EUCTR2019-000747-27-IT进行中（未招募）1 期
A Multicenter, Randomized, Double-Masked, Placebo-Controlled Phase II Study to evaluate the Safety and Efficacy of Pro-ocular™ 0.5% and 1% in Patients with Dry Eye Syndrome - ProGIFT
SOCIETÀ INDUSTRIA FARMACEUTICA ITALIANA (SIFI) SPA0 个研究点目标入组 105 人开始时间: 2020年10月7日最近更新:
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 105
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
- •- Patients (male or female) must be >= 18 years of age
- •- Able and willing to provide voluntary written Informed Consent prior to any study related procedure
- •- Patients must be diagnosed with any type of dry eye at least 3 months before screening (Visit 0)
- •- Have all the following in the same eye at Visit 0: Fluorescein staining (Cornea) on NEI (National Eye Institute) grading scale > 3; Average Tear Film Break up Time =< 5 seconds; Schirmer Test (without anesthesia) >= 1 and < 10mm
- •- Be able and willing to follow instructions, including participation in all study assessments and visits, according to the opinion of the investigator.
- •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 50
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 55
排除标准
- •- Comorbidity with other severe or chronic eye conditions that in the judgment of the investigator will interfere with study assessment, such as such as glaucoma, active neuronal trigeminal disease, neuralgia
- •- Best corrected visual acuity (BCVA) baseline <20/200
- •- Condition or history other than ocular that, in the opinion of the investigator, may interfere significantly with the patient's participation in the study, such as dementia, psychosis, Parkinson’s disease (interference)
- •- Patient using a contact ocular lens within 7 days prior to administration of the first dose and not willing to cease using them during all study duration
- •- Female patients who are pregnant, nursing an infant, or planning a pregnancy or lactating at Screening Visit
- •- Females who are of childbearing potential and not taking adequate contraceptive precautions are excluded from the trial. Females of childbearing potential taking acceptable non-hormonal contraceptive precautions can be included
- •- Males with partners who are pregnant or lactating or of childbearing potential and are unwilling to use condoms for the duration of the study
- •- A known adverse reaction and/or sensitivity to the study drug or its components
- •- Use of topical ocular cyclosporine, corticosteroids or any other topical anti-inflammatory treatments within 15 days prior to Visit 0 and during all study duration
- •- Routine use (more than twice a week) of a chlorinated swimming pool during the study period
- •- Unwilling or unable to cease using during the study period the forbidden medications: any topical ocular ointments or gels; topical and systemic glaucoma therapies; systemic drugs with anticholinergic activity: anticonvulsants, antihistamines, antipsychotics, antidepressants, antimuscarinics, anti-Parkinson agents, cardiovascular agents (disopyramide), gastrointestinal agents, muscle relaxants, respiratory medications (pseudoephedrine, theophylline); lipidic artificial tears and artificial tears with preservative
- •- Unwilling to cease the use of sunscreen on the forehead or eye area during the study period
- •- Habitual cigarette smokers (tobacco, vapor cigarettes, marijuana), smoking more than 4 cigarettes per day
- •- Participation in another clinical study at the same time as the present and within 30 days prior to Visit 0.
研究者
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