MyopiaNCT06305663
A Study to Evaluate the Safety and Efficacy of the Bausch + Lomb Myopia Control Lens for the Correction of Myopic Ametropia and Slowing the Progression of Myopia in Children
A study of Myopia, run by Bausch & Lomb Incorporated at 11 sites in China.
Trial summary
A Study to Evaluate the Safety and Efficacy of the Bausch + Lomb Myopia Control Lens for the Correction of Myopic Ametropia and Slowing the Progression of Myopia in Children Read more about this study
- Who is it for?
- Ages 8 to 12 years
- Conditions the study is for
- Myopia
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 418 participants
- Where
- 11 sitesChina
- Study dates
- 29 Mar 2024to 31 Jan 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 8 to 12 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Male or female aged 8 to 12 years plus 11 months old on the date the Informed Assent and Parental or Guardian Informed Consent are signed and have capacity to provide voluntary informed consent.
- Subject must meet the following determined by cycloplegic subjective refraction in both eyes at screening:
- Spherical Equivalent Refractive Error (SERE): between -0.75 D and -4.00 D, inclusive.
- Astigmatism: ≤ -0.75 D. c. Anisometropia: < 1.00 D.
- Subject must be myopic and require lens correction from -0.75 D to -4.00 D, at screening, in each eye.
- Subject must have distance best-spectacle corrected visual acuity (BSCVA) by non-cycloplegic manifest refraction of +0.04 logMAR (20/20 Snellen equivalent) or better in each eye.
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- Subject and Parent or Guardian must be willing to participate in either the test or the comparator assignment.
- Subject agrees to wear the assigned contact lenses for a minimum of 10 hours per day, at least 6 days per week, for the duration of the 24-month study.
- Subject must have wearable and visually functioning eyeglasses.
- Subject must be in good general health according to their and parent's or guardian's knowledge
Who cannot join
- Subject has previously worn, or currently wears rigid gas permeable contact lenses, including orthokeratology lenses.
- Current or prior use of bifocals, progressive addition lenses, multifocal soft contact lenses, atropine, pirenzepine or ANY other myopia control treatment.
- Subject appears to exhibit poor personal hygiene (that in the Investigator's opinion might prevent safe contact lens wear).
- Per oral inquiry from parents/guardian, the subject was born earlier than 30 weeks or weighed less than 1,500 g at birth.
- Prior strabismus, intraocular, or refractive surgery.
- Subject using any systemic or local eye medication that interfere with the wearing of corneal contact lenses, pupil size, adjustment or refractive status, or require the removal of lenses during the day".
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- A known allergy to fluorescein, benoxinate, proparacaine, or cyclopentolate.
- A history of corneal hypoesthesia (reduced corneal sensitivity), corneal ulcer, corneal infiltrates, ocular viral or fungal infections or other recurrent ocular infections.
- Strabismus by cover test at far (4 m) or near (40 cm) wearing distance correction.
- Known ocular or systemic disease such as, but not limited to: anterior uveitis or iritis, episcleritis or scleritis, glaucoma, Sjögren's syndrome, lupus erythematosus, scleroderma, or diabetes.
- At the discretion of the Investigator, any ocular, systemic or neuro developmental conditions that could influence refractive development such as, but not limited to: persistent pupillary membrane, vitreous hemorrhage, cataract, corneal scarring, ptosis, eyelid hemangiomas, Marfan's syndrome, Down syndrome, Ehlers-Danlos syndrome, Stickler syndrome, ocular albinism, retinopathy of prematurity. Subjects with trichiasis, that in the Investigator's judgement does not interfere with contact lens wear, are eligible for this study.
- Keratoconus or an irregular cornea.
- Subjects with any Grade 2 or greater finding during the slit lamp examination, or subjects with any scar or neovascularization within the central 6 mm of the cornea, or subjects with corneal infiltrates, of ANY GRADE.
- Subjects with any "present" finding during the slit lamp examination (biomicroscopy) that, in the investigator's judgment, interferes with contact lens wear. Subjects with minor peripheral corneal scarring (that does not extend into the central area), that in the Investigator's judgment does not interfere with contact lens wear, are eligible for this study.
