Habitual Soft Contact Lens UseNCT04555031

Evaluation of Surface Refractive Index Shift of Kalifilcon A Lenses Compared to Dailies Total 1, Precision 1 and Biotrue ONEday Lenses

A study testing kalifilcon A lenses, Dalies Total 1 and Precision 1 in people with Habitual Soft Contact Lens Use, run by Bausch & Lomb Incorporated at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Who is it for?: Ages 18 years and older
Conditions the study is for: Habitual Soft Contact Lens Use
What is being tested?: kalifilcon A lenses, Dalies Total 1 and Precision 1
Type of treatment: Medical device
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 10 participants
Where: 1 siteUnited States
Study dates: 9 Sep 2020to 16 Sep 2020
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

18 years or older and have full legal capacity to volunteer.
Physiologically normal anterior segments not exhibiting clinically significant biomicroscopy findings.
No active ocular disease or allergic conjunctivitis.
Not using any topical ocular medications.
Willing and able to follow instructions.
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 and Lomb Site 01
Rochester, New York, 14609

Other trials in United States

About this study

Approximately 20 habitual soft contact lens wearing participants will be enrolled in this unilateral, randomized, double-masked (participant and investigator masked) repeated measures insertion study. All participants will be seen for a Screening/Dispensing Visit at which informed consent will be obtained and eligibility will be assessed. If participants satisfy all eligibility criteria and none of the exclusion criteria, subjects will insert study lenses in random, successive order according to unique randomization schedules that will be provided to each Investigator.

Conditions: Habitual Soft Contact Lens Use
Being tested: kalifilcon A lenses, Dalies Total 1, Precision 1, Biotrue ONEday

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

kalifilcon A lensesDevice
Participant will wear the lens for each timepoint of 5, 10 and 15 minutes. A new lens will be inserted for each timepoint.
Dalies Total 1Device
Participant will wear the lens for each timepoint of 5, 10 and 15 minutes. A new lens will be inserted for each timepoint.
Precision 1Device
Participant will wear the lens for each timepoint of 5, 10 and 15 minutes. A new lens will be inserted for each timepoint.
Biotrue ONEdayDevice
Participant will wear the lens for each timepoint of 5, 10 and 15 minutes. A new lens will be inserted for each timepoint.

Study groups in NCT04555031
Study group	Role	What they receive
kalifilcon A lenses	Experimental	Not described Receives: Device: kalifilcon A lenses
Dailies Total 1	Active comparator	Not described Receives: Device: Dalies Total 1
Precision 1	Active comparator	Not described Receives: Device: Precision 1
Biotrue ONEday	Active comparator	Not described Receives: Device: Biotrue ONEday

What is being measured

The primary outcome is the main question the study is designed to answer.

Surface Refractive Index Shifts at 5 Minutes
Refractive index is the ratio of velocity of light in a material divided with velocity of light in vacuum. The eye was measured for surface refractive index on the refractometer. The refractive index of a medium is the ratio of the speed of light in vacuum to the speed of light in the medium. It has no units.
Measured: 5 minutes
Surface Refractive Index Shifts at 10 Minutes
Refractive index is the ratio of velocity of light in a material divided with velocity of light in vacuum. The eye was measured for surface refractive index on the refractometer. The refractive index of a medium is the ratio of the speed of light in vacuum to the speed of light in the medium. It has no units.
Measured: 10 minutes
Surface Refractive Index Shifts at 15 Minutes
Refractive index is the ratio of velocity of light in a material divided with velocity of light in vacuum. The eye was measured for surface refractive index on the refractometer. The refractive index of a medium is the ratio of the speed of light in vacuum to the speed of light in the medium. It has no units.
Measured: 15 minutes

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

9 Sep 202016 Sep 2020

First posted18 Sep 2020
Study start9 Sep 2020
Primary completion16 Sep 2020
Study completion16 Sep 2020

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 Habitual Soft Contact Lens UseStudies 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: 10 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT04555031
Sponsor's protocol ID: ROC2-20-012
Status last verified: Oct 2021
First submitted: 11 Sep 2020
Last updated: 8 Nov 2021
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: Yes
Individual data sharing: Undecided

Study at a glance

From the registry record, last updated by the sponsor on 8 Nov 2021. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Evaluation of Surface Refractive Index Shift of Kalifilcon A Lenses Compared to Dailies Total 1, Precision 1 and Biotrue ONEday Lenses
ClinicalTrials.gov ID: NCT04555031
Acronym / sponsor ID: ROC2-20-012
Conditions: Habitual Soft Contact Lens Use
Study type: Interventional
Recruitment status: Completed
Enrolment: 10 participants (actual)
Lead sponsor: Bausch & Lomb IncorporatedIndustry (pharma, biotech, devices)
Study start: 9 Sep 2020 (actual)
Primary completion: 16 Sep 2020 (actual)
Study completion: 16 Sep 2020 (actual)
First posted: 18 Sep 2020 (actual)
Results: Posted 8 Nov 2021

