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Tests treatment safety and results for Myopia
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
ClinicalTrials.gov ID: NCT06305663
What this study is testing
- What it's testing
- 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
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 8 to 12
You may be able to join if
- 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...
- Subject must meet the following determined by cycloplegic subjective refraction in both eyes at screening:
- Spherical Equivalent Refractive Error (SERE): between -0.75 D and -4.00 D, inclusive.
- Astigmatism: ≤ -0.75 D. c. Anisometropia: \< 1.00 D.
- Subject must be myopic and require lens correction from -0.75 D to -4.00 D, at screening, in each eye.
You likely can't join if
- Subject has previously worn, or currently wears rigid gas permeable contact lenses, including orthokeratology lenses.
- Current or prior use of bifocals, progressive addition lenses, multifocal soft contact lenses, atropine, pirenzepine or ANY other myopia control...
- Subject appears to exhibit poor personal hygiene (that in the Investigator's opinion might prevent safe contact lens wear).
- Per oral inquiry from parents/guardian, the subject was born earlier than 30 weeks or weighed less than 1,500 g at birth.
- Prior strabismus, intraocular, or refractive surgery.
- Subject using any systemic or local eye medication that interfere with the wearing of corneal contact lenses, pupil size, adjustment or refractive...
See the full eligibility criteria
- 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.
- Subject must meet the following determined by cycloplegic subjective refraction in both eyes at screening:
- Spherical Equivalent Refractive Error (SERE): between -0.75 D and -4.00 D, inclusive.
- Astigmatism: ≤ -0.75 D. c. Anisometropia: \< 1.00 D.
- Subject must be myopic and require lens correction from -0.75 D to -4.00 D, at screening, in each eye.
- 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.
- Subject and Parent or Guardian must be willing to participate in either the test or the comparator assignment.
- 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.
- Subject must have wearable and visually functioning eyeglasses.
- Subject must be in good general health according to their and parent's or guardian's knowledge
- Subject has previously worn, or currently wears rigid gas permeable contact lenses, including orthokeratology lenses.
- Current or prior use of bifocals, progressive addition lenses, multifocal soft contact lenses, atropine, pirenzepine or ANY other myopia control treatment.
- Subject appears to exhibit poor personal hygiene (that in the Investigator's opinion might prevent safe contact lens wear).
- Per oral inquiry from parents/guardian, the subject was born earlier than 30 weeks or weighed less than 1,500 g at birth.
- Prior strabismus, intraocular, or refractive surgery.
- 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".
- A known allergy to fluorescein, benoxinate, proparacaine, or cyclopentolate.
- A history of corneal hypoesthesia (reduced corneal sensitivity), corneal ulcer, corneal infiltrates, ocular viral or fungal infections or other recurrent ocular infections.
- Strabismus by cover test at far (4 m) or near (40 cm) wearing distance correction.
- 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.
- 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...
- Keratoconus or an irregular cornea.
- people with any Grade 2 or greater finding during the slit lamp examination, or people with any scar or neovascularization within the central 6 mm of the cornea, or people with corneal infiltrates, of ANY GRADE.
- people with any "present" finding during the slit lamp examination (biomicroscopy) that, in the investigator's judgment, interferes with contact lens wear. people with minor peripheral corneal scarring (that does not...
- The Investigator for any reason considers that it is not in the best interest of the Subject to participate in the study.
- people 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...
- Immediate family or close relative is a member of site study team members
The study team makes the final eligibility decision.
Where it's taking place
- Beijing, Beijing Municipality, China
- Dongcheng, Beijing Municipality, China
- Xiamen, Fujian, China
- Haikou, Hainan, China
- Wuhan, Hubei, China
- Shanghai, Shanghai Municipality, China
- Taiyuan, Shanxi, China
- Shenzhen, Shenzhen, China
- Chengdu, Sichaun Province, China
- Nankai, Tianjin Municipality, China
- Wenzhou, Zhejiang, China
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 8 years to 12 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Beijing, Beijing Municipality, China; Dongcheng, Beijing Municipality, China; Xiamen, Fujian, China; Haikou, Hainan, China; Wuhan, Hubei, China; Shanghai, Shanghai Municipality, China and 5 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.