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临床试验/NCT05243836
NCT05243836进行中（未招募）不适用

Contact Lenses Utilising S.T.O.P.® Technology Versus Dual-focus Contact Lenses for Slowing Down Myopia Progression in Children: A Three-year Prospective, Multi-centre, Controlled, Masked, Randomised, Non Inferiority Clinical Trial

nthalmic Pty Ltd7 个研究点 分布在 3 个国家目标入组 441 人开始时间: 2023年8月4日最近更新:
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适应症
干预措施

试验速览

阶段
不适用
状态
进行中（未招募）
入组人数
441
试验地点
7
主要终点
Axial Length
研究概览研究设计入排标准研究组 & 干预措施结局指标研究者研究点记录与标识符相似试验

研究概览

简要总结

To compare the rate of myopia progression of contact lenses utilising S.T.O.P.® technology against MiSight® contact lenses.

详细描述

Myopic children (8-14 years of age) will be randomly allocated to wear one of 3 contact lens options (MiSight®, S.T.O.P.®- F2 or S.T.O.P.®- DT) bilaterally on a daily wear basis. The overall trial duration, including follow-up period, is expected to be approximately 48 months. Each participant's duration is expected to be approximately 36 months.

The visits are Baseline / Fit, Dispensing, 1 week, 1 month, 6 months then visits every 6 months after.

All procedures performed at these visits are standard, non invasive clinical tests.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Prevention
盲法
Single (Investigator)

入排标准

年龄范围
8 Years 至 14 Years（Child）
性别
All
接受健康志愿者
否

入选标准

  • •Be between 8-
  • •Read the Informed Assent.
  • •Been explained the Informed Assent.
  • •Indicated an understanding of the Informed Assent.
  • •Signed the Informed Assent.
  • •Have their parent / legal guardian:
  • •Read the Informed Consent.
  • •Been explained the Informed Consent.
  • •Indicated an understanding of the Informed Consent.
  • •Signed the Informed Consent.
  • •Along with their parent / legal guardian, be capable of comprehending the nature of the study, and be willing and able to adhere to study requirements.
  • •Along with their parent / legal guardian, agree to maintain the visit schedule .
  • •Agree to wear allocated contact lenses for a minimum of 5 days per week, at least 6 hours per day on days lenses are worn but not > 16 hours per day, and to remove lenses at night (i.e., daily wear only with no contact lens wear during sleep), for their duration of the study and to inform the investigator if their schedule is interrupted. Wearing time can be modified by the investigator for health reasons.
  • •Possess wearable and visually functioning spectacles.
  • •Be in good general health, based on the parent's / legal guardian's knowledge.
  • •Have best-corrected high contrast visual acuity based on manifest refraction of 0.10 logMAR (20/25, 6/7.6) or better in each eye.
  • •Meet the following criteria determined by cycloplegic autorefraction:
  • •Spherical equivalent between -0.75 to -4.00 D inclusive.
  • •Astigmatism ≥ -1.00 D.
  • •*participants who fail astigmatism criterion with autorefraction pass astigmatism criterion if ≥ -0.75 D is measured with subjective refraction.
  • •anisometropia ≤ 1.00 D.

