MyopiaNCT04901897

Product Performance of a New Silicone Hydrogel Contact Lens

A study testing kalifilcon A, delefilcon A and senofilcon A in people with Myopia, run by Bausch & Lomb Incorporated at 35 sites 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

The objective of this study is to evaluate the product performance of kalifilcon A, compared to the Johnson \& Johnson Acuvue Oasys® 1-Day with HydraLuxe™ (senofilcon A) daily disposable contact lens and Alcon DAILIES TOTAL1® (delefilcon A) daily disposable contact lenses when worn by current soft contact lens wearers… Read more about this study

Who is it for?: Ages 18 to 40 years
Conditions the study is for: Myopia
What is being tested?: kalifilcon A, delefilcon A and senofilcon A
Type of treatment: Medical device
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 805 participants
Where: 35 sitesUnited States
Study dates: 31 Jul 2019to 9 Oct 2019
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 to 40 years
All sexes
No healthy volunteers
Adult

Who may be able to join

18 to 40 years old on the date the ICF is signed and have capacity to provide voluntary informed consent.
myopic and require lens correction from -0.50 to -6.00 Diopter (D) with 0.25 D steps, in each eye.
correctable through spherocylindrical refraction and with soft spherical contact lenses to 32 letters (0.3 logarithm of the minimum angle of resolution [logMAR]) or better (2 meters distance, high-contrast chart) in each eye.
free of any anterior segment disorders.
adapted soft contact lens wearers and willing to wear their study lenses for at least 8 hours per day on a daily disposable wear basis for approximately 2 weeks.
access to internet connection and personal email to send/receive emails.
habitually wear either Alcon's Air Optix Aqua, Air Optix with HydraGlyde, Air Optix Night \& Day, Bausch + Lomb's PureVision 2, Bausch + Lomb ULTRA, CooperVision's Biofinity, Johnson \& Johnson Acuvue Oasys® with HydraClear™, or Acuvue Vita soft contact lenses.

Who cannot join

participating in any drug or device clinical investigation within 2 weeks prior to entry into this study (Screening/Dispensing Visit) and/or during the period of study participation.
have worn gas permeable (GP) contact lenses within the last 30 days or who have worn polymethylmethacrylate (PMMA) lenses within the last three months.
have any systemic or ocular disease currently affecting ocular health in the Investigator's opinion may have an effect on ocular health during the course of the study.
using any systemic, topical or topical ocular medications that will in the Investigator's opinion, affect ocular physiology or lens performance.currently wear daily disposable, monovision, multifocal, or toric contact lenses.
refractive astigmatism of greater than 0.75 D in either eye.
anisometropia (spherical equivalent) of greater than 2.00 D.
amblyopic.
have had any corneal surgery (e.g., refractive surgery).

Trial locations and contacts

35 sites in 1 country.

City, postcode or hospital

35 sites in 1 country

United States35 sites

Bausch Site 401
‘Aiea, Hawaii, 96701
Bausch Site 406
Azusa, California, 91702
Bausch Site 433
Birmingham, Alabama, 35216
Bausch 410
Brentwood, Tennessee, 37027
Bausch Site 412
Decatur, Georgia, 30035
Bausch Site 416
Denver, Colorado, 80246
Bausch Site 429
Edina, Minnesota, 55436
Bausch Site 411
Fargo, North Dakota, 58103
Bausch Site 428
Grants Pass, Oregon, 97526
Bausch Site 437
Honolulu, Hawaii, 96814
Bausch Site 415
Jacksonville, Florida, 32256
Bausch Site 434
Jacksonville, Florida, 32256
Bausch Site 424
Jamestown, New York, 14701
Bausch Site 426
League City, Texas, 77573
Bausch Site 414
Leavenworth, Kansas, 66048
Bausch Site 430
Los Angeles, California, 90013
Bausch Site 408
Memphis, Tennessee, 33119
Bausch Site 423
Miamisburg, Ohio, 45342
Bausch Site 404
Nashville, Tennessee, 37205
Bausch Site 413
Portland, Maine, 04101
Bausch Site 417
Raleigh, North Carolina, 27603
Bausch Site 422
Raytown, Missouri, 64133
Bausch Site 419
San Diego, California, 92123
Bausch Site 435
San Francisco, California, 94112
Bausch Site 405
Sarasota, Florida, 34237
Bausch Site 431
Scottsdale, Arizona, 85254
Bausch Site 407
St Louis, Missouri, 63144
Bausch Site 420
State College, Pennsylvania, 16801
Bausch Site 421
Sterling Heights, Michigan, 48312
Bausch Site 432
Sunnyvale, California, 94087
Bausch Site 409
Torrance, California, 90503
Bausch Site 403
Vestal, New York, 13850
Bausch Site 418
Warrensburg, Missouri, 64093
Bausch Site 427
Warwick, Rhode Island, 02888
Bausch Site 425
West Chester, Ohio, 45069

