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Mark B. Abelson - One of the best experts on this subject based on the ideXlab platform.
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a randomized double blind placebo controlled comparison of Emedastine 0 05 ophthalmic solution with loratadine 10 mg and their combination in the human conjunctival allergen challenge model
Clinical Therapeutics, 2002Co-Authors: Mark B. Abelson, Allen P. KaplanAbstract:Abstract Background: When selecting treatment for allergic conjunctivitis, a primary concern is whether to choose local or systemic therapy. Objective: This study compared the efficacy of topical Emedastine 0.05% ophthalmic solution with that of oral loratadine 10 mg and their combination in the conjunctival allergen challenge model of allergic conjunctivitis. Methods: This was a single-center, randomized, double-masked, placebo-controlled, parallel-group study. At visit 1, eligible subjects underwent conjunctival allergen challenge to identify the dose required to elicit a positive allergic reaction. After 7 days, subjects returned for visit 2, at which the allergen dose was confirmed. At visit 3, which took place 2 weeks later, subjects were randomized to receive either Emedastine plus placebo capsules, loratadine plus placebo eyedrops, or both Emedastine and loratadine. One hour after receiving study drug, subjects were challenged with allergen in both eyes. Allergic signs and symptoms were graded using standardized 5-point scales. The primary efficacy variables were itching and conjunctival hyperemia. Secondary efficacy variables were ciliary and episcleral hyperemia, chemosis, lid swelling, and tearing. Itching was graded subjectively at 3, 5, and 10 minutes after challenge. All other variables were assessed at 5, 10, and 20 minutes after challenge. Results: Eighty subjects (mean age, 43.68 years) were randomized to receive study treatment. Forty subjects (20 men, 20 women) received Emedastine plus placebo capsules, 20 (7 men, 13 women) received loratadine plus placebo eyedrops, and 20 (12 men, 8 women) received both active treatments. In the between-group efficacy comparison at visit 3, the difference in itching and hyperemia scores between Emedastine and loratadine was statistically significant at all time points (all, P P P Conclusion: In this study, Emedastine was more efficacious than loratadine for reducing the itching and redness associated with allergic conjunctivitis in the human conjunctival allergen challenge model.
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A randomized, double-blind, placebo-controlled comparison of Emedastine 0.05% ophthalmic solution with loratadine 10 mg and their combination in the human conjunctival allergen challenge model
Clinical therapeutics, 2002Co-Authors: Mark B. Abelson, Allen P. KaplanAbstract:Abstract Background: When selecting treatment for allergic conjunctivitis, a primary concern is whether to choose local or systemic therapy. Objective: This study compared the efficacy of topical Emedastine 0.05% ophthalmic solution with that of oral loratadine 10 mg and their combination in the conjunctival allergen challenge model of allergic conjunctivitis. Methods: This was a single-center, randomized, double-masked, placebo-controlled, parallel-group study. At visit 1, eligible subjects underwent conjunctival allergen challenge to identify the dose required to elicit a positive allergic reaction. After 7 days, subjects returned for visit 2, at which the allergen dose was confirmed. At visit 3, which took place 2 weeks later, subjects were randomized to receive either Emedastine plus placebo capsules, loratadine plus placebo eyedrops, or both Emedastine and loratadine. One hour after receiving study drug, subjects were challenged with allergen in both eyes. Allergic signs and symptoms were graded using standardized 5-point scales. The primary efficacy variables were itching and conjunctival hyperemia. Secondary efficacy variables were ciliary and episcleral hyperemia, chemosis, lid swelling, and tearing. Itching was graded subjectively at 3, 5, and 10 minutes after challenge. All other variables were assessed at 5, 10, and 20 minutes after challenge. Results: Eighty subjects (mean age, 43.68 years) were randomized to receive study treatment. Forty subjects (20 men, 20 women) received Emedastine plus placebo capsules, 20 (7 men, 13 women) received loratadine plus placebo eyedrops, and 20 (12 men, 8 women) received both active treatments. In the between-group efficacy comparison at visit 3, the difference in itching and hyperemia scores between Emedastine and loratadine was statistically significant at all time points (all, P P P Conclusion: In this study, Emedastine was more efficacious than loratadine for reducing the itching and redness associated with allergic conjunctivitis in the human conjunctival allergen challenge model.
