A Clinical Trial to Study the Efficacy, Safety and Tolerability of Bepotastine Besilate Ophthalmic SolutionVs. Olopatadine Hydrochloride Ophthalmic Solution in Subjects Suffering from Allergic Conjunctivitis

Ajanta Pharma Ltd0 个研究点目标入组 240 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.Subject with sign and symptoms of allergic conjunctivitis like ocular itching, eye lid swelling, tearing, photophobia, watery discharge, diagnosis of allergic conjunctivitis will be confirmed by conjunctival smear examination.
•2.Freshly diagnosed subject or Subjects who are previously diagnosed and on treatment of allergic conjunctivitis will undergo for 3 days wash out period
•3.Subject willing to sign informed consent form (ICF) prior to any screening procedure. For Minor subject (age below 18yrs) LAR (Legally Acceptable Representative) should be taken with assent.

•1.Subjects who took systemic administration of corticosteroids or immunosuppressive agents, or used ophthalmic ointments of corticosteroids within 1 week before instillation of the investigational drugs.
•2.Use of disallowed medications during the period indicated prior to study enrollment or during the study.
•3.Subject with dry eyes should be excluded from the trial
•4.Subject with Schirmer 10 should be excluded from the study.
•5.Subject who are blind or subject with single eye.
•6.Subjects who have planned surgery during trial period.
•7.Subject with Vernal Keratoconjunctivitis should be excluded from the trial.
•8.Subjects having corneal epithelial detachment or corneal ulcer in the target eye.
•9.Subjects who are required to wear contact lens during the study period.
•10.Subjects who are pregnant or may be pregnant or lactating.
•11.Subjects who have participated in other clinical studies within 3 months.
•12.Any ocular condition that, in the opinion of the investigator, could affect the subjectâ??s safety or trial parameters.
•13.Known contraindications or sensitivities to the study medication or its components.
•14.Other patients who in the opinion of the investigator/sub investigator were inappropriate for the study participation.

发起方