Clinical trial NCT06305663: 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
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
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Myopia
Lead sponsor: Bausch & Lomb Incorporated
Sponsor class: INDUSTRY
First posted: 2024-03-12
Enrollment: 418
Sex: ALL
Minimum age (years): 8
Maximum age (years): 12
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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

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

Eligibility criteria: Inclusion Criteria:

1. 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.
2. Subject must meet the following determined by cycloplegic subjective refraction in both eyes at screening:

   1. Spherical Equivalent Refractive Error (SERE): between -0.75 D and -4.00 D, inclusive.
   2. Astigmatism: ≤ -0.75 D. c. Anisometropia: \< 1.00 D.
3. Subject must be myopic and require lens correction from -0.75 D to -4.00 D, at screening, in each eye.
4. 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.
5. Subject and Parent or Guardian must be willing to participate in either the test or the comparator assignment.
6. 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.
7. Subject must have wearable and visually functioning eyeglasses.
8. Subject must be in good general health according to their and parent's or guardian's knowledge

Exclusion Criteria:

1. Subject has previously worn, or currently wears rigid gas permeable contact lenses, including orthokeratology lenses.
2. Current or prior use of bifocals, progressive addition lenses, multifocal soft contact lenses, atropine, pirenzepine or ANY other myopia control treatment.
3. Subject appears to exhibit poor personal hygiene (that in the Investigator's opinion might prevent safe contact lens wear).
4. Per oral inquiry from parents/guardian, the subject was born earlier than 30 weeks or weighed less than 1,500 g at birth.
5. Prior strabismus, intraocular, or refractive surgery.
6. 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".
7. A known allergy to fluorescein, benoxinate, proparacaine, or cyclopentolate.
8. A history of corneal hypoesthesia (reduced corneal sensitivity), corneal ulcer, corneal infiltrates, ocular viral or fungal infections or other recurrent ocular infections.
9. Strabismus by cover test at far (4 m) or near (40 cm) wearing distance correction.
10. 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.
11. 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.
12. Keratoconus or an irregular cornea.
13. 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.
14. 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.
15. The Investigator for any reason considers that it is not in the best interest of the Subject to participate in the study.
16. 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.
17. Immediate family or close relative is a member of site study team members

Primary outcomes:
measure: Mean change from baseline in axial length.
timeFrame: 1 and 2 years
measure: Mean change from baseline in cycloplegic SERE.
timeFrame: 1 and 2 years
Secondary outcomes:
Other outcomes:
Locations:
city: Beijing
country: China
facility: Site 105
state: Beijing
city: Dongcheng
country: China
facility: Site 107
state: Beijing
city: Xiamen
country: China
facility: Site 109
state: Fujian
city: Haikou
country: China
facility: Site 111
state: Hainan
city: Wuhan
country: China
facility: Site 110
state: Hubei
city: Shanghai
country: China
facility: Site 102
state: Shanghai
city: Taiyuan
country: China
facility: Site 106
state: Shanxi
city: Shenzhen
country: China
facility: Site 108
state: Shenzhen
city: Chengdu
country: China
facility: Site 103
state: Sichaun Province
city: Nankai
country: China
facility: Site 104
state: Tianjin
city: Wenzhou
country: China
facility: Site 101
state: Zhejiang
Study officials:
References: