{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,3,18]],"date-time":"2026-03-18T20:58:51Z","timestamp":1773867531791,"version":"3.50.1"},"reference-count":27,"publisher":"Wiley","issue":"9","license":[{"start":{"date-parts":[[2022,4,5]],"date-time":"2022-04-05T00:00:00Z","timestamp":1649116800000},"content-version":"vor","delay-in-days":0,"URL":"http:\/\/creativecommons.org\/licenses\/by-nc\/4.0\/"}],"content-domain":{"domain":["onlinelibrary.wiley.com"],"crossmark-restriction":true},"short-container-title":["Clin Experimental Allergy"],"published-print":{"date-parts":[[2022,9]]},"abstract":"<jats:title>Abstract<\/jats:title><jats:sec><jats:title>Background<\/jats:title><jats:p>Topical mast cell stabilizers were previously shown to treat the signs and symptoms of seasonal and perennial allergic conjunctivitis safely and effectively in active and placebo\u2010controlled trials. However, mast cell stabilizers have not been compared to topical corticosteroids for efficacy. We tested the non\u2010inferiority of a topical mast cell stabilizer, N\u2010acetyl aspartyl glutamic acid (4.9%, NAAGA), compared to fluorometholone (0.1%, FM) during controlled exposures to the airborne birch pollen allergen, Bet v 1, in an environmental exposure chamber (EEC).<\/jats:p><\/jats:sec><jats:sec><jats:title>Methods<\/jats:title><jats:p>This randomized, cross\u2010over, investigator\u2010blinded study included 24 patients with a history of birch pollen allergic conjunctivitis. Patients were randomized to 5\u00a0days of treatment with NAAGA, then FM (<jats:italic>n<\/jats:italic>\u00a0=\u00a012) or FM, then NAAGA (<jats:italic>n<\/jats:italic>\u00a0=\u00a012). After each treatment, patients were exposed to a fixed airborne concentration of Bet v 1 in ALYATEC EEC. The primary endpoint was the amount of allergen required to trigger a conjunctival response (Abelson score \u22655). Groups were compared with a linear model for cross\u2010over studies. Non\u2010inferiority was assumed, when the lower bound of the risk ratio confidence interval (CI) was &gt;0.5.<\/jats:p><\/jats:sec><jats:sec><jats:title>Results<\/jats:title><jats:p>At screening, the mean time\u2010to\u2010conjunctival response was 72.5\u00a0\u00b1\u00a035.9\u00a0min. NAAGA and FM extended the response time to 114.8\u00a0\u00b1\u00a055.0 and 116.6\u00a0\u00b1\u00a051.5\u00a0min respectively. The mean amounts of allergen required to trigger a conjunctival response were 1.165\u00a0ng after NAAGA and 1.193\u00a0ng after FM treatment. The risk ratio for the conjunctival response was 0.977 (95% CI: 0.812; 1.174), which indicated non\u2010inferiority. Adverse events occurred less frequently with NAAGA (29.2%) than with FM (58.3%).<\/jats:p><\/jats:sec><jats:sec><jats:title>Conclusion<\/jats:title><jats:p>In patients with allergic conjunctivitis to birch pollen, NAAGA was non\u2010inferior to FM in exposures to airborne Bet v 1. The EEC was a good model for simulating real\u2010life airborne allergen exposure and for demonstrating the efficacy and safety of eye drops for treating allergic conjunctivitis.<\/jats:p><\/jats:sec><jats:sec><jats:title>Trial registration<\/jats:title><jats:p>Not registered.<\/jats:p><\/jats:sec>","DOI":"10.1111\/cea.14130","type":"journal-article","created":{"date-parts":[[2022,3,18]],"date-time":"2022-03-18T09:06:38Z","timestamp":1647594398000},"page":"1091-1100","update-policy":"https:\/\/doi.org\/10.1002\/crossmark_policy","source":"Crossref","is-referenced-by-count":7,"title":["Efficacy of N\u2010acetyl aspartyl glutamic acid versus fluorometholone for treating allergic conjunctivitis in an environmental exposure chamber"],"prefix":"10.1111","volume":"52","author":[{"ORCID":"https:\/\/orcid.org\/0000-0001-5678-2214","authenticated-orcid":false,"given":"Fr\u00e9d\u00e9ric","family":"de Blay","sequence":"first","affiliation":[{"name":"ALYATEC Nouvel H\u00f4pital Civil 1 place de l\u2019H\u00f4pital  Strasbourg France"},{"name":"Department of Chest Diseases Strasbourg University Hospital FMTS EA 3070 Strasbourg University  Strasbourg France"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Alina","family":"Gherasim","sequence":"additional","affiliation":[{"name":"ALYATEC Nouvel H\u00f4pital Civil 1 place de l\u2019H\u00f4pital  Strasbourg France"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Nathalie","family":"Domis","sequence":"additional","affiliation":[{"name":"ALYATEC Nouvel H\u00f4pital Civil 1 place de l\u2019H\u00f4pital  Strasbourg France"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Ibrahim","family":"Choual","sequence":"additional","affiliation":[{"name":"ALYATEC Nouvel H\u00f4pital Civil 1 place de l\u2019H\u00f4pital  Strasbourg France"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Tristan","family":"Bourcier","sequence":"additional","affiliation":[{"name":"Department of Ophthalmology Strasbourg University Hospital FMTS Strasbourg University  Strasbourg France"}],"role":[{"role":"author","vocabulary":"crossref"}]}],"member":"311","published-online":{"date-parts":[[2022,4,5]]},"reference":[{"key":"e_1_2_9_2_1","doi-asserted-by":"publisher","DOI":"10.1111\/all.12009"},{"key":"e_1_2_9_3_1","doi-asserted-by":"publisher","DOI":"10.3111\/13696998.2011.576039"},{"key":"e_1_2_9_4_1","doi-asserted-by":"publisher","DOI":"10.1111\/cea.12536"},{"key":"e_1_2_9_5_1","doi-asserted-by":"publisher","DOI":"10.1016\/0034-6667(90)90114-X"},{"key":"e_1_2_9_6_1","doi-asserted-by":"publisher","DOI":"10.1111\/j.1398-9995.2007.01393.x"},{"key":"e_1_2_9_7_1","doi-asserted-by":"publisher","DOI":"10.1517\/14656566.2015.1040760"},{"key":"e_1_2_9_8_1","unstructured":"Committee for Medicinal Products for Human Use European Medicines Agency.Guideline on the clinical development of medicinal products for the treatment of allergic rhinoconjunctivitis. 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