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An Efficacy and Tolerance Comparison of Emedastine Difumarate 0.05% and Levocabastine Hydrochloride 0.05%: Reducing Chemosis and Eyelid Swelling in Subjects with Seasonal Allergic Conjunctivitis
Acta Ophthalmologica Scandinavica, 2000Co-Authors: Marino Discepola, Jean Deschenes, Andrea Leonardi, Antonio G. Secchi, Mark B. AbelsonAbstract:. Purpose: To compare Emedastine ophthalmic solution 0.05% BID to levocabastine ophthalmic suspension 0.05% BID in reducing chemosis, eyelid swelling and other signs and symptoms in subjects with seasonal allergic conjunctivitis. Methods: In a randomized, double-masked, parallel controlled study, Emedastine ophthalmic solution 0.05% BID was compared to levocabastine ophthalmic suspension 0.05% BID for control of chemosis, eyelid swelling and other parameters in the environmental allergy study model. Results: At Days 7, 14, 30 and 42, Emedastine was significantly better than levocabastine at controlling chemosis and eyelid swelling (p
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an efficacy and tolerance comparison of Emedastine difumarate 0 05 and levocabastine hydrochloride 0 05 reducing chemosis and eyelid swelling in subjects with seasonal allergic conjunctivitis
Acta Ophthalmologica Scandinavica, 2000Co-Authors: Marino Discepola, Jean Deschenes, Andrea Leonardi, Antonio G. Secchi, Mark B. AbelsonAbstract:. Purpose: To compare Emedastine ophthalmic solution 0.05% BID to levocabastine ophthalmic suspension 0.05% BID in reducing chemosis, eyelid swelling and other signs and symptoms in subjects with seasonal allergic conjunctivitis. Methods: In a randomized, double-masked, parallel controlled study, Emedastine ophthalmic solution 0.05% BID was compared to levocabastine ophthalmic suspension 0.05% BID for control of chemosis, eyelid swelling and other parameters in the environmental allergy study model. Results: At Days 7, 14, 30 and 42, Emedastine was significantly better than levocabastine at controlling chemosis and eyelid swelling (p<0.05). A statistical trend was seen at Day 3 (0.05
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safety and efficacy comparison of Emedastine 0 05 ophthalmic solution compared to levocabastine 0 05 ophthalmic suspension in pediatric subjects with allergic conjunctivitis
Acta Ophthalmologica Scandinavica, 2000Co-Authors: Antonio G. Secchi, Jean Deschenes, Andrea Leonardi, G. Ciprandi, Mark B. AbelsonAbstract:. Purpose: To determine the efficacy and tolerance of Emedastine 0.05% ophthalmic solution compared to levocabastine 0.05% ophthalmic suspension in pediatric subjects. Methods and Materials: In a randomized, double-masked, parallel controlled study, Emedastine 0.05% ophthalmic solution BID was compared to levocabastine 0.05% ophthalmic suspension BID, for control of the signs and symptoms of allergic conjunctivitis in pediatric subjects ages 3–16. Subjects who met all inclusion and exclusion criteria received masked study medication with instructions to instill drops twice daily, in the morning and evening. A diary was completed by the parents four times daily for the first two and last two weeks of the study. Treatment lasted 42 days. Drug efficacy was assessed at the initial administration in the office at Day 0 and after 3, 7, 14, 30 and 42 days. Results: Overall results showed both drugs have an effect and that Emedastine was significantly superior (p<0.05) to levocabastine for the relief of chemosis on Days 14, 30 and 42; of itching on follow-up Days 30 and 42 (p<0.05); of redness on Days 30 and 42; for eyelid swelling on Days 14 and 30; and for physician's impression score on Days 7, 14, 30 and 42. Conclusion: These results confirm previous preclinical and clinical data on the potent and long acting efficacy of this promising new ophthalmic anti-allergic drug, Emedastine in pediatric subjects.
Kathleen L. Krenzer - One of the best experts on this subject based on the ideXlab platform.
