Comparison of NAABAK® efficacy versus FLUCON® in the treatment of moderate manifestations of allergic conjunctivitis to birch pollen in subjects exposed to birch in ALYATEC’s environmental exposure chamber (EEC)

THEA0 个研究点目标入组 24 人开始时间: 2021年1月27日最近更新: 2021年4月5日

试验速览

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•Adults aged 18-65 years, with moderate manifestations of allergic conjunctivitis with or without allergic rhinitis.
•The history of moderate conjunctivitis in the last 2 years according to EAACI recommendations.
•Positive Prick tests (papule diameter greater than 6 mm compared to the negative control),
•IgE specific to Bet v1 greater than 0.70 kUI / l
•Individual conjunctival challenge test positive for birch pollen (Abelson score = 5).
•Are the trial subjects under 18? no
•Number of subjects for this age range:
•F.1.2 Adults (18-64 years) yes
•F.1.2.1 Number of subjects for this age range 24
•F.1.3 Elderly (>=65 years) no
•F.1.3.1 Number of subjects for this age range

•Personal or family history of glaucoma
•Eye Hypertension
•Eye surgery within 6 months of inclusion in the study
•Other forms of allergic conjunctivitis: Vernal and atopic keratoconjunctivitis, giant papillary conjunctivitis, perannual allergic conjunctivitis
•Non-specific conjunctival hyperreactivity
•Herpetic keratitis
•Viral diseases of the cornea and conjunctiva
•Tuberculous lesions and untreated bacterial infections of the eye;
•Fungal diseases of ocular structures
•Affection of the sclera or cornea
•Dry eye syndrome
•dysimmune diseases that may interfere with the study (dry syndrome in the context of inflammatory rheumatism)
•Allergic pathology (rhinitis, conjunctivitis) not controlled
•Uncontrolled asthma requiring a short-acting B2 mimetic more than twice a week or requiring that taken within the last 15 days.

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