排除标准

  • •Participant is currently, or within 30 days prior to this study, has been an active participant in another study.
  • •Current or prior use of ANY form of myopia control, including but not limited to:
  • •Optical devices.
  • •Bifocal / multifocal spectacles of any type.
  • •Bifocal / multifocal contact lenses of any type.
  • •Orthokeratology of any type.
  • •Pharmacological agents.
  • •European and Indian sites: Atropine.
  • •Chinese sites: Atropine with a concentration > 0.01%. Participants who have previously used 0.01% atropine are eligible for this study provided they agree not to use 0.01% atropine for at least 30 days before baseline and at any time during the study.
  • •Pirenzepine.
  • •Participant born earlier than 30 weeks or weighed < 1500 g at birth.
  • •Habitual use of a systemic or topical medication that may alter normal ocular findings / is known to affect a participant's ocular health / physiology or contact lens performance either in an adverse or beneficial manner at enrolment and / or during the clinical trial.
  • •A known allergy to sodium fluorescein, benoxinate, proparacaine, or tropicamide.
  • •Chinese sites: A known allergy to cyclopentolate.
  • •A known corneal hypoesthesia (reduced corneal sensitivity), corneal ulcer, corneal infiltrates, ocular viral or fungal infections, or any other recurrent ocular infections.
  • •Strabismus by cover test at distance (3 m) or near (40 cm) while wearing distance correction under non-cycloplegic conditions.
  • •Known ocular or systemic disease, such as but not limited to:
  • •Diabetes.
  • •Graves' disease.
  • •Glaucoma.
  • •Scleritis.
  • •Auto-immune diseases such as ankylosing spondylitis, multiple sclerosis, Sjogrens syndrome, and systemic lupus erythematosus.
  • •Any ocular, systemic, or neuro-developmental conditions that could influence refractive development, such as but not limited to:
  • •Persistent pupillary membrane.
  • •Vitreous haemorrhage.
  • •Cataract.
  • •Central corneal scarring.
  • •Eyelid haemangiomas.
  • •Marfan's syndrome.
  • •Down's syndrome.
  • •Ehler's-Danlos syndrome.
  • •Stickler's syndrome.
  • •Ocular albinism.
  • •Retinopathy of prematurity.
  • •Keratoconus or irregular cornea.
  • •Biomicroscopic that contraindicate contact lens, such as but limited to:
  • •Neovascularisation or ghost vessels ≥ 1.5 mm in from limbus.
  • •Any active anterior segment disease that contraindicates safe contact lens wear.
  • •Clinically significant giant papillary conjunctivitis.
  • •Clinically significant abnormalities of the anterior segment, lids, conjunctiva, sclera, or associated structures.
  • •Allergic or seasonal conjunctivitis if the investigator believes it could significantly interfere with maintaining a specified wearing schedule.
  • •The investigator may, at their discretion, exclude anyone who they believe may not be able to fulfil the clinical trial requirements or it is believed to be in the participant's best interests.

研究组 & 干预措施

MiSight®

Active Comparator

MiSight® Contact Lens (Omafilcon A, 60% water)

干预措施: MiSight® (Device)

S.T.O.P® F2

Experimental

S.T.O.P® F2 Contact Lens (Ocufilcon D, 55% water)

干预措施: S.T.O.P® F2 (Device)

S.T.O.P® DT

Experimental

S.T.O.P® DT Contact Lens (Ocufilcon D, 55% water)

干预措施: S.T.O.P® DT (Device)

结局指标

主要结局

Axial Length

时间窗: Baseline, 1 month, 6 months, 12 months, 18 months , 24 months, 30 months, 36 months

Difference in change from baseline in axial length between test and control contact lenses.

Cycloplegic spherical equivalent autorefraction

时间窗: Baseline, 12 months, 24 months, 36 months

Difference in change from baseline in spherical equivalent autorefraction between test and control contact lenses.

