An international, multicenter, randomized, blinded-assessor, parallel-group clinical study comparing eye drops of combined LEvofloxAcin + DExamethasone foR 7 days followed by dexamethasone alone for an additional 7 days vs. tobramycin + dexamethasone for 14 days for the prevention and treatment of inflammation and prevention of infection associated with cataract surgery in adults – LEADER 7. - LEADER 7

TC s.r.l.0 个研究点目标入组 800 人开始时间: 2018年6月21日最近更新: 2019年6月30日

适应症

试验速览

暂无简介。

•1. Signed written informed consent must be obtained before any assessment is performed
•2. Male or female, age =40 years
•3. Senile or presenile uncomplicated cataract surgery
•4. Willing to interrupt the use of contact lenses for the entire duration of the study
•5. Able and willing to follow study procedures
•6. Female patients must be postmenopausal (24 months of amenorrhea), surgically sterile or must agree to use an effective method of contraception, which include an established hormonal therapy or intrauterine device for females, and the use of a barrier contraceptive (i.e. diaphragm or condoms) with spermicide.
•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 200
•F.1.3 Elderly (>=65 years) yes
•F.1.3.1 Number of subjects for this age range 600

•1. Ocular conditions that at the discretion of the Investigator may interfere with the efficacy and/or safety evaluations (e.g. ocular herpes, blepharitis, conjunctivitis, uveitis, keratitis, diabetic retinopathy, retinal vein occlusions, retinal vasculitis, retinal angiomatous proliferation, pseudoexfoliation syndrome, intraoperative floppy iris syndrome, etc.)
•2. Patients undergoing bilateral cataract surgery
•3. Patients under treatment with prostaglandin analogues or intravitreal injections of anti-VEGF (vascular endothelial growth factor) drugs
•4. Systemic diseases that may interfere with the results of the study (e.g. rheumatoid arthritis, Sjögren's syndrome, Behçet's disease, systemic lupus erythematosus, scleroderma with major ocular involvement, etc.)
•5. Any condition that could interfere with correct instillation of eye drops
•6. Ocular surgery in the study eye (including laser surgery) in the 3 months before screening
•7. Monocular patients
•8. Visual Acuity (VA) < 20/80 in the contralateral eye
•9. Contraindication to ocular treatment with levofloxacin, tobramycin or dexamethasone
•10. Hypersensitivity to the study product or its excipients
•11. Participation in other studies in the last month before screening
•12. Pregnancy or breastfeeding

发起方

TC s.r.l.