A phase I/II, double-blind, placebo-controlled study assessing the safety and efficacy of AVX-012 ophthalmic solution in subjects with mild-to-moderate dry eye syndrome - A phase I/II, double-blind, placebo-controlled study assessing the safety and efficacy of AVX-012

AVIZOREX PHARMA, S.L.0 个研究点目标入组 172 人2016年7月5日

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注册库

who.int

开始日期

2016年7月5日

结束日期

待定

最后更新

7年前

研究类型

Interventional clinical trial of medicinal product

发起方

AVIZOREX PHARMA, S.L.

•Patients will be included in the study if all of the following criteria are met:
•Male or female subjects of at least 18 years of age.
•Diagnosis of dry eye (by a health care professional) for at least 3 months prior to screening visit.
•Normal lid anatomy.
•Intraocular pressure less than 22 mmHg (inclusive) in each eye.
•Best\-corrected visual acuity measured by ETDRS in each eye of 20/200 (logMAR 1\.0\) or better.
•Schirmer I test score of \= 3 mm to \= 9 mm/ 5 min (with anesthesia).
•SANDE symptom score of 50 or more.
•Total ocular staining of minimum 1 in Oxford scale with fluorescein and/or green lissamine.
•Willing and able to provide written informed consent prior to any study related procedures and to comply with all study requirements.

•Exclusion criteria will be defined ensuring that both ophthalmic and systemic criteria disqualify inappropriate subjects from inclusion in the clinical study.
•Patients will be excluded for participating in this study if 1 or more of the following criteria are met:
•Ophthalmic criteria:
•1\.History of other than dry eye, ocular surface of moderate to severe Meibomian gland disease (grades \+\+\+ to \+\+\+\+ \[moderately to severely altered expressibility and secretion quality]: moderate symptoms with mild to moderate corneal staining, mainly peripheral; or marked symptoms with marked corneal staining, central in addition), chronic, or acute ophthalmic disease in either eye, including glaucoma, macular degeneration, clinically significant cataract (primary or secondary).
•2\.Best\-corrected visual acuity score of 55 letters read or lower in each eye as measured by ETDRS (letters read method).
•3\.Any hypersensitivity to the use of the study product formulations or an allergy to any ingredient(s) contained within product formulations or products required while participating in the study, such as sodium fluorescein.
•4\.Intraocular, strabismus, or palpebral surgery or surgery in the orbit or glaucoma laser surgery within the previous 6 months.
•5\.History of refractive surgery in either eye (e.g., radial keratotomy, PRK, LASIK, etc.).
•6\.Ocular trauma within the past 6 months.
•7\.Ocular surgery or laser treatment within the past 3 months.