次要结局

  • Bulbar hyperemia graded on a 0-4 scale in 0.5- steps where a higher grading indicates increased hyperemia(1 week, 1 month, 6 months, 12 months, 18 months , 24 months, 30 months, 36 months)
  • Binocular vision as measured by monocular accommodative facility (+/-2.00 D flipper) in cycles per minute at 40 cm(1 week, 6 months, 18 months, 30 months)
  • Visual performance as measured by high contrast visual acuity at 6 m(1 week, 1 month, 6 months, 12 months, 18 months , 24 months, 30 months, 36 months)
  • Cycloplegic spherical equivalent autorefraction(Baseline, 12 months, 24 months, 36 months)
  • Limbal hyperemia graded on a 0-4 scale in 0.5- steps where a higher grading indicates increased hyperemia(1 week, 1 month, 6 months, 12 months, 18 months , 24 months, 30 months, 36 months)
  • Binocular vision as measured by heterophoria in prism diopters at 40 cm(1 week, 6 months, 18 months, 30 months)
  • Corneal topography as measured by steep keratometry measurement in diopters(Baseline, 12 months, 36 months)
  • Visual performance as measured by a non validated questionnaire based on a 1-10 numeric rating scale where a higher score indicates a better outcome(1 week, 1 month, 6 months, 12 months, 18 months , 24 months, 30 months, 36 months)
  • Binocular vision as measured by heterophoria in prism diopters at 3 m(1 week, 6 months, 18 months, 30 months)
  • Binocular vision as measured by monocular accommodative response in diopters at 40 cm(1 week, 6 months, 18 months, 30 months)
  • Corneal topography as measured by flat keratometry measurement in diopters(Baseline, 12 months, 36 months)
  • Palpebral roughness graded on a 0-4 scale in 0.5- steps where a higher grading indicates increased roughness(1 week, 1 month, 6 months, 12 months, 18 months , 24 months, 30 months, 36 months)
  • Corneal staining graded on a 0-4 scale in 0.5- steps where a higher grading indicates increased staining(1 week, 1 month, 6 months, 12 months, 18 months , 24 months, 30 months, 36 months)
  • Conjunctival staining graded on a 0-4 scale in 0.5- steps where a higher grading indicates increased staining(1 week, 1 month, 6 months, 12 months, 18 months , 24 months, 30 months, 36 months)
  • Visual performance as measured by high contrast visual acuity at 6 m(Baseline, 1 week, 1 month, 6 months, 12 months, 18 months , 24 months, 30 months, 36 months)
  • Bulbar hyperemia graded on a 0-4 scale in 0.5- steps where a higher grading indicates increased hyperemia(Baseline, 1 week, 1 month, 6 months, 12 months, 18 months , 24 months, 30 months, 36 months)
  • Limbal hyperemia graded on a 0-4 scale in 0.5- steps where a higher grading indicates increased hyperemia(Baseline, 1 week, 1 month, 6 months, 12 months, 18 months , 24 months, 30 months, 36 months)
  • Palpebral roughness graded on a 0-4 scale in 0.5- steps where a higher grading indicates increased roughness(Baseline, 1 week, 1 month, 6 months, 12 months, 18 months , 24 months, 30 months, 36 months)
  • Corneal staining graded on a 0-4 scale in 0.5- steps where a higher grading indicates increased staining(Baseline, 1 week, 1 month, 6 months, 12 months, 18 months , 24 months, 30 months, 36 months)
  • Conjunctival staining graded on a 0-4 scale in 0.5- steps where a higher grading indicates increased staining(Baseline, 1 week, 1 month, 6 months, 12 months, 18 months , 24 months, 30 months, 36 months)
  • Corneal oedema graded on a 0-4 scale in 0.5- steps where a higher grading indicates increased oedema(Baseline, 1 week, 1 month, 6 months, 12 months, 18 months , 24 months, 30 months, 36 months)
  • Corneal striae graded on a 0-4 scale in 0.5- steps where a higher grading indicates increased striae(Baseline, 1 week, 1 month, 6 months, 12 months, 18 months , 24 months, 30 months, 36 months)
  • Meibomian gland dysfunction (MGD) graded on a 0-4 scale in 0.5- steps where a higher grading indicates increased MGD(Baseline, 1 week, 1 month, 6 months, 12 months, 18 months , 24 months, 30 months, 36 months)
  • Corneal neovascularization graded on a 0-4 scale in 0.5- steps where a higher grading indicates increased staining(Baseline, 1 week, 1 month, 6 months, 12 months, 18 months , 24 months, 30 months, 36 months)
  • Corneal epithelial microcysts graded on a 0-4 scale in 0.5- steps where a higher grading indicates increased staining(Baseline, 1 week, 1 month, 6 months, 12 months, 18 months , 24 months, 30 months, 36 months)
  • Contact lens surface characteristics staining graded on a 0-4 scale in 0.5- steps where a higher grading indicates worse contact lens surface characteristic.(Baseline, 1 week, 1 month, 6 months, 12 months, 18 months , 24 months, 30 months, 36 months)
  • Contact lens centration measured in mm(Baseline, 1 week, 1 month, 6 months, 12 months, 18 months , 24 months, 30 months, 36 months)
  • Contact lens primary gaze movement centration measured in mm where a higher value indicates increased movement in primary gaze(Baseline, 1 week, 1 month, 6 months, 12 months, 18 months , 24 months, 30 months, 36 months)
  • Contact lens primary gaze lag centration measured in mm where a higher value indicates increased lag.(Baseline, 1 week, 1 month, 6 months, 12 months, 18 months , 24 months, 30 months, 36 months)
  • Contact lens tightness measured as percentage where a higher percentage indicates a tighter lens(Baseline, 1 week, 1 month, 6 months, 12 months, 18 months , 24 months, 30 months, 36 months)

研究者

申办方类型
Network
责任方
Sponsor

研究点 (7)

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