Actively Recruiting
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
Led by Bausch & Lomb Incorporated · Updated on 2025-06-15
418
Participants Needed
11
Research Sites
148 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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
CONDITIONS
Official 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 capacity to provide informed consent
- Spherical Equivalent Refractive Error between -0.75 D and -4.00 D in both eyes
- Astigmatism of -0.75 D or less
- 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 assigned group
- Agreement to wear assigned contact lenses at least 10 hours per day, 6 days per week for 24 months
- Must have wearable and visually functioning eyeglasses
- Good general health according to participant and parent or guardian knowledge
You will not qualify if you...
- Previous or current use of rigid gas permeable lenses including orthokeratology
- Current or prior use of bifocals, progressive addition lenses, multifocal soft contacts, atropine, pirenzepine, or other myopia control treatments
- Poor personal hygiene that may prevent safe contact lens wear
- Born earlier than 30 weeks gestation or birth weight less than 1,500 g
- Prior strabismus, intraocular, or refractive surgery
- Use of systemic or local eye medications interfering with contact lens wear or refractive status
- Known allergy to fluorescein, benoxinate, proparacaine, or cyclopentolate
- History of corneal hypoesthesia, ulcer, infiltrates, ocular viral or fungal infections
- Strabismus at far or near with distance correction
- Known ocular or systemic diseases like uveitis, glaucoma, Sjögren's syndrome, lupus, scleroderma, or diabetes
- Ocular, systemic, or neurodevelopmental conditions affecting refractive development
- Keratoconus or irregular cornea
- Grade 2 or greater slit lamp findings or central corneal scars or neovascularization
- Any slit lamp finding interfering with contact lens wear
- Investigator judgment deeming participation not in best interest
- Participation in drug or device trials within 4 or 2 weeks prior to study
- Immediate family member is part of the site study team
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
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
CONTACT
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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