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Emedastine ophthalmic solution 0 05 versus levocabastine ophthalmic suspension 0 05 in the treatment of allergic conjunctivitis using the conjunctival allergen challenge model
American Journal of Ophthalmology, 2000Co-Authors: Peter A. Netland, Charles Leahy, Kathleen L. KrenzerAbstract:Abstract PURPOSE: To compare a new ocular antihistamine, Emedastine difumarate (Emadine Ophthalmic Solution 0.05%; Alcon Laboratories, Fort Worth, Texas), with the marketed ocular antihistamine, levocabastine hydrochloride (Livostin Ophthalmic Suspension 0.05%; CIBA Vision, Atlanta, Georgia), in the treatment of allergic conjunctivitis after conjunctival allergen challenge. METHODS: We performed a prospective, double-masked, randomized, contralateral eye study comparing Emedastine 0.05% in one eye with levocabastine 0.05% or Emedastine vehicle (placebo) in the contralateral eye. Efficacy was determined 10 minutes and 2 hours after administration of study medications. Ocular itching and redness scores were recorded 3, 5, and 10 minutes after conjunctival allergen challenge. RESULTS: A total of 97 subjects with a history of allergic conjunctivitis and a positive response to a diagnostic test were evaluable for safety analysis, and 91 subjects were evaluable for the efficacy analysis. Emadastine 0.05% was statistically significantly more effective than levocabastine 0.05% in reducing ocular itching after conjunctival allergen challenge in both the 10-minute and the 2-hour challenge ( P CONCLUSIONS: After conjunctival allergen challenge, emadastine 0.05% is significantly more effective than levocabastine 0.05% in reducing ocular itching associated with allergic conjunctivitis. The two compounds are equivalent in controlling the conjunctival redness associated with allergic conjunctivitis.
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Emedastine ophthalmic solution 0.05% versus levocabastine ophthalmic suspension 0.05% in the treatment of allergic conjunctivitis using the conjunctival allergen challenge model.
American journal of ophthalmology, 2000Co-Authors: Peter A. Netland, Charles D. Leahy, Kathleen L. KrenzerAbstract:Abstract PURPOSE: To compare a new ocular antihistamine, Emedastine difumarate (Emadine Ophthalmic Solution 0.05%; Alcon Laboratories, Fort Worth, Texas), with the marketed ocular antihistamine, levocabastine hydrochloride (Livostin Ophthalmic Suspension 0.05%; CIBA Vision, Atlanta, Georgia), in the treatment of allergic conjunctivitis after conjunctival allergen challenge. METHODS: We performed a prospective, double-masked, randomized, contralateral eye study comparing Emedastine 0.05% in one eye with levocabastine 0.05% or Emedastine vehicle (placebo) in the contralateral eye. Efficacy was determined 10 minutes and 2 hours after administration of study medications. Ocular itching and redness scores were recorded 3, 5, and 10 minutes after conjunctival allergen challenge. RESULTS: A total of 97 subjects with a history of allergic conjunctivitis and a positive response to a diagnostic test were evaluable for safety analysis, and 91 subjects were evaluable for the efficacy analysis. Emadastine 0.05% was statistically significantly more effective than levocabastine 0.05% in reducing ocular itching after conjunctival allergen challenge in both the 10-minute and the 2-hour challenge ( P CONCLUSIONS: After conjunctival allergen challenge, emadastine 0.05% is significantly more effective than levocabastine 0.05% in reducing ocular itching associated with allergic conjunctivitis. The two compounds are equivalent in controlling the conjunctival redness associated with allergic conjunctivitis.
Laszlo Endre - One of the best experts on this subject based on the ideXlab platform.
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The prompt effect of Emedastine eye drop and the safety of its permanent use in children suffering from acute seasonal allergic conjunctivitis
Orvosi hetilap, 2007Co-Authors: Laszlo EndreAbstract:Bevezetes : Minden betegseg kezelese soran előnyos, ha az alkalmazott gyogyszer koncentracioja a celszervben a legmagasabb. Ebből kovetkezik, hogy a kotőhartya betegsegeit, ha lehet, szemcseppekkel kezeljuk. Celok: Szerző celja az Emedastine hatoanyagu szemcsepp hatekonysaganak felmerese szezonalis allergias kotőhartya-gyulladasban szenvedő gyermekeken. Modszer: 2 vizsgalat tortent. Az első vizsgalat soran 20 heveny szezonalis allergias kotőhartya-gyulladasban szenvedő gyermekbeteg kapott Emedastine difumarat (H 1 antihisztamin) tartalmu Emadine szemcseppet. Kotőhartyajuk verbőseget es viszkető erzeset 0-tol 4-ig terjedő skalan regisztraltak, ahol 4 jelentette a legsulyosabb tuneteket. A 2. vizsgalatban 232 masik gyermek kapta e szemcseppet 2 pollen szezonon keresztul es vizsgaltak az esetleges hatascsokkenest es mellekhatasokat. Eredmenyek: A kotőhartya viszkető erzete atlagosan 3, verbősege atlagosan 8 perc alatt csokkent szignifikans mertekben. A 2. vizsgalat soran a 232 gyermek kozul egy sem kenyszeru...
