2023-504759-28-00招募中3 期
RANDOMIZED, OPEN LABEL, PARALLEL-GROUP, TWO-ARM, MULTICENTER STUDY WITH CLINICAL ENDPOINT COMPARING PRESERVATIVE FREE BIMATOPROST OPHTHALMIC SOLUTION 0.1 MG/ML AND LUMIGAN® (BIMATOPROST OPHTHALMIC SOLUTION) 0.1 MG/ML IN PATIENTS WITH CHRONIC OPEN-ANGLE GLAUCOMA OR OCULAR HYPERTENSION IN ONE OR BOTH EYES.
Genetic S.p.A.6 个研究点 分布在 1 个国家目标入组 124 人开始时间: 2024年2月14日最近更新:
适应症
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 发起方
- 入组人数
- 124
- 试验地点
- 6
- 主要终点
- Difference in intraocular pressure (IOP) of one eye, (if both eyes have been treated only the contralateral right eye will be chosen) between the two treatment groups of the mean percentage reduction from baseline (V2) to day 42 (V5).
研究概览
简要总结
To evaluate the efficacy, tolerability, and safety of Bimatoprost 0.1 mg/ml unit dose formulation compared to the reference Lumigan® in patients with Chronic Open Angle Glaucoma or Ocular Hypertension.
入排标准
- 年龄范围
- 18 years 至 65+ years（18-64 Years, 65+ Years）
- 接受健康志愿者
- 否
入选标准
- •Patients willing and able to provide voluntary informed consent and to follow protocol requirements.
- •Male or females aged ≥18 years
- •Patients with chronic open-angle glaucoma or ocular hypertension in one or both eyes.
- •Patients can switch ocular hypotensive medications and undergo appropriate washout period, under clinical Investigator’s discretion.
- •At Baseline IOP > 21 mm Hg and ≤ 35 mm Hg in one or both eyes.
- •At Baseline best corrected visual acuity (BCVA) equivalent to Snellen acuity of 20/200 or better in each eye.
排除标准
- •Female patient: pregnant, lactating or planning pregnancy within next 12 months (Female of child-bearing potential will undergo urine pregnancy test).
- •Use of contact lens within 1 week prior to baseline.
- •Use within 2 weeks prior to baseline of a topical ophthalmic corticosteroid.
- •Use within 1 month prior to baseline of a systemic corticosteroid.
- •Use within 6 months prior to baseline of intravitreal or subtenon injection of an ophthalmic corticosteroid.
- •Underwent within 6 months prior to baseline any other intraocular surgery (e.g., cataract surgery).
- •Underwent within 12 months prior to baseline any refractive surgery, filtering surgery, or laser surgery for IOP reduction (e.g., laser trabeculoplasty).
- •Patients with a history of IOP previously uncontrolled and stabilized on Bimatoprost monotherapy
- •Significant ocular surface findings (e.g., hyperaemia or irritation, moderate or greater) in either eye found on slit lamp examination.
- •Retinopathy
- •Chronic use of any systemic medication that may affect IOP with less than 3 months stable dosing regimen (i.e., sympathomimetic agents, beta-adrenergic blocking agents, alpha-agonists, alpha-adrenergic blocking agents, calcium channel blockers, angiotensin-converting enzyme inhibitors, etc.)
- •Female of potential child-bearing that does not use at least one effective contraceptive method for the entire study.
- •Central Corneal thickness (CCT) <450 microns or >650 microns.
- •Known history or presence of any uncontrolled systemic disease (e.g., cardiovascular disease, hypertension, diabetes mellitus, hepatic impairment, etc.)
- •History of recurrent ocular seasonal allergies within the past 2 years.
- •Any other medical condition or serious intercurrent illness that, in the Investigator's opinion, may make it undesirable for the patient to participate in the study and would limit adherence to the study requirements.
- •Participation in any clinical study within 90 days before the first dose of the study treatment.
- •Contraindication or known hypersensitivity to Bimatoprost, related class of drugs, or any of the excipients of formulation.
- •Current or history of severe hepatic or renal impairment.
- •Current or history within 2 months prior to baseline of any other significant ocular disease (e.g., corneal oedema, uveitis, ocular infection, or ocular trauma in either eye (Note: stable myopia, strabismus, and cataracts as per the Investigator's discretion will be allowed provided that the other inclusion/exclusion criteria are met).
- •Current corneal abnormalities that would prevent accurate IOP readings with Goldmann applanation tonometer.
- •Significant visual field defect (MD>15.0 dB)
- •Patients with corneal grafts.
- •Use at any time prior to baseline of an intraocular corticosteroid implant.
结局指标
主要结局
Difference in intraocular pressure (IOP) of one eye, (if both eyes have been treated only the contralateral right eye will be chosen) between the two treatment groups of the mean percentage reduction from baseline (V2) to day 42 (V5).
Difference in intraocular pressure (IOP) of one eye, (if both eyes have been treated only the contralateral right eye will be chosen) between the two treatment groups of the mean percentage reduction from baseline (V2) to day 42 (V5).
次要结局
- Efficacy: Reduction in IOP, at each follow-up time point, as compared with baseline, in the two study groups.
- Tolerability: Local tolerability assessed through Ocular Surface Disease Index (OSDI), Efron scale, Oxford scale, from baseline (V2) to day 42 (V5).
- Safety: Quantitative and Qualitative Evaluation of Safety in terms of adverse events reported.
研究者
Rocco Carmelo Pavese
Scientific
Genetic S.p.A.
研究点 (6)
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