â??A Phase III, Multicenter, Comparative, Randomized, Double blind, Two arm, Parallel group Clinical Study to evaluate Efficacy and Safety of Olopatadine Hydrochloride Ophthalmic Solution 0.7% w/v as compared with Olopatadine Hydrochloride Ophthalmic Solution 0.2% w/v for the treatment of Ocular Itching associated with Allergic Conjunctivitis.â??

Ajanta Pharma Ltd0 个研究点目标入组 219 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.Male or female subjects, aged 10 years to 65 years (both inclusive).
•2.Treatment naÃ¯ve subjects with diagnosis of ocular itching associated with allergic conjunctivitis in one or both the eyes.
•3.Subjects willing to discontinue contact lens wear for at least 72 hours prior to screening visit and throughout the study.
•4.Subjects who are willing to sign informed consent for participation in the study and willing to adhere to all protocol procedures

•1.Subjects with any contraindications or hypersensitivities to the use of the study medication or their components.
•2.Subjects who are blind or subjects with single eye will be excluded from the study.
•3.Subjects with Visual acuity of 20/80 in any eye.
•4.Subjects with known case of persistent dry eye syndrome or currently on treatment for dry eyes.
•5.Subjects with Vernal Keratoconjunctivitis (VKC), Atopic Keratoconjunctivitis (AKC) and Giant Papillary Conjunctivitis (GPC) will be excluded from the study.
•6.Subjects with presence of ocular infection (bacterial, viral or fungal) or history of ocular herpes within 30 days of screening visit.
•7.Subjects with presence of active blepharitis, active meibomian gland dysfunction, active rosacea affecting the ocular adnexa, follicular conjunctivitis, iritis, preauricular lymphadenopathy, ocular irritation not due to ocular allergy, or any other clinically significant ophthalmic abnormality that may affect the study outcomes.
•8.Subjects with chronic ocular degenerative condition or active intraocular inflammation that could worsen during the study.
•9.Subjects with known case of glaucoma will be excluded from the study.
•10.Subjects with known case of ocular surgery within 6 months or scheduled to undergo ocular surgery during the study period.

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