A Multi Center, Open Label, Randomized, Two-Treatment, Two-Sequence, Single Period, Parallel,Single Dose, Bioequivalence Study To Compare The Pharmacokinetics Of Marketed Product TobraDex® (Tobramycin And DexamethasoneOphthalmic Suspension) To An Experimental Ophthalmic Sterile Suspension Containing Tobramycin 0.3% And Dexamethasone 0.1% W/V In Aqueous Humor In Patients Undergoing Indicated Cataract Surgery.

Zumanta Pharmaceuticals LLC0 个研究点目标入组 552 人开始时间: 待定最近更新: 2021年11月24日

试验速览

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•a.Be male or female 18 to 55 years of age
•b.Presence of cataract in both the eyes and indicated for extracapsular cataract extraction
•e.Be able to communicate effectively with the study personnel
•h.Be medically fit with clinically acceptable laboratory profiles, ECG
•j.Be declared eligible to participate in the study by the investigator

•a.Participation in any bioavailability/bioequivalence/Pharmacokinetic study or received an investigational drug within a period of 3 months prior to check in
•b.Presence or history of epithelial herpes simplex keratitis (dendritic keratitis), vaccinia, varicella of the cornea and conjunctiva
•c.History of ?recent (last 15 days)? or ?active? viral diseases of the cornea and conjunctiva
•e.Ocular trauma within 3 months of the trial, active external ocular disease, inflammation, or infection (mycobacterial or fungal disease) of the study eye and corneal diseases or disruption
•m.Patients who have:
•i.Systolic blood pressure less than 90 mm of Hg or more than 140 mm of Hg. Diastolic blood pressure less than 60 mm of Hg or more than 90 mm of Hg. Minor deviations (2-4 mm of Hg) at check-in may be acceptable at the discretion of the physician /investigator (s).
•ii.Pulse rate below 60 per minute or above 100 per minute.
•iii.Respiratory rate below 15 or above 20 breaths per minute.
•iv.Oral temperature less than 96.2oF or more than 99.8oF

发起方

Zumanta Pharmaceuticals LLC