Other trials in United States

About this study

Official title: A Study to Evaluate the Product Performance of a New Silicone Hydrogel Contact Lens

Conditions: Myopia
Being tested: kalifilcon A, delefilcon A, senofilcon A
Medical subject headings: Myopia

What participants receive

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

kalifilcon ADevice
kalifilcon A daily disposable contact lens
delefilcon ADevice
DAILIES TOTAL1® (delefilcon A) daily disposable contact lenses
senofilcon ADevice
Acuvue Oasys® 1-Day with HydraLuxe™ (senofilcon A) daily disposable contact lens

Study groups in NCT04901897
Study group	Role	What they receive
kalifilcon A	Experimental	kalifilcon A daily disposable contact lens Receives: Device: kalifilcon A
delefilcon A	Active comparator	DAILIES TOTAL1® (delefilcon A) daily disposable contact lenses Receives: Device: delefilcon A
senofilcon A	Active comparator	Acuvue Oasys® 1-Day with HydraLuxe™ (senofilcon A) daily disposable contact lens Receives: Device: senofilcon A

What is being measured

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

Mean Change in logMAR Contact Lens Visual Acuity
logMAR is the logarithm of the minim angle of resolution
Measured: Baseline, 2 Week Follow up
Percentage of Participants in the Test Lens Group Agreeing With the Statement "Are Comfortable Throughout the Day"
Measured: 2 Week Follow up
Percentage of Participants in the Test Lens Group Agreeing With the Statement "Provide Clear Vision Throughout the Day"
Measured: 2 Week Follow up

Timeline

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

31 Jul 20199 Oct 2019

First posted26 May 2021
Study start31 Jul 2019
Primary completion9 Oct 2019
Study completion9 Oct 2019

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: Single blind
Who is masked: Investigator
Enrolment: 805 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT04901897
Sponsor's protocol ID: 893
Status last verified: Jun 2021
First submitted: 21 May 2021
Last updated: 8 Jul 2021
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: Yes
Individual data sharing: Undecided

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Managing Premyopia in Chinese Children Using Artificial Intelligence Assisted Defocus Incorporated Multiple Segments Based Spectacle Lens: a Randomized Controlled Clinical Trial
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BRIGHT-LIGHT: Studying Red Light Therapy for Severe Short-Sightedness or Short-Sightedness That Worsens Despite Standard Treatment
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Clinical Performance and Outcomes After Toric Lens Transition
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All Myopia trials

Study at a glance

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

Official title: A Study to Evaluate the Product Performance of a New Silicone Hydrogel Contact Lens
ClinicalTrials.gov ID: NCT04901897
Acronym / sponsor ID: 893
Conditions: Myopia
Study type: Interventional
Recruitment status: Completed
Enrolment: 805 participants (actual)
Lead sponsor: Bausch & Lomb IncorporatedIndustry (pharma, biotech, devices)
Study start: 31 Jul 2019 (actual)
Primary completion: 9 Oct 2019 (actual)
Study completion: 9 Oct 2019 (actual)
First posted: 26 May 2021 (actual)
Results: Posted 8 Jul 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: Parallel groups
Masking: Single blind (investigator)
Number of arms: 3

Arm	Type	Receives
kalifilcon A	Experimental	Device: kalifilcon Akalifilcon A daily disposable contact lens
delefilcon A	Active comparator	Device: delefilcon ADAILIES TOTAL1® (delefilcon A) daily disposable contact lenses
senofilcon A	Active comparator	Device: senofilcon AAcuvue Oasys® 1-Day with HydraLuxe™ (senofilcon A) daily disposable contact lens

Who may qualify

Ages: 18 to 40 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult

Key inclusion criteria (7 listed)

18 to 40 years old on the date the ICF is signed and have capacity to provide voluntary informed consent.
myopic and require lens correction from -0.50 to -6.00 Diopter (D) with 0.25 D steps, in each eye.
correctable through spherocylindrical refraction and with soft spherical contact lenses to 32 letters (0.3 logarithm of the minimum angle of resolution [logMAR]) or better (2 meters distance, high-contrast chart) in each eye.
free of any anterior segment disorders.
adapted soft contact lens wearers and willing to wear their study lenses for at least 8 hours per day on a daily disposable wear basis for approximately 2 weeks.

