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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 418

Recruiting
Clinical Trial NCT06305663 is an interventional study for Myopia that is recruiting. It started on 29 March 2024 with plans to enroll 418 participants. Led by Bausch & Lomb Incorporated, it is expected to complete by 31 January 2027. The latest data from ClinicalTrials.gov was last updated on 15 June 2025.
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
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

Conditions
Myopia
Other Study IDs
  • 921
NCT ID Number
NCT06305663
Start Date (Actual)
2024-03-29
Last Update Posted
2025-06-15
Completion Date (Estimated)
2027-01-31
Enrollment (Estimated)
418
Study Type
Interventional
PHASE
N/A
Status
Recruiting
Primary Purpose
Treatment
Design Allocation
Randomized
Interventional Model
Single Group
Masking
Double
Arms / Interventions
Participant Group/ArmIntervention/Treatment
ExperimentalBausch + Lomb (kalifilcon A) Myopia Control Soft (Hydrophilic)
Bausch + Lomb (kalifilcon A) Myopia Control Soft (Hydrophilic)
Bausch + Lomb (kalifilcon A) Myopia Control Soft (Hydrophilic)
Active ComparatorCooperVision MiSight (omafilcon A/60%) Myopia Control one day Soft Contact Lens
CooperVision MiSight (omafilcon A/60%) Myopia Control one day Soft Contact Lens
CooperVision MiSight (omafilcon A/60%) Myopia Control one day Soft Contact Lens
Primary Outcome Measures
Outcome MeasureMeasure DescriptionTime 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
Participation Assistant
Eligibility Criteria

Eligible Ages
Child
Minimum Age
8 Years
Eligible Sexes
All

  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

  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
Bausch & Lomb Incorporated logoBausch & Lomb Incorporated
Study Central Contact
Contact: Yan Zhang, +86 21 60327166, [email protected]
11 Study Locations in 1 Countries

Beijing Municipality

Site 105, Beijing, Beijing Municipality, 100044, China
Active, not recruiting
Site 107, Dongcheng, Beijing Municipality, 100730, China
Active, not recruiting

Fujian

Site 109, Xiamen, Fujian, 361004, China
Active, not recruiting

Hainan

Site 111, Haikou, Hainan, 570311, China
Active, not recruiting

Hubei

Site 110, Wuhan, Hubei, 430012, China
Active, not recruiting

Shanghai Municipality

Site 102, Shanghai, Shanghai Municipality, 200433, China
Active, not recruiting

Shanxi

Site 106, Taiyuan, Shanxi, 030072, China
Active, not recruiting

Shenzhen

Site 108, Shenzhen, Shenzhen, 518040, China
Active, not recruiting

Sichaun Province

Site 103, Chengdu, Sichaun Province, 610044, China
Active, not recruiting

Tianjin Municipality

Site 104, Nankai, Tianjin Municipality, 300392, China
Active, not recruiting

Zhejiang

Site 101, Wenzhou, Zhejiang, 325027, China
Recruiting