- The Investigator for any reason considers that it is not in the best interest of the Subject to participate in the study.
- Subjects participating in any drug clinical investigation within 4 weeks or device clinical investigation within 2 weeks prior to entry into this study (Screening/Dispensing Visit) and/or planning to do so during the period of study participation.
- Immediate family or close relative is a member of site study team members
Trial locations and contacts
11 sites in 1 country. Contact the study team or a site near you to ask about taking part.
11 sites in 1 country
China11 sites, 1 recruiting
- Active, not recruiting
Site 105
Beijing, Beijing Municipality, 100044
- Active, not recruiting
Site 103
Chengdu, Sichaun Province, 610044
- Active, not recruiting
Site 107
Dongcheng, Beijing Municipality, 100730
- Active, not recruiting
Site 111
Haikou, Hainan, 570311
- Active, not recruiting
Site 104
Nankai, Tianjin Municipality, 300392
- Active, not recruiting
Site 102
Shanghai, Shanghai Municipality, 200433
- Active, not recruiting
Site 108
Shenzhen, Shenzhen, 518040
- Active, not recruiting
Site 106
Taiyuan, Shanxi, 030072
- Recruiting
Site 101
Wenzhou, Zhejiang, 325027
- Active, not recruiting
Site 110
Wuhan, Hubei, 430012
- Active, not recruiting
Site 109
Xiamen, Fujian, 361004
About this study
Official title: A Multi-center, Randomized, Parallel, Bilateral, Investigator-masked Study to Evaluate the Safety and Efficacy of the Bausch + Lomb Myopia Control Lens for the Correction of Myopic Ametropia and Slowing the Progression of Myopia in Children
A Study to Evaluate the Safety and Efficacy of the Bausch + Lomb Myopia Control Lens for the Correction of Myopic Ametropia and Slowing the Progression of Myopia in Children
Read the detailed description
A Multi-center, Randomized, Parallel, Bilateral, Investigator-masked study to Evaluate the Safety and Efficacy of the Bausch + Lomb Myopia Control Lens for the Correction of Myopic Ametropia and Slowing the Progression of Myopia in Children
- Conditions
- Myopia
- Being tested
- Bausch + Lomb (kalifilcon A) Myopia Control Soft (Hydrophilic), CooperVision MiSight (omafilcon A/60%) Myopia Control one day Soft Contact Lens
- Medical subject headings
- Myopia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Bausch + Lomb (kalifilcon A) Myopia Control Soft (Hydrophilic)Device
Bausch + Lomb (kalifilcon A) Myopia Control Soft (Hydrophilic)
CooperVision MiSight (omafilcon A/60%) Myopia Control one day Soft Contact LensDevice
CooperVision MiSight (omafilcon A/60%) Myopia Control one day Soft Contact Lens
| Study group | Role | What they receive |
|---|---|---|
| Bausch + Lomb (kalifilcon A) Myopia Control Soft (Hydrophilic) | Experimental | Not described Receives: Device: Bausch + Lomb (kalifilcon A) Myopia Control Soft (Hydrophilic) |
| CooperVision MiSight (omafilcon A/60%) Myopia Control one day Soft Contact Lens | Active comparator | Not described Receives: Device: CooperVision MiSight (omafilcon A/60%) Myopia Control one day Soft Contact Lens |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mean change from baseline in axial length.
Mean change from baseline in axial length will be evaluated at the one-year and two-year visits.
Measured: 1 and 2 years
Mean change from baseline in cycloplegic SERE.
Mean change from baseline in cycloplegic SERE will be evaluated at the one-year and two-year visits.
