Patient concerned by this trial are patients who will undergo a cataract surgery
Conditions
Interventions
Trade Name: AZYTER
Pharmaceutical Form: Eye drops, solution
Sponsors
Laboratoires Thea
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 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
Exclusion criteria
Exclusion criteria: 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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): | — |
Countries
France
Outcome results
None listed