Actively Recruiting
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
Led by Bausch & Lomb Incorporated · Updated on 2025-06-15
418
Participants Needed
11
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
This research aims to evaluate the safety and effectiveness of the Bausch + Lomb Myopia Control Lens in correcting myopia (nearsightedness) and slowing its progression in children aged 8 to 12 years. The study is a multi-center, randomized, parallel, bilateral, investigator-masked trial comparing this new lens to an active comparator lens, the CooperVision MiSight, to better understand options for managing myopia in this age group. Participants will be randomly assigned to wear either the Bausch + Lomb Myopia Control Soft Hydrophilic lens or the CooperVision MiSight one-day soft contact lens. Both interventions are designed for controlling myopia progression. The study involves wearing the assigned lenses daily for a minimum of 10 hours at least six days per week over a 24-month period. The trial is conducted with masking to reduce bias and ensure objective assessment. Children enrolled in the study will undergo various eye tests including measurements of axial length and spherical equivalent refractive error at baseline and after 1 and 2 years to track changes. Researchers will also monitor visual acuity and eye health throughout the study. The total participation duration is 24 months, with scheduled visits for evaluations and safety monitoring to assess the lenses' impact on myopia progression and eye health.
CONDITIONS
Brief Title
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
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Male or female aged 8 to 12 years plus 11 months with ability to provide informed assent and with parental or guardian consent
- Myopia requiring lens correction between -0.75 D and -4.00 D in each eye
- Astigmatism less than or equal to -0.75 D
- Anisometropia less than 1.00 D
- Distance best-spectacle corrected visual acuity of +0.04 logMAR (20/20) or better in each eye
- Willingness of subject and parent or guardian to participate in either study lens group
- Agreement to wear assigned contact lenses at least 10 hours per day, 6 days per week, for 24 months
- Possession of wearable and visually functioning eyeglasses
- Good general health as known by subject and parent or guardian
You will not qualify if you...
- Previous or current use of rigid gas permeable contact lenses including orthokeratology
- Current or prior use of bifocals, progressive addition lenses, multifocal soft contact lenses, atropine, pirenzepine, or any other myopia control treatments
- Poor personal hygiene that may prevent safe contact lens wear
- Born earlier than 30 weeks gestation or weighing less than 1,500 g at birth
- History of strabismus, intraocular, or refractive surgery
- Use of systemic or local eye medications that interfere with contact lens wear or affect pupil size or refractive status
- Known allergy to fluorescein, benoxinate, proparacaine, or cyclopentolate
- History of corneal hypoesthesia, corneal ulcer, corneal infiltrates, ocular viral or fungal infections, or recurrent ocular infections
- Strabismus by cover test at far or near with distance correction
- Known ocular or systemic diseases such as anterior uveitis, glaucoma, Sjögren's syndrome, lupus, scleroderma, or diabetes
- Ocular, systemic, or neurodevelopmental conditions affecting refractive development
- Keratoconus or irregular cornea
- Any Grade 2 or higher slit lamp examination findings or central corneal scars or neovascularization
- Any slit lamp findings interfering with contact lens wear
- Investigator's judgment that participation is not in the subject's best interest
- Participation in other drug or device clinical investigations within specified prior timeframes
- Immediate family or close relative is a member of the study site team
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 24 months
Participants wear assigned myopia control contact lenses for correction and slowing the progression of myopia.
Regular visits to monitor eye health and vision
Trial Site Locations
Total: 11 locations
1
Site 105
Beijing, Beijing Municipality, China, 100044
Active, Not Recruiting
2
Site 107
Dongcheng, Beijing Municipality, China, 100730
Active, Not Recruiting
3
Site 109
Xiamen, Fujian, China, 361004
Active, Not Recruiting
4
Site 111
Haikou, Hainan, China, 570311
Active, Not Recruiting
5
Site 110
Wuhan, Hubei, China, 430012
Active, Not Recruiting
6
Site 102
Shanghai, Shanghai Municipality, China, 200433
Active, Not Recruiting
7
Site 106
Taiyuan, Shanxi, China, 030072
Active, Not Recruiting
8
Site 108
Shenzhen, Shenzhen, China, 518040
Active, Not Recruiting
9
Site 103
Chengdu, Sichaun Province, China, 610044
Active, Not Recruiting
10
Site 104
Nankai, Tianjin Municipality, China, 300392
Active, Not Recruiting
11
Site 101
Wenzhou, Zhejiang, China, 325027
Actively Recruiting
Research Team
Y
Yan Zhang
How is the study designed?
Study Type
INTERVENTIONAL
Masking
DOUBLE
Allocation
RANDOMIZED
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
2
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