2023-503185-23-00已完成3 期
MULTICENTRE, RANDOMISED, DOUBLE-BLIND, VEHICLE AND ACTIVE-CONTROLLED PHASE III STUDY EVALUATING THE EFFICACY AND SAFETY OF KETOTIFEN OPHTHALMIC SOLUTION 0.5 MG/ML COMPARED TO VEHICLE AND KETOFTIL (KETOTIFEN OPHTHALMIC SOLUTION 0.5 MG/ML) FOR THE TREATMENT OF SEASONAL ALLERGIC CONJUNCTIVITIS.
Genetic S.p.A.8 个研究点 分布在 1 个国家目标入组 253 人开始时间: 2023年5月5日最近更新:
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 253
- 试验地点
- 8
- 主要终点
- To evaluate Ocular Itching between V1 (baseline) and V5 (14 days) later Ketotifen/ Ketoftil®/Placebo administrations. Ocular itching scores will be self-assessed by the participants using a 5-point scale.
研究概览
简要总结
MULTICENTRE, RANDOMISED, DOUBLE-BLIND, VEHICLE AND ACTIVE-CONTROLLED PHASE III STUDY EVALUATING THE EFFICACY AND SAFETY OF KETOTIFEN OPHTHALMIC SOLUTION 0.5 MG/ML COMPARED TO VEHICLE AND KETOFTIL (KETOTIFEN OPHTHALMIC SOLUTION 0.5 MG/ML) FOR THE TREATMENT OF SEASONAL ALLERGIC CONJUNCTIVITIS.
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
- •Adult patient (age from 18 to 65 years old).
- •Diagnosis of SAC assess through skin test and/or validated IgE radioallergosorbent test (RAST) to the relevant seasonal allergy for the geographic area within the past 12 months.
- •Experiencing symptoms or exceeding an appropriate minimum level of symptoms at the time of enrolment (Patients must have at least one of Redness, tearing, itchy eyes, eyelid swelling, conjunctival chemosis with a grade score of one)
- •Patient has given written informed consent approved by the Ethics Committee (EC).
排除标准
- •Diagnosis of any ocular pathology other than acute SAC (dry eye, chronic allergic conjunctivitis, VKC, viral or bacterial conjunctivitis).
- •Best corrected visual acuity (Snellen) in either eye worse than 20/
- •Patients who have received anti-allergy immunotherapy (desensitising subjects with increase of allergen challenges) in the previous two years or are still receiving this kind of therapy.
- •History of Hypersensitivity to other anti-allergic agents (including corticosteroids).
- •Use of non-steroidal anti-inflammatory agents, mast cell stabilizers, antihistamines, decongestants, or α-adrenoreceptor antagonists.
- •Use of topical (ocular) or systemic corticosteroids.
- •Any other medical condition that could have interfered with the results of the study.
- •History of Hypersensitivity related to the study IMPs, including any of the excipients.
- •Female of potential child-bearing that does not use at least one effective contraceptive method for the entire study.
- •Use of prostaglandin for Glaucoma treatments in the last 1 month.
- •Use of cyclosporine eyedrops for severe dry eye.
- •Female patient: pregnant, lactating or planning pregnancy within next 12 months (Female of child-bearing potential will undergo urine pregnancy test).
- •Participation in a clinical trial in which an investigational drug or device was administered in the 30 days prior to screening or 5 half-lives of the study drug, whichever is longer.
- •Patient legally or mentally incapacitated unable to give informed consent for the participation in this study.
- •Patient who is unable or unwilling to comply with the appointments or with all the requirements of the Protocol.
- •Use of contact lenses during the course of the study.
- •History of ocular surgery or laser within the previous 3 months.
结局指标
主要结局
To evaluate Ocular Itching between V1 (baseline) and V5 (14 days) later Ketotifen/ Ketoftil®/Placebo administrations. Ocular itching scores will be self-assessed by the participants using a 5-point scale.
To evaluate Ocular Itching between V1 (baseline) and V5 (14 days) later Ketotifen/ Ketoftil®/Placebo administrations. Ocular itching scores will be self-assessed by the participants using a 5-point scale.
次要结局
- To evaluate Conjunctival Redness at 30 minutes, 2 days, 7 days, 14 days later the first Ketotifen/Ketoftil®/Placebo administrations. Conjunctival redness will be assessed by the Investigator using the Efron scale.
- To evaluate tearing and eyelid swelling at 30 minutes, 2 days, 7 days, 14 days later the first Ketotifen/Ketoftil®/Placebo administrations. Tearing and eye swelling will be assessed by the Investigator using a 4-point scale
- To evaluate conjunctival chemosis at 30 minutes, 2 days, 7 days, 14 days later the first Ketotifen/Ketoftil®/Placebo administrations. Conjunctival chemosis will be assessed by the Investigator using a 3-point scale.
- To evaluate the product tolerability at 30 minutes, 2 days, 7 days, 14 days later the first Ketotifen/Ketoftil®/Placebo administrations. Product tolerability will be assessed by the Investigator using the Visual Analog Scale (VAS).
- 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 (8)
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