EUCTR2008-004336-20-FR进行中（未招募）不适用
Azithromycin concentration into aqueous humor of patients undergoing cataract surgery, after 3 days of treatment by AZYTER ® Open randomised monocentre study with 2 groups of 15 patients
aboratoires Thea0 个研究点目标入组 30 人开始时间: 2008年8月1日最近更新:
适应症
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 30
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 will be eligible for inclusion if all these criteria are respected:
- •- Male or female from 18 to 90 years old
- •- Signed and dated informed consent.
- •- Senile or pre-senile uncomplicated cataract.
- •- Scheduled to undergo cataract surgery
- •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
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range
排除标准
- •Patients fulfilling at the inclusion visit ONE OR MORE of the following non inclusion criteria will not be included in the study:
- •Ophthalmic non-inclusion criteria (in either eye)
- •None of the following criteria IN EITHER EYE:
- •- Surgical conditions in the eye to be operated:
- •ÿ Combined surgery.
- •ÿ Other cataract aetiologies than senile or pre-senile cataract.
- •- Non-surgical conditions in the eye to be operated:
- •ÿ Dacryocystitis and all others pathologies of tears drainage system.
- •ÿ Inflammatory ocular disease (uveitis, herpetic keratitis).
- •ÿ Corneal, epithelial, stromal or endothelial, residual or evolutionary disease (including corneal ulceration and superficial punctuate keratitis).
- •ÿ History of ocular traumatism, infection or inflammation within the last 3 months.
- •- Ophthalmic condition in the contra lateral eye:
- •ÿ Best corrected visual acuity < 1/10.
- •ÿ Patient already included in the study for phakoexeresis.
- •ÿ History of surgical complication
- •- Ophthalmic condition in either eye:
- •ÿ Presence of glaucoma and/or ocular hypertension history
- •9.3.2.2 Systemic/non ophthalmic non-inclusion criteria [2.2]
- •None of the following criteria:
- •- General history:
- •ÿ Diabetes not controlled,
- •ÿ Infectious diseases,
- •ÿ Immunosuppressive diseases,
- •ÿ Any other medical or surgical history, disorder or disease such as acute or chronic severe organic disease: hepatic, endocrine neoplasic, haematological diseases, severe psychiatric illness, relevant cardiovascular abnormalities, etc... and/or any complicating factor or structural abnormality judged by the investigator to be incompatible with the study.
- •- Allergic history:
- •ÿ Known hypersensitivity to one of the components of the study medications or to any other macrolide antibiotic or to test products,
- •ÿ Allergic rhinitis.
- •Specific non-inclusion criteria for women
- •- Pregnancy, lactation.
- •- Women without an effective method of contraception (oral contraceptive, intra-uterine device, subcutaneous contraceptive implant, patch).
- •- Women not hysterectomised, menopaused or surgically sterilized.
- •Non-inclusion criteria related to general conditions
- •- Inability of patient and/or relatives to understand the study procedures and thus inability to give informed consent
- •- Non compliant patient and/or relatives (e.g. not willing to attend the follow-up visits, way of life interfering with compliance).
- •- Participation in another clinical study.
- •- Already included once in this study.
- •- Ward of court.
- •- Patient not covered by the Social Security scheme.
- •Non-inclusion criteria related to previous and concomitant medications / non-product therapies
- •Patient using any of the following previous and concomitant medication / treatment (according to the described periods) will not be included in the study:
- •-4 weeks before the surgey date:
- •Systemic therapies: corticoid ans immunosuppressive treatment
- •Systemic azythromycin
- •-15 days before the surgery
- •Other systemic antibiotic
- •Topical ocular therapy in the eye to be operated other than tears substitutes (antibiotic, corticoid, antiallergic, antiseptic,....) (exept for antiseptic,
- •-7 days before for contact lenses
- •-3 days before for tear substitutes
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