Measured: 1 and 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Mar 2024
- Study start29 Mar 2024
- Primary completion31 Jan 2027 (estimated)
- Study completion31 Jan 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Single group
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 418 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Bausch & Lomb Incorporated
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06305663
- Sponsor's protocol ID
- 921
- Status last verified
- Jun 2025
- First submitted
- 5 Mar 2024
- Last updated
- 15 Jun 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multi-center, Randomized, Parallel, Bilateral, Investigator-masked Study to Evaluate the Safety and Efficacy of the Bausch + Lomb Myopia Control Lens for the Correction of Myopic Ametropia and Slowing the Progression of Myopia in Children
- ClinicalTrials.gov ID
- NCT06305663
- Acronym / sponsor ID
- 921
- Conditions
- Myopia
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 418 participants (estimated)
- Lead sponsor
- Bausch & Lomb IncorporatedIndustry (pharma, biotech, devices)
- Study start
- 29 Mar 2024 (actual)
- Primary completion
- 31 Jan 2027 (estimated)
- Study completion
- 31 Jan 2027 (estimated)
- First posted
- 12 Mar 2024 (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.
A Study to Evaluate the Safety and Efficacy of the Bausch + Lomb Myopia Control Lens for the Correction of Myopic Ametropia and Slowing the Progression of Myopia in Children
Detailed description
A Multi-center, Randomized, Parallel, Bilateral, Investigator-masked study to Evaluate the Safety and Efficacy of the Bausch + Lomb Myopia Control Lens for the Correction of Myopic Ametropia and Slowing the Progression of Myopia in Children
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Bausch + Lomb (kalifilcon A) Myopia Control Soft (Hydrophilic) | Experimental | Device: Bausch + Lomb (kalifilcon A) Myopia Control Soft (Hydrophilic) |
| CooperVision MiSight (omafilcon A/60%) Myopia Control one day Soft Contact Lens | Active comparator | Device: CooperVision MiSight (omafilcon A/60%) Myopia Control one day Soft Contact Lens |
Who may qualify
- Ages
- 8 to 12 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (10 listed)
- Male or female aged 8 to 12 years plus 11 months old on the date the Informed Assent and Parental or Guardian Informed Consent are signed and have capacity to provide voluntary informed consent.
- Subject must meet the following determined by cycloplegic subjective refraction in both eyes at screening:
- Subject must be myopic and require lens correction from -0.75 D to -4.00 D, at screening, in each eye.
- Subject must have distance best-spectacle corrected visual acuity (BSCVA) by non-cycloplegic manifest refraction of +0.04 logMAR (20/20 Snellen equivalent) or better in each eye.
- Subject and Parent or Guardian must be willing to participate in either the test or the comparator assignment.
Key exclusion criteria (17 listed)
- Subject has previously worn, or currently wears rigid gas permeable contact lenses, including orthokeratology lenses.
- Current or prior use of bifocals, progressive addition lenses, multifocal soft contact lenses, atropine, pirenzepine or ANY other myopia control treatment.
- Subject appears to exhibit poor personal hygiene (that in the Investigator's opinion might prevent safe contact lens wear).
- Per oral inquiry from parents/guardian, the subject was born earlier than 30 weeks or weighed less than 1,500 g at birth.
- Prior strabismus, intraocular, or 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 |
|---|---|---|
| Bausch + Lomb (kalifilcon A) Myopia Control Soft (Hydrophilic)Bausch + Lomb (kalifilcon A) Myopia Control Soft (Hydrophilic) | Device | Bausch + Lomb (kalifilcon A) Myopia Control Soft (Hydrophilic) |
| CooperVision MiSight (omafilcon A/60%) Myopia Control one day Soft Contact LensCooperVision MiSight (omafilcon A/60%) Myopia Control one day Soft Contact Lens | Device | CooperVision MiSight (omafilcon A/60%) Myopia Control one day Soft Contact Lens |
Primary outcome
Mean change from baseline in axial length.
Time frame: 1 and 2 years
Mean change from baseline in axial length will be evaluated at the one-year and two-year visits.
Mean change from baseline in cycloplegic SERE.
Time frame: 1 and 2 years
Mean change from baseline in cycloplegic SERE will be evaluated at the one-year and two-year visits.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Jun 2025.
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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.
11 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study of Myopia, run by Bausch & Lomb Incorporated at 11 sites in China.
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 17 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: looking for participants now, as of the sponsor's last update on 15 Jun 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 11 sites in China. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Yan Zhang (+86 21 60327166, Yan.Zhang1@bausch.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Mean change from baseline in axial length. (time frame: 1 and 2 years). The study lists 2 primary outcomes in all. 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 15 Jun 2025.