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Emedastine hatóanyagú szemcsepp hatékonysága és biztonságossága heveny szezonális allergiás kötőhártya-gyulladásban szenvedő gyermekeken = The prompt effect of Emedastine eye drop and the safety of its permanent use in children suffering from acute s
2007Co-Authors: Laszlo EndreAbstract:Bevezetes: Minden betegseg kezelese soran előnyos, ha az alkalmazott gyogyszer koncentracioja a celszervben a legmagasabb. Ebből kovetkezik, hogy a kotőhartya betegsegeit, ha lehet, szemcseppekkel kezeljuk. Celok: Szerző celja az Emedastine hatoanyagu szemcsepp hatekonysaganak felmerese szezonalis allergias kotőhartya-gyulladasban szenvedő gyermekeken. Modszer: 2 vizsgalat tortent. Az első vizsgalat soran 20 heveny szezonalis allergias kotőhartya-gyulladasban szenvedő gyermekbeteg kapott Emedastine difumarat (H1 antihisztamin) tartalmu Emadine szemcseppet. Kotőhartyajuk verbőseget es viszkető erzeset 0-tol 4-ig terjedő skalan regisztraltak, ahol 4 jelentette a legsulyosabb tuneteket. A 2. vizsgalatban 232 masik gyermek kapta e szemcseppet 2 pollen szezonon keresztul es vizsgaltak az esetleges hatascsokkenest es mellekhatasokat. Eredmenyek: A kotőhartya viszkető erzete atlagosan 3, verbősege atlagosan 8 perc alatt csokkent szignifikans mertekben. A 2. vizsgalat soran a 232 gyermek kozul egy sem kenyszerult a kezeles modositasara hatastalansag, vagy valamilyen kellemetlen mellekhatas miatt. Kovetkeztetesek: Az Emadine szemcsepp igen gyorsan es hatekonyan csokkenti a kotőhartya-viszketest es -verbőseget. Mar 3 eves kisgyermek is jol tűrte, es tartos hasznalat eseten sem csokkent a hatekonysaga. Introduction: In the treatment of any disease, it is advantageous if the concentration of the administered drug is highest in the target organ. It follows that, if possible, diseases of the conjunctiva should primarily be treated with eye drops. Aims: The author investigated the effect of an eye drop with selective H1-receptor antagonist properties, on children suffering from acute seasonal conjunctivitis. Method: During the first experiment 20 children (suffering from acute seasonal allergic conjunctivitis) had received Emadine eye drop (containing Emedastine difumarate, an H1 antihistamine agent). The severity of the itching of the eye and the grade of hyperemia of the conjunctiva were scored on scales ranging 0 to 4 (score 4 representing the most severe symptoms). In the second experiment 232 other children had received this eye drop during two pollen seasons and the author investigated its effectiveness and side effects. Results: The conjunctival itching decreased within less than 3 minutes significantly, and the redness was also reduced in an average of 8 minutes. In the second experiment none of the 232 children had to change this drug because of its ineffectiveness or side effects. Conclusions: Emadine eye drop decreases the itching and the redness of the conjunctiva very quickly and effectively. It is usable even for three years old patients, and it keeps its effectiveness during the long-term treatment, too.
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Emedastine hatoanyagu szemcsepp hatekonysaga es biztonsagossaga heveny szezonalis allergias kotőhartya gyulladasban szenvedő gyermekeken the prompt effect of Emedastine eye drop and the safety of its permanent use in children suffering from acute sea
2007Co-Authors: Laszlo EndreAbstract:Bevezetes: Minden betegseg kezelese soran előnyos, ha az alkalmazott gyogyszer koncentracioja a celszervben a legmagasabb. Ebből kovetkezik, hogy a kotőhartya betegsegeit, ha lehet, szemcseppekkel kezeljuk. Celok: Szerző celja az Emedastine hatoanyagu szemcsepp hatekonysaganak felmerese szezonalis allergias kotőhartya-gyulladasban szenvedő gyermekeken. Modszer: 2 vizsgalat tortent. Az első vizsgalat soran 20 heveny szezonalis allergias kotőhartya-gyulladasban szenvedő gyermekbeteg kapott Emedastine difumarat (H1 antihisztamin) tartalmu Emadine szemcseppet. Kotőhartyajuk verbőseget es viszkető erzeset 0-tol 4-ig terjedő skalan regisztraltak, ahol 4 