A Comparative, Randomized, Double Blind, Multicentric, Prospective Clinical Study to Evaluate the Efficacy, Safety and Tolerability of Moxifloxacin Hydrochloride 0.5% + Difluprednate 0.05% Ophthalmic Solution Vs Moxifloxacin Hydrochloride 0.5% + Dexamethasone Phosphate 0.1% Eye Drops indicated in patients for Steroid Responsive Inflammatory Ocular Conditions for which a corticosteroid is indicated and where bacterial infection or a risk of bacterial ocular infection exists.

Ajanta Pharma Ltd0 个研究点目标入组 200 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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•1. Patients with endogenous anterior uveitis (including panuveitis)
•2. Patients with 20 or more anterior chamber cell within one field of the aqueous humor (Grade 3 or higher in clinical signs and grading) as measured with a slit lamp microscope
•5. Patients giving written informed consent prior to initiation of the study

•1. Pregnant or nursing females
•2. Patients receiving systemic administration or topical administration to the head or face including instillation of corticosteroid, nonsteroidal anti-inflammatory drugs, antiphlogistic enzymes, immunosuppressive drugs or colchicines within 1 week before the initial instillation of the study drug
•3. Patients with glaucoma or ocular hypertension (IOP ≥21 mmHg)
•4. Patients with corneal erosion or corneal ulcer
•5. Patients with viral keratoconjunctival diseases, tuberculos eye diseases, fungal eye diseases or bacterial eye diseases
•6. Patients with diabetes mellitus
•7. Patients with allergy to corticosteroids
•8. Patients participating in other clinical studies within 6 months before initiation of the present study
•9. Patients with sensitivity to steroids(Patients who previously exhibited increased IOP after instillation of a steroid ophthalmic solution)
•10. Patients with fibrins to such an extent that might affect measurement of flare

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