A multicenter, Investigator - masked, parallel-group, randomized study of the efficacy and safety of loteprednol etabonate 0.5% eyedrops versus dexamethasone 0.1% eyedrops in the treatment of ocular inflammation following cataract surgery. - Study#541-Lteprednol etabonate vs Dexamethasone

BAUSCH&LOMB0 个研究点目标入组 190 人开始时间: 2008年11月17日最近更新: 2012年4月3日

适应症

试验速览

暂无简介。

•Subjects enrolled in this study must satisfy the following inclusion criteria: 1. Must be of legal age (at least 18) and have full legal capacity to volunteer, 2. Must read, understand, and sign the IEC approved Informed Consent Form (ICF), and provide authorization as appropriate for local privacy regulations, 3. Must be scheduled to undergo cataract surgery in one eye, involving phacoemulsification with posterior chamber IOL implantation using topical anesthesia, 4. Females who are sexually active must fall into one of the following categories: Post menopausal Surgically sterile Currently using one of the following birth control methods throughout the duration of the study: -Intrauterine device (>14 days) -Barrier method (condom or diaphragm) with spermicide (>14 days) -Hormonal contraception (same dose and same formulation for at least six months 5. Women of childbearing potential who have a negative urine pregnancy test, 6. Must be willing to wait to undergo cataract surgery on the fellow eye until after the Visit 5 (Day 14 ±1 day) assessments have been completed. 7. Must be able and willing to comply with all treatment and follow up 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
•F.1.3 Elderly (>=65 years) yes
•F.1.3.1 Number of subjects for this age range

•Subjects enrolled in this study must not meet any of the following exclusion criteria: 1. Participating in any investigational drug or device study within 30 days prior to entry into this study, 2. Inflammatory and/or infectious pathology of the eye and its adnexa, 3. History of postoperative intraocular infection in the fellow eye, 4. Glaucoma in study eye, 5. Post-traumatic cataract in study eye, 6. Exfoliative syndrome, 7. Diabetes, 8. History of uveitis, 9. With any progressive pathology requiring the use of topical or systemic anti-inflammatory or anti-infectious agents, 10. Immunodepression, 11. A history of intolerance to the study drugs, to steroids or to NSAIDs, 12. Monocular (for any other reason than cataract), 13. Treated with local or systemic anti-inflammatory drugs within 10 days prior to inclusion in this study, 14. Currently taking glaucoma medications, cholinolytic drugs, cycloplegic or mydriatic agents (other than those required for the surgical procedure) 15. Currently taking oral anticoagulants, heparin, lithium, ticlopidine and high doses of methotrexate (≥ 15 mg/week), 16. Currently taking acetylsalicylic acid at doses > 300 mg/day, 17. Allergy to lidocaine, 18. Allergy to fluorescein, 19. Fellow eye previously enrolled in this study, 20. Women who are pregnant or breastfeeding

发起方

BAUSCH&LOMB