jelentette a legsulyosabb tuneteket. A 2. vizsgalatban 232 masik gyermek kapta e szemcseppet 2 pollen szezonon keresztul es vizsgaltak az esetleges hatascsokkenest es mellekhatasokat. Eredmenyek: A kotőhartya viszkető erzete atlagosan 3, verbősege atlagosan 8 perc alatt csokkent szignifikans mertekben. A 2. vizsgalat soran a 232 gyermek kozul egy sem kenyszerult a kezeles modositasara hatastalansag, vagy valamilyen kellemetlen mellekhatas miatt. Kovetkeztetesek: Az Emadine szemcsepp igen gyorsan es hatekonyan csokkenti a kotőhartya-viszketest es -verbőseget. Mar 3 eves kisgyermek is jol tűrte, es tartos hasznalat eseten sem csokkent a hatekonysaga. Introduction: In the treatment of any disease, it is advantageous if the concentration of the administered drug is highest in the target organ. It follows that, if possible, diseases of the conjunctiva should primarily be treated with eye drops. Aims: The author investigated the effect of an eye drop with selective H1-receptor antagonist properties, on children suffering from acute seasonal conjunctivitis. Method: During the first experiment 20 children (suffering from acute seasonal allergic conjunctivitis) had received Emadine eye drop (containing Emedastine difumarate, an H1 antihistamine agent). The severity of the itching of the eye and the grade of hyperemia of the conjunctiva were scored on scales ranging 0 to 4 (score 4 representing the most severe symptoms). In the second experiment 232 other children had received this eye drop during two pollen seasons and the author investigated its effectiveness and side effects. Results: The conjunctival itching decreased within less than 3 minutes significantly, and the redness was also reduced in an average of 8 minutes. In the second experiment none of the 232 children had to change this drug because of its ineffectiveness or side effects. Conclusions: Emadine eye drop decreases the itching and the redness of the conjunctiva very quickly and effectively. It is usable even for three years old patients, and it keeps its effectiveness during the long-term treatment, too.
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effects of Emedastine eyedrops on acute seasonal allergic conjunctivitis in children
Orvosi Hetilap, 2003Co-Authors: Laszlo EndreAbstract:: The developments of the symptoms of acute allergic inflammation of the conjunctiva (itching of the eye, conjunctival hyperaemia and oedema, and lacrimation) is largely due to the histamine released in the course of the allergic reaction. A major role in its treatment is therefore played by eyedrops with an antihistamine effect. The aims of the present study were to establish whether there is a rapid effect of eyedrops containing the selective H1 receptor blocker Emedastine on acute seasonal allergic conjunctivitis and, if so, the time required for this effect to develop. Eyedrops containing Emedastine were administered in the ragweed season to 20 children (12 boys and 8 girls) with acute allergic inflammation of the conjunctiva resulting from a hypersensitivity to ragweed pollen, the average age of the 20 children was 12.3 years (range: 5-19). The degrees of itching of the eye and of conjunctival hyperaemia were each characterised on a scale ranging from 0 to 4 (4 denoting the most severe symptoms). It was found that, after a single administration of 1 Emedastine eyedrop, the degree of itching of the eye fell from the starting score of 2.85 +/- 0.75 to 0.45 +/- 0.51 within an average of 2.95 minutes, while the conjunctival hyperaemia fell from 2.35 +/- 0.59 to 0.55 +/- 0.51 in an average of 7.7 minutes. The level of the improvement for both symptoms was highly significant. An undesirable side effect (a burning sensation on the eyeball) was observed in one case. It may be stated that the eyedrop containing Emedastine effectively decreases the extents of itching of the eye and conjunctival hyperaemia in children with acute allergic conjunctivitis, its effects are exerted within minutes.
Endre Laszlo - One of the best experts on this subject based on the ideXlab platform.