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Crossover
Masking: Double blind (participant, investigator)
Number of arms: 4

Arm	Type	Receives
kalifilcon A lenses	Experimental	Device: kalifilcon A lenses
Dailies Total 1	Active comparator	Device: Dalies Total 1
Precision 1	Active comparator	Device: Precision 1
Biotrue ONEday	Active comparator	Device: Biotrue ONEday

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (6 listed)

18 years or older and have full legal capacity to volunteer.
Physiologically normal anterior segments not exhibiting clinically significant biomicroscopy findings.
No active ocular disease or allergic conjunctivitis.
Not using any topical ocular medications.
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 A lensesParticipant will wear the lens for each timepoint of 5, 10 and 15 minutes. A new lens will be inserted for each timepoint.	Device	kalifilcon A lenses
Dalies Total 1Participant will wear the lens for each timepoint of 5, 10 and 15 minutes. A new lens will be inserted for each timepoint.	Device	Dailies Total 1
Precision 1Participant will wear the lens for each timepoint of 5, 10 and 15 minutes. A new lens will be inserted for each timepoint.	Device	Precision 1
Biotrue ONEdayParticipant will wear the lens for each timepoint of 5, 10 and 15 minutes. A new lens will be inserted for each timepoint.	Device	Biotrue ONEday

Primary outcome

Surface Refractive Index Shifts at 5 Minutes
Time frame: 5 minutes
Refractive index is the ratio of velocity of light in a material divided with velocity of light in vacuum. The eye was measured for surface refractive index on the refractometer. The refractive index of a medium is the ratio of the speed of light in vacuum to the speed of light in the medium. It has no units.
Surface Refractive Index Shifts at 10 Minutes
Time frame: 10 minutes
Refractive index is the ratio of velocity of light in a material divided with velocity of light in vacuum. The eye was measured for surface refractive index on the refractometer. The refractive index of a medium is the ratio of the speed of light in vacuum to the speed of light in the medium. It has no units.
Surface Refractive Index Shifts at 15 Minutes
Time frame: 15 minutes
Refractive index is the ratio of velocity of light in a material divided with velocity of light in vacuum. The eye was measured for surface refractive index on the refractometer. The refractive index of a medium is the ratio of the speed of light in vacuum to the speed of light in the medium. It has no units.

Results and safety

Results posted to the registry on 8 Nov 2021, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
All Participants	10	10

Primary outcome: Surface Refractive Index Shifts at 5 Minutes

Time frame: 5 minutes. Mean (Standard Deviation). Unit: No units

Measure	Kalifilcon A Lenses n = 10	Dailies Total 1 n = 10	Precision 1 n = 10	Biotrue ONEday n = 10
Value	1.4102 (0.00220)	1.4251 (0.00274)	1.4188 (0.00380)	1.3788 (0.00157)

Population analysed: Participants wore each lens type for 5, 10 and 15 minutes in a randomly assigned fashion. The surface refractive index was measured at each timepoint. All participants completed the study. All 10 participants completed kalifilcon A lens wear, all 10 participants completing Dailies Total 1 wear, all 10 participants completed Precision 1 wear, and all 10 participants completed Biotrue ONEday wear. There were 10 participants total who wore each lens type for 5, 10 and 15 minutes each.

Primary outcome: Surface Refractive Index Shifts at 10 Minutes

Time frame: 10 minutes. Mean (Standard Deviation). Unit: No units

Measure	Kalifilcon A Lenses n = 10	Dailies Total 1 n = 10	Precision 1 n = 10	Biotrue ONEday n = 10
Value	1.4102 (0.00241)	1.4267 (0.00113)	1.4182 (0.00286)	1.3786 (0.00080)

Primary outcome: Surface Refractive Index Shifts at 15 Minutes

Time frame: 15 minutes. Mean (Standard Deviation). Unit: No units

Measure	Kalifilcon A Lenses n = 10	Dailies Total 1 n = 10	Precision 1 n = 10	Biotrue ONEday n = 10
Value	1.4105 (0.00163)	1.4238 (0.00213)	1.4188 (0.00306)	1.3793 (0.00150)

Adverse events

Time frame: 4 days. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
All Participants	0 of 10 (0%)	0 of 10 (0%)	0 of 10

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 8 Nov 2021.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Individual participant dataSharing planned: Undecided

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.

Jeffery Schafer, OD principal investigator

Bausch & Lomb Incorporated

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 A lenses, Dalies Total 1 and Precision 1 in people with Habitual Soft Contact Lens Use, 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 8 Nov 2021. 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 8 Nov 2021). 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?

Surface Refractive Index Shifts at 5 Minutes (time frame: 5 minutes). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04555031.

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 8 Nov 2021.