Myopia and Hyperopia and PresbyopiaNCT05660577
Evaluation of Product Performance of a New Silicone Hydrogel Multifocal Contact Lens
A study testing new silicone hydrogel daily disposable multifocal contact lens, the Bausch + Lomb (kalifilcon A) Daily Disposable Multifocal Contact Lens in people with Myopia and Hyperopia and Presbyopia, run by Bausch & Lomb Incorporated at 20 sites in United States.
Trial summary
The objective of this study is to evaluate the product performance of a new silicone hydrogel daily disposable multifocal contact lens, the Bausch + Lomb (kalifilcon A) Daily Disposable Multifocal Contact Lens, when worn by current soft contact lens wearers on a daily disposable wear basis Read more about this study
- Who is it for?
- Ages 40 years and older
- Conditions the study is for
- Myopia and Hyperopia and Presbyopia
- What is being tested?
- new silicone hydrogel daily disposable multifocal contact lens, the Bausch + Lomb (kalifilcon A) Daily Disposable Multifocal Contact Lens
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 301 participants
- Where
- 20 sitesUnited States
- Study dates
- 7 Nov 2022to 16 Jan 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 40 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Subjects must be age 40 years or older on the date the ICF is signed and have the capacity to provide voluntary informed consent
- Subjects must be willing and able to comply with all treatment and follow-up/study procedures, as well as willing and able to refrain from using any contact lenses other than those provided for the duration of the study
- Subjects must be correctable through spherocylindrical refraction to 42 letters (0.1 logMAR) or better (distance, high contrast) in each eye
- Subjects must have clear central corneas and be free of any anterior segment disorders
- Subject must wear their current lenses for a minimum of 12 hours per day at least four days per week
- Subjects must habitually wear a multifocal lens in each eye
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- Subjects must be an adapted multifocal soft contact lens wearer for a minimum of 6 months
- Subjects must require distance lens correction from +3.00 to -6.00 D in each eye
- Subjects must be presbyopic and require near add correction from +0.75 to +2.50 D in each eye
- Subjects must have access to an internet connection to complete an online survey and be able to receive text message
Who cannot join
- Subjects participating in any drug or device clinical investigation within 30 days prior to entry into this study and/or plan to do so during the period of study participation
- Subjects who are women of childbearing potential (those who are not surgically sterilized or postmenopausal) are excluded from participation in the investigation if they meet any one of the following conditions:
- She is currently pregnant
- She plans to become pregnant during the study
- She is breastfeeding
- Subjects with any systemic disease currently affecting ocular health or that, in the Investigator's opinion, may have an effect on ocular health during the course of the study
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- Subjects with an active ocular disease
- Subjects who have had any corneal surgery (e.g., refractive surgery)
- Subjects who have worn gas-permeable (GP) contact lenses within the last 30 days or who have worn polymethylmethacrylate (PMMA) lenses within the last 3 months
- Subjects who currently wear monovision or toric contact lenses
- Subjects who are not correctable to 32 letters (0.3 logMAR) with bilateral soft multifocal contact lenses
- Subjects with an ocular astigmatism >1.00 D in either eye
- Subjects with anisometropia (spherical equivalent) >2.00 D
- Subjects with any Grade ≥2 finding during the slit lamp examination. Subjects with corneal infiltrates of ANY GRADE are not eligible
- Any "Present" finding during the slit lamp examination that, in the Investigator's opinion, interferes with contact lens wear
- Any scar or neovascularization within the central 6 mm of the cornea. Subjects with minor peripheral corneal scarring (that does not extend into the central area) that, in the Investigator's opinion, does not interfere with contact lens wear are eligible for this study
- Subjects who are amblyopic
- Subjects using any systemic or topical ocular medication that will, in the Investigator's opinion, affect ocular physiology or lens performance
- Subjects who are allergic to any component in the study care products
Trial locations and contacts
20 sites in 1 country.
20 sites in 1 country
United States20 sites
The Eyecare Studio, LLC
Decatur, Georgia, 30035
Chester T Roe III MD Prof LLC
Denver, Colorado, 80246
Cornea and Contact Lens Institute of Minnesota
Edina, Minnesota, 55436
Pearle Vision
Jacksonville, Florida, 32246
Spectrum Eyecare
Jamestown, New York, 14701
Family Eyecare Center
Leavenworth, Kansas, 66048
Total Eye Care, PA
Memphis, Tennessee, 38119
Optometric Physicians of Middle Tennessee
Nashville, Tennessee, 37205
Eola Eyes
Orlando, Florida, 32803
Vision Health Institute
Orlando, Florida, 32803
Kannarr EyeCare
Pittsburg, Kansas, 66762
Casco Bay EyeCare
Portland, Maine, 04101
Oculus Research
Raleigh, North Carolina, 27603
Eric White OD Inc
San Diego, California, 92123
Lee & Woo Optometry
San Francisco, California, 94112
Golden Vision
Sarasota, Florida, 34237
CORE, Inc.
