Evaluación de la Efectividad del Tratamiento Oftálmico con Eye Drops #2® en Pacientes con Conjuntivitis Alérgica / Evaluation of the Effectiveness of Ophthalmic treatment with Eye Drops # 2® in Patients with Allergic Conjunctivitis

El presente artículo muestra los resultados de un estudio que evaluó la efectividad de un medicamento oftálmico homeopático (Eye Drops #2®) en pacientes con conjuntivitis alérgica. 33 personas con antecedentes de respuesta positiva a la aplicación vía tópica ocular de alergeno se evaluaron a través de un modelo aleatorizado, doble ciego y controlado con placebo. Los participantes recibieron un alergeno solubilizado en dos visitas distintas, a fin de evaluar factores como la hiperemia conjuntival, epiescleral y ciliar, así como la quemosis, la hinchazón del párpado, el lagrimeo y la picazón. Luego de esto se les asignaron aleatoriamente dos frascos enmascarados con la indicación de que el contenido de uno se aplicaría en el glóbulo ocular derecho y el otro en el izquierdo (uno contenía el medicamento y el otro placebo). En una tercera visita, posterior al tratamiento, se evaluaron la comodidad y la seguridad del tratamiento, además de que se aplicó una dosis final de alergeno. Los resultados finales mostraron una reducción estadísticamente significativa de los síntomas y los signos de la conjuntivitis alérgica inducida durante la visita 3, por lo que el producto parece ser cómodo y seguro de usar. (AU)

This article presents the results of a study that evaluated the effectiveness of a homeopathic ophthalmic medication (Eye Drops #2®) in patients with allergic conjunctivitis. 33 subjects with a history of positive response to topical ocular allergen challenge were evaluated in a randomised, double-masked, placebo-controlled study. The subjects received a solubilized allergen in two different visits, to evaluate factors such as conjunctival, episcleral, and ciliary hyperemia, chemosis, eyelid swelling, tearing, and itching. After this, the subjects were randomly assigned to two masked bottles labeled right and left, one containing the active drug and the other containing a placebo. On a third visit, after the treatment, comfort and safety were assessed, and a final dose of allergen was applied. The final results showed a statistically significant reduction in the signs and symptoms of allergic conjunctivitis induced during visit 3, so the product seems to be comfortable and safe to use. (AU)

Validation of the Global Allergy and Asthma European Network (GA2LEN) chamber for trials in allergy: Innovation of a mobile allergen exposure chamber.

BACKGROUND: Field clinical trials of pollen allergy are affected by the impossibility of predicting and determining individual allergen exposure because of many factors (eg, pollen season, atmospheric variations, pollutants, and lifestyles). Environmental exposure chambers, delivering a fixed amount of allergen in a controlled environmental setting, can overcome these limitations. Environmental exposure chambers are currently already used in phase 2, 3, and even 4 trials. Unfortunately, few chambers exist in the world, and this makes it difficult to perform large, multicenter clinical trials. The new Global Allergy and Asthma European Network (GA2LEN) mobile exposure chamber is a step forward because the mobility of the chamber makes it convenient for patients to participate in clinical testing. OBJECTIVE: This study was made to validate the reproducibility, sensitivity, and specificity of the results obtained in the new GA2LEN chamber. METHODS: Seventy-two adult patients (19-61 years old) with allergic rhinitis with or without asthma caused by grass pollen were included in different clinical validation tests. Total symptom scores and total nasal symptom scores were recorded at time zero (0) and every 10 minutes during exposures, along with nasal and respiratory parameters. RESULTS: Exposure tests confirmed the reproducibility between subsequent runs and the sensitivity (P < .00001 vs patients exposed to placebo) and specificity (very low score in nonallergic subjects) in the GA2LEN chamber. No adverse reactions were recorded during the tests. CONCLUSIONS: The mobility of the GA2LEN chamber provides a new, potentially effective, and safe way of generating reliable data in allergy multicenter clinical trials.

Clinical cure of bacterial conjunctivitis with azithromycin 1%: vehicle-controlled, double-masked clinical trial.

PURPOSE: To analyze the effect of azithromycin 1% ophthalmic solution in DuraSite (InSite Vision, Inc, Alameda, California, USA) on bacterial conjunctivitis. DESIGN: Prospective, randomized, vehicle-controlled, parallel-group, double-masked multicenter clinical study. METHODS: Eligible male or female participants with a clinical diagnosis of acute bacterial conjunctivitis were randomized to either 1% azithromycin in DuraSite or vehicle for five days. Infected eyes were dosed twice daily on days 1 and 2 and once daily on days 3 through 5. Conjunctival cultures were obtained at baseline, visit 2 (day 3 or 4), and visit 3 (day 6 or 7). The primary end point was clinical resolution of signs and symptoms (rating of zero on ocular discharge, bulbar and palpebral injection) at visit 3. Efficacy measures were clinical resolution and bacterial eradication as evaluated in the per-protocol population. Safety was assessed by adverse events, slit-lamp findings, and ophthalmoscopy. RESULTS: Two hundred and seventy-nine participants (n = 130, 1% azithromycin in DuraSite; n = 149, vehicle), age one to 96 years, were evaluated for efficacy. Clinical resolution with azithromycin ophthalmic solution was statistically significant compared with that of vehicle (P = .030) at visit 3. Bacterial eradication rates with azithromycin ophthalmic solution reached 88.5% at visit 3 (P < .001) and included some pathogens resistant to azithromycin in vitro. Overall, adverse event rates were similar in both treatment groups. CONCLUSIONS: Azithromycin 1% ophthalmic solution in DuraSite showed statistically significant differences in clinical resolution and bacterial eradication rates when compared with vehicle. Because it was well tolerated in this population, it may be a viable treatment option for children and adults with bacterial conjunctivitis.

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.

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 < 0.05). Efficacy scores for the combination of emedastine and loratadine were significantly better than those for loratadine alone at 2 of 3 time points for itching and all time points for hyperemia (P < 0.05). The combination was significantly better than emedastine alone at I of 3 time points for itching and 6 of 9 time points for hyperemia (P < 0.05). 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.