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

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

Study Overview

• Status: Not yet recruiting
• Conditions: Myopia
• Intervention / Treatment: Device: Bausch + Lomb (kalifilcon A) Myopia Control Soft (Hydrophilic); Device: CooperVision MiSight (omafilcon A/60%) Myopia Control one day Soft Contact Lens

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 Type: Interventional
• Enrollment (Estimated): 418
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Yan Zhang; Phone Number: +86 21 60327166; Email: Yan.Zhang1@bausch.com

Study Locations

• China
  • Beijing
    • Beijing, Beijing, China, 100044
      • Site 105
    • Dongcheng, Beijing, China, 100730
      • Site 107
  • Fujian
    • Xiamen, Fujian, China, 361004
      • Site 109
  • Hainan
    • Haikou, Hainan, China, 570311
      • Site 111
  • Hubei
    • Wuhan, Hubei, China, 430012
      • Site 110
  • Shanghai
    • Shanghai, Shanghai, China, 200433
      • Site 102
  • Shanxi
    • Taiyuan, Shanxi, China, 030072
      • Site 106
  • Shenzhen
    • Shenzhen, Shenzhen, China, 518040
      • Site 108
  • Sichaun Province
    • Chengdu, Sichaun Province, China, 610044
      • Site 103
  • Tianjin
    • Nankai, Tianjin, China, 300392
      • SITE 104
  • Zhejiang
    • Wenzhou, Zhejiang, China, 325027
      • Site 101

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Single Group Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Bausch + Lomb (kalifilcon A) Myopia Control Soft (Hydrophilic)	Device: Bausch + Lomb (kalifilcon A) Myopia Control Soft (Hydrophilic); Bausch + Lomb (kalifilcon A) Myopia Control Soft (Hydrophilic)
Active Comparator: CooperVision MiSight (omafilcon A/60%) Myopia Control one day Soft Contact Lens	Device: CooperVision MiSight (omafilcon A/60%) Myopia Control one day Soft Contact Lens; CooperVision MiSight (omafilcon A/60%) Myopia Control one day Soft Contact Lens

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Bausch & Lomb Incorporated

Study record dates

Study Major Dates

• Study Start (Estimated): March 29, 2024
• Primary Completion (Estimated): January 31, 2027
• Study Completion (Estimated): January 31, 2027

Study Registration Dates

• First Submitted: March 5, 2024
• First Submitted That Met QC Criteria: March 11, 2024
• First Posted (Actual): March 12, 2024

Study Record Updates

• Last Update Posted (Actual): March 12, 2024
• Last Update Submitted That Met QC Criteria: March 11, 2024
• Last Verified: March 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Eye Diseases; Refractive Errors; Myopia
• Other Study ID Numbers: 921

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No