Shelby, North Carolina, 28150
Koetting Associates
St Louis, Missouri, 63144
Saccco Eye Group
Vestal, New York, 13850
West Bay Eye Associates
Warwick, Rhode Island, 02888
About this study
Official title: A Study to Evaluate the Product Performance of a New Silicone Hydrogel Multifocal Contact Lens
The objective of this study is to evaluate the product performance of a new silicone hydrogel daily disposable multifocal contact lens, the Bausch + Lomb (kalifilcon A) Daily Disposable Multifocal Contact Lens, when worn by current soft contact lens wearers on a daily disposable wear basis
- Conditions
- Myopia and Hyperopia and Presbyopia
- Being tested
- new silicone hydrogel daily disposable multifocal contact lens, the Bausch + Lomb (kalifilcon A) Daily Disposable Multifocal Contact Lens
- Medical subject headings
- Myopia, Hyperopia, Presbyopia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
new silicone hydrogel daily disposable multifocal contact lens, the Bausch + Lomb (kalifilcon A) Daily Disposable Multifocal Contact LensDevice
new silicone hydrogel daily disposable multifocal contact lens, the Bausch + Lomb (kalifilcon A) Daily Disposable Multifocal Contact Lens
| Study group | Role | What they receive |
|---|---|---|
| e Bausch + Lomb (kalifilcon A) Daily Disposable Multifocal Contact Lens | Experimental | Not described Receives: Device: new silicone hydrogel daily disposable multifocal contact lens, the Bausch + Lomb (kalifilcon A) Daily Disposable Multifocal Contact Lens |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of Subjects Agreeing With the Statement "Clear Vision: Near, Far, and In-between
Measured: 3 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Dec 2022
- Study start7 Nov 2022
- Primary completion16 Jan 2023
- Study completion16 Jan 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 Myopia and Hyperopia and PresbyopiaStudies 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 301 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
- NCT05660577
- Sponsor's protocol ID
- BL916
- Status last verified
- Feb 2024
- First submitted
- 13 Dec 2022
- Last updated
- 9 Apr 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 9 Apr 2024. 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 Multifocal Contact Lens
- ClinicalTrials.gov ID
- NCT05660577
- Acronym / sponsor ID
- BL916
- Conditions
- Myopia and Hyperopia and Presbyopia
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 301 participants (actual)
- Lead sponsor
- Bausch & Lomb IncorporatedIndustry (pharma, biotech, devices)
- Study start
- 7 Nov 2022 (actual)
- Primary completion
- 16 Jan 2023 (actual)
- Study completion
- 16 Jan 2023 (actual)
- First posted
- 21 Dec 2022 (actual)
- Results
- Posted 9 Apr 2024
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The objective of this study is to evaluate the product performance of a new silicone hydrogel daily disposable multifocal contact lens, the Bausch + Lomb (kalifilcon A) Daily Disposable Multifocal Contact Lens, when worn by current soft contact lens wearers on a daily disposable wear basis
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| e Bausch + Lomb (kalifilcon A) Daily Disposable Multifocal Contact Lens | Experimental | Device: new silicone hydrogel daily disposable multifocal contact lens, the Bausch + Lomb (kalifilcon A) Daily Disposable Multifocal Contact Lens |
Who may qualify
- Ages
- 40 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Subjects must be age 40 years or older on the date the ICF is signed and have the capacity to provide voluntary informed consent
- Subjects must be willing and able to comply with all treatment and follow-up/study procedures, as well as willing and able to refrain from using any contact lenses other than those provided for the duration of the study
- Subjects must be correctable through spherocylindrical refraction to 42 letters (0.1 logMAR) or better (distance, high contrast) in each eye
- Subjects must have clear central corneas and be free of any anterior segment disorders
- Subject must wear their current lenses for a minimum of 12 hours per day at least four days per week
Key exclusion criteria (19 listed)
- Subjects participating in any drug or device clinical investigation within 30 days prior to entry into this study and/or plan to do so during the period of study participation
- Subjects who are women of childbearing potential (those who are not surgically sterilized or postmenopausal) are excluded from participation in the investigation if they meet any one of the following conditions:
- Subjects with any systemic disease currently affecting ocular health or that, in the Investigator's opinion, may have an effect on ocular health during the course of the study
- Subjects with an active ocular disease
- Subjects who have had any corneal surgery (e.g., refractive surgery)
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 |
|---|---|---|
| new silicone hydrogel daily disposable multifocal contact lens, the Bausch + Lomb (kalifilcon A) Daily Disposable Multifocal Contact Lensnew silicone hydrogel daily disposable multifocal contact lens, the Bausch + Lomb (kalifilcon A) Daily Disposable Multifocal Contact Lens | Device | e Bausch + Lomb (kalifilcon A) Daily Disposable Multifocal Contact Lens |
Primary outcome
Proportion of Subjects Agreeing With the Statement "Clear Vision: Near, Far, and In-between
Time frame: 3 weeks
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Apr 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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.
20 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing new silicone hydrogel daily disposable multifocal contact lens, the Bausch + Lomb (kalifilcon A) Daily Disposable Multifocal Contact Lens in people with Myopia and Hyperopia and Presbyopia, run by Bausch & Lomb Incorporated at 20 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 10 inclusion and 19 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 9 Apr 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 20 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 9 Apr 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?
Proportion of Subjects Agreeing With the Statement "Clear Vision: Near, Far, and In-between (time frame: 3 weeks). 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 9 Apr 2024.