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Emedastine hatóanyagú szemcsepp hatékonysága és biztonságossága heveny szezonális allergiás kötőhártya-gyulladásban szenvedő gyermekeken = The prompt effect of Emedastine eye drop and the safety of its permanent use in children suffering from acute s
'Akademiai Kiado Zrt.', 2027Co-Authors: Endre LaszloAbstract:Bevezetés: Minden betegség kezelése során előnyös, ha az alkalmazott gyógyszer koncentrációja a célszervben a legmagasabb. Ebből következik, hogy a kötőhártya betegségeit, ha lehet, szemcseppekkel kezeljük. Célok: Szerző célja az Emedastine hatóanyagú szemcsepp hatékonyságának felmérése szezonális allergiás kötőhártya-gyulladásban szenvedő gyermekeken. Módszer: 2 vizsgálat történt. Az első vizsgálat során 20 heveny szezonális allergiás kötőhártya-gyulladásban szenvedő gyermekbeteg kapott Emedastine difumarat (H1 antihisztamin) tartalmú Emadine szemcseppet. Kötőhártyájuk vérbőségét és viszkető érzését 0-tól 4-ig terjedő skálán regisztrálták, ahol 4 jelentette a legsúlyosabb tüneteket. A 2. vizsgálatban 232 másik gyermek kapta e szemcseppet 2 pollen szezonon keresztül és vizsgálták az esetleges hatáscsökkenést és mellékhatásokat. Eredmények: A kötőhártya viszkető érzete átlagosan 3, vérbősége átlagosan 8 perc alatt csökkent szignifikáns mértékben. A 2. vizsgálat során a 232 gyermek közül egy sem kényszerült a kezelés módosítására hatástalanság, vagy valamilyen kellemetlen mellékhatás miatt. Következtetések: Az Emadine szemcsepp igen gyorsan és hatékonyan csökkenti a kötőhártya-viszketést és -vérbőséget. Már 3 éves kisgyermek is jól tűrte, és tartós használat esetén sem csökkent a hatékonysága. Introduction: In the treatment of any disease, it is advantageous if the concentration of the administered drug is highest in the target organ. It follows that, if possible, diseases of the conjunctiva should primarily be treated with eye drops. Aims: The author investigated the effect of an eye drop with selective H1-receptor antagonist properties, on children suffering from acute seasonal conjunctivitis. Method: During the first experiment 20 children (suffering from acute seasonal allergic conjunctivitis) had received Emadine eye drop (containing Emedastine difumarate, an H1 antihistamine agent). The severity of the itching of the eye and the grade of hyperemia of the conjunctiva were scored on scales ranging 0 to 4 (score 4 representing the most severe symptoms). In the second experiment 232 other children had received this eye drop during two pollen seasons and the author investigated its effectiveness and side effects. Results: The conjunctival itching decreased within less than 3 minutes significantly, and the redness was also reduced in an average of 8 minutes. In the second experiment none of the 232 children had to change this drug because of its ineffectiveness or side effects. Conclusions: Emadine eye drop decreases the itching and the redness of the conjunctiva very quickly and effectively. It is usable even for three years old patients, and it keeps its effectiveness during the long-term treatment, too
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Emedastine hatoanyagu szemcsepp hatekonysaga es biztonsagossaga heveny szezonalis allergias kotohartya gyulladasban szenvedo gyermekeken
2007Co-Authors: Endre LaszloAbstract:Bevezetes: Minden betegseg kezelese soran elonyos, ha az alkalmazott gyogyszer koncentracioja a celszervben a legmagasabb. Ebbol kovetkezik, hogy a kotohartya betegsegeit, ha lehet, szemcseppekkel kezeljuk. Celok: Szerzo celja az Emedastine hatoanyagu szemcsepp hatekonysaganak felmerese szezonalis allergias kotohartya-gyulladasban szenvedo gyermekeken. Modszer: 2 vizsgalat tortent. Az elso vizsgalat soran 20 heveny szezonalis allergias kotohartya-gyulladasban szenvedo gyermekbeteg kapott Emedastine difumarat (H 1 antihisztamin) tartalmu Emadine szemcseppet. Kotohartyajuk verboseget es viszketo erzeset 0-tol 4-ig terjedo skalan regisztraltak, ahol 4 jelentette a legsulyosabb tuneteket. A 2. vizsgalatban 232 masik gyermek kapta e szemcseppet 2 pollen szezonon keresztul es vizsgaltak az esetleges hatascsokkenest es mellekhatasokat. Eredmenyek: A kotohartya viszketo erzete atlagosan 3, verbosege atlagosan 8 perc alatt csokkent szignifikans mertekben. A 2. vizsgalat soran a 232 gyermek kozul egy sem kenyszerult a kezeles modositasara hatastalansag, vagy valamilyen kellemetlen mellekhatas miatt. Kovetkeztetesek: Az Emadine szemcsepp igen gyorsan es hatekonyan csokkenti a kotohartya-viszketest es -verboseget. Mar 3 eves kisgyermek is jol turte, es tartos hasznalat eseten sem csokkent a hatekonysaga. Kulcsszavak: heveny szezonalis allergias kotohartya-gyulladas, Emedastine szemcsepp, helyi antihisztamin kezeles The prompt effect of Emedastine eye drop and the safety of its permanent use in children suffering from acute seasonal allergic conjunctivitis. Introduction: In the treatment of any disease, it is advantageous if the concentration of the administered drug is highest in the target organ. It follows that, if possible, diseases of the conjunctiva should primarily be treated with eye drops. Aims: The author investigated the effect of an eye drop with selective H 1-receptor antagonist properties, on children suffering from acute seasonal conjunctivitis. Method: During the first experiment 20 children (suffering from acute seasonal allergic conjunctivitis) had received Emadine eye drop (containing Emedastine difumarate, an H 1 antihistamine agent). The severity of the itching of the eye and the grade of hyperemia of the conjunctiva were scored on scales ranging 0 to 4 (score 4 representing the most severe symptoms). In the second experiment 232 other children had received this eye drop during two pollen seasons and the author investigated its effectiveness and side effects. Results: The conjunctival itching decreased within less than 3 minutes significantly, and the redness was also reduced in an average of 8 minutes. In the second experiment none of the 232 children had to change this drug because of its ineffectiveness or side effects. Conclusions: Emadine eye drop decreases the itching and the redness of the conjunctiva very quickly and effectively. It is usable even for three years old patients, and it keeps its effectiveness during the long-term treatment, too.
