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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

모집중
임상시험 세부 정보는 주로 영어로 제공됩니다. 하지만 임상 레이더 AI가 도와드릴 수 있습니다! '임상시험 설명'를 클릭하여 선택한 언어로 임상시험 정보를 확인하고, 이에 대해 AI와 논의해 보세요.
임상시험 NCT06305663은(는) 근시에 대해 알아보는 중재연구입니다. 현재 상태는 모집중이며, 연구는 2024년 3월 29일에 시작되어 418명의 참여자를 모집하고 있습니다. Bausch & Lomb Incorporated이(가) 진행하며, 2027년 1월 31일까지 완료될 예정입니다. ClinicalTrials.gov의 가장 최근 정보는 2025년 6월 15일에 갱신되었습니다.
간단한 개요
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
상세한 설명
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
공식 제목

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

질환명
근시
기타 연구 식별자
  • 921
NCT 번호
NCT06305663
실제 연구 시작일
2024-03-29
최신 업데이트 게시
2025-06-15
예상 연구 완료일
2027-01-31
계획된 등록 인원
418
연구종류
중재연구
단계/상
해당 없음
상태
모집중
주요 목적
치료
설계 할당
무작위배정
중재 모델
단일군설계
맹검 (마스킹)
이중맹검
시험군 / 개입
참가자 그룹/시험군개입/치료
실험적Bausch + Lomb (kalifilcon A) Myopia Control Soft (Hydrophilic)
Bausch + Lomb (kalifilcon A) Myopia Control Soft (Hydrophilic)
Bausch + Lomb (kalifilcon A) Myopia Control Soft (Hydrophilic)
활성 대조군CooperVision 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
주요결과변수
결과변수측정값 설명시간 범위
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
참여 도우미
적격성 기준

연령대
어린이
최소 연령
8 Years
참여 가능한 성별
전체

  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
연구 대표 연락처
연락처: Yan Zhang, +86 21 60327166, [email protected]
11 1개국에 임상시험 장소

Beijing Municipality

Site 105, Beijing, Beijing Municipality, 100044, China
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Site 107, Dongcheng, Beijing Municipality, 100730, China
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Fujian

Site 109, Xiamen, Fujian, 361004, China
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Hainan

Site 111, Haikou, Hainan, 570311, China
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Hubei

Site 110, Wuhan, Hubei, 430012, China
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Shanghai Municipality

Site 102, Shanghai, Shanghai Municipality, 200433, China
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Shanxi

Site 106, Taiyuan, Shanxi, 030072, China
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Shenzhen

Site 108, Shenzhen, Shenzhen, 518040, China
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Sichaun Province

Site 103, Chengdu, Sichaun Province, 610044, China
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Tianjin Municipality

Site 104, Nankai, Tianjin Municipality, 300392, China
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Zhejiang

Site 101, Wenzhou, Zhejiang, 325027, China
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