EUCTR2017-000846-23-IT进行中（未招募）1 期
Efficacy and safety assessment of T4032 (unpreserved bimatoprost 0.01%) versus Lumigan® 0.01% in ocular hypertensive or glaucomatous patients. - In-SIGHT study
ABORATOIRES THEA0 个研究点目标入组 434 人开始时间: 2021年1月21日最近更新:
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 434
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •At Screening Visit (D-42):
- •-Informed consent signed and dated.
- •-Patient aged =18 years old.
- •-Both eyes with 500 µm = central corneal thickness = 600 µm.
- •-Both eyes with diagnosed open-angle glaucoma or ocular hypertension, initially treated and controlled (including IOP = 18 mmHg) for at least 6 months by any prostaglandin monotherapy.
- •-Both eyes with IOP = 18 mmHg.
- •At Randomisation Visit (D1) at 8:00:
- •-Both eyes with 22 mmHg = IOP < 34 mmHg and with asymmetry between eyes = 3 mmHg.
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 161
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 273
排除标准
- •Ophthalmic Exclusion Criteria in AT LEAST ONE EYE:
- •2.1.1 Fundus examination not performed or not available within 12 months.
- •2.1.2 Visual field not performed or not available within 12 months.
- •2.1.3 Significant worsening according to the two last visual fields (at least 6 months between the two visual fields).
- •2.1.4 Advance stage of glaucoma, defined by at least one of the following criteria:
- •2.1.4.1 Absolute defect in the ten degrees central point of the visual field.
- •2.1.4.2 Severe visual field loss: MD < -18 dB.
- •2.1.4.3 Risk of visual field worsening as a consequence of participation in the study according to the investigator’s best judgement.
- •2.1.5 History of non-responder to bimatoprost therapy.
- •2.1.6 Far Best Corrected Visual Acuity = + 0.7 Log Mar (e.g., = 0.2 in decimal value or = 20/100 Snellen equivalent or = 50 ETDRS letters).
- •2.1.7 History of trauma, infection, clinically significant inflammation within the 3 previous months.
- •2.1.8 Ongoing or known history of ocular allergy and/or uveitis and/or viral infection.
- •2.1.9 Clinically significant or progressive retinal disease (e.g. retinal degeneration, diabetic retinopathy, retinal detachment).
- •2.1.10 Presence of at least one severe objective sign among the following:
- •2.1.10.1 Conjunctival hyperaemia (Grade 5 / McMonnies scale).
- •2.1.10.2 Superficial punctate keratitis (Grade 4/5 / Oxford scale).
- •-2.1.10.3 Blepharitis (Grade 3 / 0-3 scale).
- •2.1.11 Severe dry eye as assessed by the investigator.
- •2.1.12 Corneal ulceration.
- •2.1.13 Any palpebral abnormality incompatible with a good
- •examination.
- •2.1.14 Any other abnormality preventing accurate assessment e.g. reliable tonometry measurement, visual field examination, fundus examination.
- •Regarding Systemic/non Ophthalmic Exclusion Criteria, Specific Exclusion Criteria Regarding Childbearing Potential Women, Exclusion Criteria Related to General Conditions and Exclusion Criteria Related to Previous and Concomitant Treatments (Medications/Non-Medicinal Therapies/Procedures) please refer to the study protocol in page 30.
研究者
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