Andrea Leonardi - One of the best experts on this subject based on the ideXlab platform.
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randomized double masked placebo controlled comparison of the efficacy of Emedastine difumarate 0 05 ophthalmic solution and ketotifen fumarate 0 025 ophthalmic solution in the human conjunctival allergen challenge model
Clinical Therapeutics, 2002Co-Authors: Peter A Darienzo, Andrea Leonardi, George BenschAbstract:Abstract Background: Emedastine difumarate 0.05% ophthalmic solution and ketotifen fumarate 0.025% ophthalmic solution are 2 topical antiallergic agents available in the United States and other countries. Emedastine is indicated for the temporary relief of the signs and symptoms of allergic conjunctivitis. Ketotifen is indicated for the temporary relief of ocular itching caused by allergic conjunctivitis. Objective: The purpose of this study was to compare the efficacy of these agents in the temporary relief of ocular itching due to allergic conjunctivitis. The 2 agents were compared with each other and with placebo (artificial tears) using the conjunctival allergen challenge (CAC) model. Methods: This was a single-center, randomized, double-masked, placebo-controlled study. At visit 1, CAC was performed on eligible subjects to identify the dose required to elicit a positive allergic reaction. Subjects returned after 7 days for visit 2 to confirm the allergen dose. On day 14 (±3) of the study, enrolled subjects were randomized to 1 of 3 treatment groups: Emedastine in 1 eye and placebo in the other, ketotifen in 1 eye and placebo in the other, or Emedastine in 1 eye and ketotifen in the other. In 25 subjects, bilateral CAC was performed 5 minutes after study medication instillation. In a second group of 20 subjects, CAC was performed 15 minutes after medication instillation. Itching was graded according to a standardized 5-point scale (0 = none to 4=severe itching) at 3, 5, and 10 minutes postchallenge. Differences in efficacy scores between treatments and versus placebo were compared using 2-sample t tests of equal variance. Results: A total of 45 patients (mean age, 41.2 years) received treatment: 16 received Emedastine in 1 eye and ketotifen in the other; 14 received Emedastine in 1 eye and placebo in the other; and 15 received ketotifen in 1 eye and placebo in the other. Both Emedastine and ketotifen significantly inhibited itching ( P Conclusion: The results of this study suggest that Emedastine and ketotifen are not significantly different with respect to anti-itching efficacy in the CAC model of acute allergic conjunctivitis.
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Randomized, double-masked, placebo-controlled comparison of the efficacy of Emedastine difumarate 0.05% ophthalmic solution and ketotifen fumarate 0.025% ophthalmic solution in the human conjunctival allergen challenge model.