Key exclusion criteria (8 listed)

participating in any drug or device clinical investigation within 2 weeks prior to entry into this study (Screening/Dispensing Visit) and/or during the period of study participation.
have worn gas permeable (GP) contact lenses within the last 30 days or who have worn polymethylmethacrylate (PMMA) lenses within the last three months.
have any systemic or ocular disease currently affecting ocular health in the Investigator's opinion may have an effect on ocular health during the course of the study.
using any systemic, topical or topical ocular medications that will in the Investigator's opinion, affect ocular physiology or lens performance.currently wear daily disposable, monovision, multifocal, or toric contact lenses.
refractive astigmatism of greater than 0.75 D in either eye.

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 Akalifilcon A daily disposable contact lens	Device	kalifilcon A
delefilcon ADAILIES TOTAL1® (delefilcon A) daily disposable contact lenses	Device	delefilcon A
senofilcon AAcuvue Oasys® 1-Day with HydraLuxe™ (senofilcon A) daily disposable contact lens	Device	senofilcon A

Primary outcome

Mean Change in logMAR Contact Lens Visual Acuity
Time frame: Baseline, 2 Week Follow up
logMAR is the logarithm of the minim angle of resolution
Percentage of Participants in the Test Lens Group Agreeing With the Statement "Are Comfortable Throughout the Day"
Time frame: 2 Week Follow up
Percentage of Participants in the Test Lens Group Agreeing With the Statement "Provide Clear Vision Throughout the Day"
Time frame: 2 Week Follow up

Results and safety

Results posted to the registry on 8 Jul 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
Kalifilcon A	398	393
Delefilcon A	202	200
Senofilcon A	205	203

Primary outcome: Mean Change in logMAR Contact Lens Visual Acuity

Time frame: Baseline, 2 Week Follow up. Mean (Standard Deviation). Unit: logMAR

Measure	Kalifilcon A n = 398	Delefilcon A n = 202	Senofilcon A n = 205
Value	-0.056 (0.0727)	-0.069 (0.0733)	-0.069 (0.0718)

Primary outcome: Percentage of Participants in the Test Lens Group Agreeing With the Statement "Are Comfortable Throughout the Day"

Time frame: 2 Week Follow up. Count of participants. Unit: Participants

Measure	Kalifilcon A n = 391	Delefilcon A n = 200	Senofilcon A n = 199
Value	317	160	166

Population analysed: Participants with 2 week follow up and responded to the question.

Primary outcome: Percentage of Participants in the Test Lens Group Agreeing With the Statement "Provide Clear Vision Throughout the Day"

Time frame: 2 Week Follow up. Count of participants. Unit: Participants

Measure	Kalifilcon A n = 392	Delefilcon A n = 201	Senofilcon A n = 201
Value	358	184	188

Population analysed: Participants with 2 week follow up and responded to the question.

Adverse events

Time frame: 2 weeks. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Kalifilcon A	0 of 398 (0%)	0 of 398 (0%)	0 of 398
Delefilcon A	0 of 202 (0%)	0 of 202 (0%)	0 of 202
Senofilcon A	0 of 205 (0%)	0 of 205 (0%)	0 of 205

Loading the posted results from ClinicalTrials.gov…

Research links

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

Related trials for Myopia

Recruiting
Managing Premyopia in Chinese Children Using Artificial Intelligence Assisted Defocus Incorporated Multiple Segments Based Spectacle Lens: a Randomized Controlled Clinical Trial
Pre-myopia, Myopia
Not yet recruiting
BRIGHT-LIGHT: Studying Red Light Therapy for Severe Short-Sightedness or Short-Sightedness That Worsens Despite Standard Treatment
Myopia, Myopia Progressing
Not yet recruiting
Clinical Performance and Outcomes After Toric Lens Transition
Astigmatism
Active, not recruiting
Effect of IOP Lowering on Progressive HM
High Myopia, Intraocular Pressure
Recruiting
Evaluation of a New Laser Refractive Vision Correction Using the TENEO™ 317 Model 2
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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.

Robert Steffen study director

Bausch & Lomb Incorporated

35 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing kalifilcon A, delefilcon A and senofilcon A in people with Myopia, run by Bausch & Lomb Incorporated at 35 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 7 inclusion and 8 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 Jul 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 35 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 8 Jul 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?

Mean Change in logMAR Contact Lens Visual Acuity (time frame: Baseline, 2 Week Follow up). 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 NCT04901897.

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 Jul 2021.