AN OPEN LABEL, RANDOMIZED, MULTICENTRIC, TWOTREATMENT, SINGLE DOSE, PARALLEL GROUP TWO STAGEADAPTIVE DESIGN BIOEQUIVALENCE STUDY OF LOTEPREDNOLETABONATE OPHTHALMIC SUSPENSION, 0.5 % IN AQUEOUSHUMOR OF PATIENTS UNDERGOING INDICATED CATARACTSURGERY

Watson Pharma Pvt Ltd India0 个研究点目标入组 560 人开始时间: 待定最近更新: 2021年11月24日

试验速览

暂无简介。

•1. male or female 18 to 75 years of age, both ages inclusive
•2. Have presence of cataract in at least one eye indicated for extracapsular cataract
•extraction/phacoemulsification.
•3. Be patients with The Lens Opacities Classification System III (LOCS III
•classification).
•4. Body Mass Index between 18.0 and 30.0 kg/m2
•5. Be able to communicate effectively with the study personnel.
•6. Be a non-consumer (user) of tobacco (not consumed tobacco in the past 6
•months) or a mild or moderate consumer (user) of tobacco.
•7. Should have undergone medical screening.
•8. Have given the written informed consent for participation in the study.
•9. Be declared eligible to participate in the study by the investigator (s).

•1. Participation in a drug research study within past 3 months.
•2. Presence or history of epithelial herpes simplex keratitis, vaccinia, varicella of the cornea and conjunctiva.
•3. Recent or active viral diseases of the cornea and conjunctiva.
•4. Presence or history of uveitis or uveitis within the previous 12 months.
•5. Ocular trauma within 3 months of the trial, active external ocular disease, inflammation, or infection
•6. Received Loteprednol etabonate within 7 days of check-in.
•7. Uncontrolled diabetes.
•8. History of drug abuse or alcoholo dependence or abuse.
•9. History of any allergies
•10. Hypersensitivity to investgational product
•11. Extreme consumer of tobacco
•12. Presence of any clinically significant disorder.
•13. Clinical laboaratory values out side the accepatble range.
•14 Uncontrolled blood pressure.
•15. positive screening to Hepatitis B, Hepatitis C and HIV.
•16. Any clinically significant illness in past 4 weeks pror to check-in.
•17. Change in existing prescription drug (s) for systemic action or OTC drug in the
•14 days prior to check-in.
•18. Positive urine drug screening results for any of the following: cocaine, THC,
•barbiturates, amphetamines, benzodiazepines, and morphine.
•19 Positive test for pregnancy for female patients

发起方

Watson Pharma Pvt Ltd India