able to follow instructions.
Key exclusion criteria (2 listed)
- Participating in a conflicting study in the opinion of the Investigator.
- Considered by the Investigator to not be a suitable candidate for participation
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 |
|---|---|---|
| Kalifilcon Toric LensKalifilcon A Daily Disposable Toric for Ametropia | Device | Kalifilcon A Daily Disposable Toric |
| Total1 for AstigmatismTotal1 for Astigmatism | Device | Total1 for Astigmatism |
| Precision1 for AstigmatismPrecision1 for Astigmatism | Device | Precision1 for Astigmatism |
| MyDay ToricMyDay Toric | Device | MyDay Toric |
Primary outcome
Primary Gaze Orientation for 5 Minutes
Time frame: 5 minutes after lens insertion
Primary gaze orientation is measured in degrees using a slit lamp and reticule.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Dec 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
Related trials for Astigmatism
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Evaluation of Two Monthly Silicone Hydrogel Multifocal Toric in Soft Contact Lens Wearers
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Kalifilcon Toric Lens, Total1 for Astigmatism and Precision1 for Astigmatism in people with Astigmatism, run by Bausch & Lomb Incorporated 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 6 inclusion and 2 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 10 Dec 2024. 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?
Yes. Results are posted in the registry (first posted 10 Dec 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?
Primary Gaze Orientation for 5 Minutes (time frame: 5 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 10 Dec 2024.