Clinical therapeutics, 2002Co-Authors: Peter A. D'arienzo, Andrea Leonardi, George BenschAbstract:Abstract Background: Emedastine difumarate 0.05% ophthalmic solution and ketotifen fumarate 0.025% ophthalmic solution are 2 topical antiallergic agents available in the United States and other countries. Emedastine is indicated for the temporary relief of the signs and symptoms of allergic conjunctivitis. Ketotifen is indicated for the temporary relief of ocular itching caused by allergic conjunctivitis. Objective: The purpose of this study was to compare the efficacy of these agents in the temporary relief of ocular itching due to allergic conjunctivitis. The 2 agents were compared with each other and with placebo (artificial tears) using the conjunctival allergen challenge (CAC) model. Methods: This was a single-center, randomized, double-masked, placebo-controlled study. At visit 1, CAC was performed on eligible subjects to identify the dose required to elicit a positive allergic reaction. Subjects returned after 7 days for visit 2 to confirm the allergen dose. On day 14 (±3) of the study, enrolled subjects were randomized to 1 of 3 treatment groups: Emedastine in 1 eye and placebo in the other, ketotifen in 1 eye and placebo in the other, or Emedastine in 1 eye and ketotifen in the other. In 25 subjects, bilateral CAC was performed 5 minutes after study medication instillation. In a second group of 20 subjects, CAC was performed 15 minutes after medication instillation. Itching was graded according to a standardized 5-point scale (0 = none to 4=severe itching) at 3, 5, and 10 minutes postchallenge. Differences in efficacy scores between treatments and versus placebo were compared using 2-sample t tests of equal variance. Results: A total of 45 patients (mean age, 41.2 years) received treatment: 16 received Emedastine in 1 eye and ketotifen in the other; 14 received Emedastine in 1 eye and placebo in the other; and 15 received ketotifen in 1 eye and placebo in the other. Both Emedastine and ketotifen significantly inhibited itching ( P Conclusion: The results of this study suggest that Emedastine and ketotifen are not significantly different with respect to anti-itching efficacy in the CAC model of acute allergic conjunctivitis.
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Histamine-induced cytokine production and ICAM-1 expression in human conjunctival fibroblasts.
Current eye research, 2002Co-Authors: Andrea Leonardi, Giuseppe Defranchis, Massimo De Paoli, Iva Fregona, Mario Plebani, Antonio G. SecchiAbstract:Purpose. Conjunctival fibroblasts stimulated with histamine (H) may be directly involved in the inflammatory and remodeling processes of chronic allergic conjunctival diseases. Methods. Proinflammatory cytokine and growth factor production, and the expression of intercellular adhesion molecule-1 (ICAM-1) were studied in conjunctival fibroblast cultures challenged with different concentrations of H (from 10 -9 M to 10 -4 M). Interleukin (IL)-1, IL-4, IL-6, IL-8, tumor necrosis factor-alfa (TNF-a), fibroblast growth factor (FGF), epidermal growth factor (EGF) and transforming growth factor-beta (TGFs-1) were measured in supernatants. ICAM-1 expression was evaluated by a fluorescence activated cell sorter (FACS). Inhibitory effects of the H-1 antagonists (antiH): Emedastine, levocabastine, and azelastine, and of the antiH-2, cimetidine, on H-stimulated fibroblasts were evaluated by measuring both cytokines in supernatants and the cellular expression of ICAM-1. Results. Histamine increased the production of I...
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An Efficacy and Tolerance Comparison of Emedastine Difumarate 0.05% and Levocabastine Hydrochloride 0.05%: Reducing Chemosis and Eyelid Swelling in Subjects with Seasonal Allergic Conjunctivitis
Acta Ophthalmologica Scandinavica, 2000Co-Authors: Marino Discepola, Jean Deschenes, Andrea Leonardi, Antonio G. Secchi, Mark B. AbelsonAbstract:. Purpose: To compare Emedastine ophthalmic solution 0.05% BID to levocabastine ophthalmic suspension 0.05% BID in reducing chemosis, eyelid swelling and other signs and symptoms in subjects with seasonal allergic conjunctivitis. Methods: In a randomized, double-masked, parallel controlled study, Emedastine ophthalmic solution 0.05% BID was compared to levocabastine ophthalmic suspension 0.05% BID for control of chemosis, eyelid swelling and other parameters in the environmental allergy study model. Results: At Days 7, 14, 30 and 42, Emedastine was significantly better than levocabastine at controlling chemosis and eyelid swelling (p
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an efficacy and tolerance comparison of Emedastine difumarate 0 05 and levocabastine hydrochloride 0 05 reducing chemosis and eyelid swelling in subjects with seasonal allergic conjunctivitis
Acta Ophthalmologica Scandinavica, 2000Co-Authors: Marino Discepola, Jean Deschenes, Andrea Leonardi, Antonio G. Secchi, Mark B. AbelsonAbstract:. Purpose: To compare Emedastine ophthalmic solution 0.05% BID to levocabastine ophthalmic suspension 0.05% BID in reducing chemosis, eyelid swelling and other signs and symptoms in subjects with seasonal allergic conjunctivitis. Methods: In a randomized, double-masked, parallel controlled study, Emedastine ophthalmic solution 0.05% BID was compared to levocabastine ophthalmic suspension 0.05% BID for control of chemosis, eyelid swelling and other parameters in the environmental allergy study model. Results: At Days 7, 14, 30 and 42, Emedastine was significantly better than levocabastine at controlling chemosis and eyelid swelling (p<0.05). A statistical trend was seen at Day 3 (0.05