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 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
1 other identifier
interventional
418
1 country
11
Brief 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
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Mar 2024
Typical duration for not_applicable
11 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
March 5, 2024
CompletedFirst Posted
Study publicly available on registry
March 12, 2024
CompletedStudy Start
First participant enrolled
March 29, 2024
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 31, 2027
ExpectedStudy Completion
Last participant's last visit for all outcomes
January 31, 2027
June 15, 2025
June 1, 2025
2.8 years
March 5, 2024
June 13, 2025
Conditions
Outcome Measures
Primary Outcomes (2)
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.
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.
1 and 2 years
Study Arms (2)
Bausch + Lomb (kalifilcon A) Myopia Control Soft (Hydrophilic)
EXPERIMENTALCooperVision MiSight (omafilcon A/60%) Myopia Control one day Soft Contact Lens
ACTIVE COMPARATORInterventions
Bausch + Lomb (kalifilcon A) Myopia Control Soft (Hydrophilic)
CooperVision MiSight (omafilcon A/60%) Myopia Control one day Soft Contact Lens
Eligibility Criteria
You may qualify if:
- 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.
- 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
You may not qualify if:
- 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".
- 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.
- +2 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (11)
Site 105
Beijing, Beijing Municipality, 100044, China
Site 107
Dongcheng, Beijing Municipality, 100730, China
Site 109
Xiamen, Fujian, 361004, China
Site 111
Haikou, Hainan, 570311, China
Site 110
Wuhan, Hubei, 430012, China
Site 102
Shanghai, Shanghai Municipality, 200433, China
Site 106
Taiyuan, Shanxi, 030072, China
Site 108
Shenzhen, Shenzhen, 518040, China
Site 103
Chengdu, Sichaun Province, 610044, China
Site 104
Nankai, Tianjin Municipality, 300392, China
Site 101
Wenzhou, Zhejiang, 325027, China
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, OUTCOMES ASSESSOR
- Masking Details
- The identity of the study eye will be masked to subjects, assessors, and other masked personnel while masking is maintained..
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
March 5, 2024
First Posted
March 12, 2024
Study Start
March 29, 2024
Primary Completion (Estimated)
January 31, 2027
Study Completion (Estimated)
January 31, 2027
Last Updated
June 15, 2025
Record last verified: 2025-06