Biomaterial Database

Azelastine eye-drops in seasonal allergic conjunctivitis or rhinoconjunctivitis. A double-blind, randomized, placebo-controlled study. 1998

C Giede-Tuch, and M Westhoff, and A Zarth

This study was carried out to assess the efficacy of 0.025% and 0.05% azelastine eye-drops in patients with seasonal allergic conjunctivitis of > or = 1 year's duration. A total of 151 patients received 0.025% or 0.05% azelastine eye-drops or placebo b.i.d. for 14 days according to a double-blind, randomized, placebo-controlled, parallel-dosing design; 129 patients completed the study as planned. The three target symptoms, scored on 4-point scales, were itching, lacrimation, and redness of the eyes; responders were patients whose symptom sum score decreased by > or = 3 from a baseline score of > or = 6 by day 3. Mean scores of these and five other symptoms were recorded also on days 7 and 14, and patients kept daily diaries of the three main symptoms and swollen eyelids. Responder rates were 73% for 0.025% (P=0.115 vs placebo) and 82% for 0.05% azelastine eye-drops (P=0.011 vs placebo) and 56% for placebo. The time courses of the mean (investigators' and patients') scores for the three main symptoms reflected the dose-dependent effect of azelastine eye-drops. One patient each from the two azelastine groups and three from the placebo group withdrew because of inefficacy. Adverse drug reactions were reported by 14 and 24 patients receiving 0.025% and 0.05% azelastine eye-drops, respectively, and by eight placebo patients. These reactions were mainly slight application site reactions and taste perversion (bitter or unpleasant taste). Azelastine eye-drops are effective and well tolerated at a dose of 0.05% for the treatment of seasonal allergic conjunctivitis.

UI	MeSH Term	Description	Entries
D008297	Male		Males
D008875	Middle Aged	An adult aged 45 - 64 years.	Middle Age
D009883	Ophthalmic Solutions	Sterile solutions that are intended for instillation into the eye. It does not include solutions for cleaning eyeglasses or CONTACT LENS SOLUTIONS.	Eye Drop,Eyedrop,Eyedrops,Ophthalmic Solution,Eye Drops,Drop, Eye,Drops, Eye,Solution, Ophthalmic,Solutions, Ophthalmic
D010793	Phthalazines	Bicyclic heterocyclic compounds containing a BENZENE ring fused to PYRIDAZINE.
D003233	Conjunctivitis, Allergic	Conjunctivitis due to hypersensitivity to various allergens.	Allergic Conjunctivitis,Conjunctivitis, Atopic,Conjunctivitis, Giant Papillary,Conjunctivitis, Vernal,Keratoconjunctivitis, Vernal,Allergic Conjunctivitides,Atopic Conjunctivitides,Atopic Conjunctivitis,Conjunctivitides, Allergic,Conjunctivitides, Atopic,Conjunctivitides, Giant Papillary,Conjunctivitides, Vernal,Giant Papillary Conjunctivitides,Giant Papillary Conjunctivitis,Keratoconjunctivitides, Vernal,Papillary Conjunctivitides, Giant,Papillary Conjunctivitis, Giant,Vernal Conjunctivitides,Vernal Conjunctivitis,Vernal Keratoconjunctivitides,Vernal Keratoconjunctivitis
D004311	Double-Blind Method	A method of studying a drug or procedure in which both the subjects and investigators are kept unaware of who is actually getting which specific treatment.	Double-Masked Study,Double-Blind Study,Double-Masked Method,Double Blind Method,Double Blind Study,Double Masked Method,Double Masked Study,Double-Blind Methods,Double-Blind Studies,Double-Masked Methods,Double-Masked Studies,Method, Double-Blind,Method, Double-Masked,Methods, Double-Blind,Methods, Double-Masked,Studies, Double-Blind,Studies, Double-Masked,Study, Double-Blind,Study, Double-Masked
D005260	Female		Females
D006255	Rhinitis, Allergic, Seasonal	Allergic rhinitis that occurs at the same time every year. It is characterized by acute CONJUNCTIVITIS with lacrimation and ITCHING, and regarded as an allergic condition triggered by specific ALLERGENS.	Hay Fever,Pollen Allergy,Pollinosis,Seasonal Allergic Rhinitis,Hayfever,Allergic Rhinitides, Seasonal,Allergic Rhinitis, Seasonal,Allergies, Pollen,Allergy, Pollen,Fever, Hay,Pollen Allergies,Pollinoses,Rhinitides, Seasonal Allergic,Rhinitis, Seasonal Allergic,Seasonal Allergic Rhinitides
D006634	Histamine H1 Antagonists	Drugs that selectively bind to but do not activate histamine H1 receptors, thereby blocking the actions of endogenous histamine. Included here are the classical antihistaminics that antagonize or prevent the action of histamine mainly in immediate hypersensitivity. They act in the bronchi, capillaries, and some other smooth muscles, and are used to prevent or allay motion sickness, seasonal rhinitis, and allergic dermatitis and to induce somnolence. The effects of blocking central nervous system H1 receptors are not as well understood.	Antihistamines, Classical,Antihistaminics, Classical,Antihistaminics, H1,Histamine H1 Antagonist,Histamine H1 Receptor Antagonist,Histamine H1 Receptor Antagonists,Histamine H1 Receptor Blockaders,Antagonists, Histamine H1,Antagonists, Histamine H1 Receptor,Antihistamines, Sedating,Blockaders, Histamine H1 Receptor,First Generation H1 Antagonists,H1 Receptor Blockaders,Histamine H1 Blockers,Receptor Blockaders, H1,Antagonist, Histamine H1,Classical Antihistamines,Classical Antihistaminics,H1 Antagonist, Histamine,H1 Antagonists, Histamine,H1 Antihistaminics,Sedating Antihistamines
D006801	Humans	Members of the species Homo sapiens.	Homo sapiens,Man (Taxonomy),Human,Man, Modern,Modern Man