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
- Conditions
- Patient concerned by this trial are patients who will undergo a cataract surgery
- Registration Number
- EUCTR2008-004336-20-FR
- Lead Sponsor
- aboratoires Thea
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Authorised-recruitment may be ongoing or finished
- Sex
- All
- Target Recruitment
- 30
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
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).
or
- 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
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: In this study, the primary objective will be the measurement of the concentration of azithromycin in aqueous humour into the operated eye of patient undergoing cataract surgery;Secondary Objective: ;Primary end point(s):
- Secondary Outcome Measures
Name Time Method