Aqueous humour concentrations after topical apPlication of combinEd levofloxacin dexamethasone eye dRops and of its single components: a randoMized, assEssor-blinded, parallel-group study in patients undergoing cataractsurgery - iPERME - iPERME

TC SR0 个研究点目标入组 120 人开始时间: 2020年7月13日最近更新: 2020年7月20日

试验速览

暂无简介。

•1. Written informed consent must be obtained before any assessment is performed
•2. Male or female patients, aged =40 years
•3. Patient undergoing phacoemulsification
•4. Corneal thickness between 450 µm and 600 µm as measured by means of pachymetry
•5. Corneal integrity confirmed by means of fluorescein test (Oxford scheme grade 0)
•6. Adequate pupil dilation assessed at screening
•7. Female patients of childbearing potential must have a negative pregnancy test
•8. Ability to fully understand all study procedures
•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 30
•F.1.3 Elderly (>=65 years) yes
•F.1.3.1 Number of subjects for this age range 90

•1. Corneal epithelium integrity not confirmed by fluorescein test
•2. History of corneal disease or dystrophy (e.g. ocular herpes, conjunctivitis, keratitis)
•3. History of ocular trauma with corneal damage
•4. History of acute ocular inflammation (including uveitis) in the 6 months prior to screening
•5. Previous ocular surgery (including laser treatment)
•6. Glaucoma
•7. Treatment with an ophthalmic investigational drug in the 3 months prior to screening
•8. Treatment with any topical ocular drug within 12 hours before start of cataract surgery other than study drugs and instillation of topical anaesthetic (oxybuprocaine hydrochloride - Novesina®) followed by povidone-iodine (Oftasteril®) within 10 minutes before start of surgery
•9. Treatment with any topical steroid or antibiotic drug in the 7 days prior to cataract surgery (artificial tears without BAK are allowed)
•10. Treatment with any systemic steroid or antibiotic drug in the 7 days prior to cataract surgery
•11. Known hypersensitivity to levofloxacin, other fluoroquinolones or dexamethasone
•12. Pregnant or lactating women
•13. Patients who have received any investigational drug during the preceding 30 days or 5 times the plasma half-life, whichever is longer, or who have previously participated in this trial

发起方

TC SR