drugset / Trial / NCT03186755
Clinical Evaluation of Hylo-Dual Versus Patanol in Children With Seasonal Allergic Conjunctivitis
RandomizedParallel-groupDouble-blindTreatment
Summary
This study compares the efficacy of Hylo-Dual (Hyaluronic acid 0.05% \& Ectoine 2.0%) and Olopatadine (Olopatadine hydrochloride ophthalmic solution 0.1%) in the control of seasonal allergic conjunctivitis in the pediatric population. Half of participants will receive Hylo-Dual, while the other half will receive Olopatadine treatment for 2 months.
Timeline
- Start
- 2017-06-11
- Primary completion
- 2024-12
- Completion
- 2024-12
Publications
- Background Leonardi A. Emerging drugs for ocular allergy. Expert Opin Emerg Drugs. 2005 Aug;10(3):505-20. doi: 10.1517/14728214.10.3.505.
- Background Leonardi A. Pathophysiology of allergic conjunctivitis. Acta Ophthalmol Scand Suppl. 1999;(228):21-3. doi: 10.1111/j.1600-0420.1999.tb01167.x. No abstract available.
- Background Mortemousque B, Bourcier T, Khairallah M, Messaoud R, Brignole-Baudouin F, Renault D, Rebika H, Bremond-Gignac D; Ketotifen Study Group. Comparison of preservative-free ketotifen fumarate and preserved olopatadine hydrochloride eye drops in the treatment of moderate to severe seasonal allergic conjunctivitis. J Fr Ophtalmol. 2014 Jan;37(1):1-8. doi: 10.1016/j.jfo.2013.02.007. Epub 2013 Dec 31.
- Background Ciprandi G, Turner D, Gross RD. Double-masked, randomized, parallel-group study comparing olopatadine 0.1% ophthalmic solution with cromolyn sodium 2% and levocabastine 0.05% ophthalmic preparations in children with seasonal allergic conjunctivitis. Curr Ther Res Clin Exp. 2004 Mar;65(2):186-99. doi: 10.1016/S0011-393X(04)90032-X.
- Background Bielory L. Update on ocular allergy treatment. Expert Opin Pharmacother. 2002 May;3(5):541-53. doi: 10.1517/14656566.3.5.541.
- Background Bielory L, Lien KW, Bigelsen S. Efficacy and tolerability of newer antihistamines in the treatment of allergic conjunctivitis. Drugs. 2005;65(2):215-28. doi: 10.2165/00003495-200565020-00004.
- Background Katelaris CH, Ciprandi G, Missotten L, Turner FD, Bertin D, Berdeaux G; International Olopatadine Study Group. A comparison of the efficacy and tolerability of olopatadine hydrochloride 0.1% ophthalmic solution and cromolyn sodium 2% ophthalmic solution in seasonal allergic conjunctivitis. Clin Ther. 2002 Oct;24(10):1561-75. doi: 10.1016/s0149-2918(02)80060-1.
- Background McLaurin E, Narvekar A, Gomes P, Adewale A, Torkildsen G. Phase 3 Randomized Double-Masked Study of Efficacy and Safety of Once-Daily 0.77% Olopatadine Hydrochloride Ophthalmic Solution in Subjects With Allergic Conjunctivitis Using the Conjunctival Allergen Challenge Model. Cornea. 2015 Oct;34(10):1245-51. doi: 10.1097/ICO.0000000000000562.
- Background Torkildsen G, Narvekar A, Bergmann M. Efficacy and safety of olopatadine hydrochloride 0.77% in patients with allergic conjunctivitis using a conjunctival allergen-challenge model. Clin Ophthalmol. 2015 Sep 14;9:1703-13. doi: 10.2147/OPTH.S83263. eCollection 2015.
- Background Kam KW, Chen LJ, Wat N, Young AL. Topical Olopatadine in the Treatment of Allergic Conjunctivitis: A Systematic Review and Meta-analysis. Ocul Immunol Inflamm. 2017 Oct;25(5):663-677. doi: 10.3109/09273948.2016.1158282. Epub 2016 May 18.
- Background Bestvater T, Louis P, Galinski EA. Heterologous ectoine production in Escherichia coli: by-passing the metabolic bottle-neck. Saline Syst. 2008 Aug 29;4:12. doi: 10.1186/1746-1448-4-12.
- Background Banciu HL, Sorokin DY, Tourova TP, Galinski EA, Muntyan MS, Kuenen JG, Muyzer G. Influence of salts and pH on growth and activity of a novel facultatively alkaliphilic, extremely salt-tolerant, obligately chemolithoautotrophic sufur-oxidizing Gammaproteobacterium Thioalkalibacter halophilus gen. nov., sp. nov. from South-Western Siberian soda lakes. Extremophiles. 2008 May;12(3):391-404. doi: 10.1007/s00792-008-0142-1. Epub 2008 Feb 29.
- Background Beblo-Vranesevic K, Galinski EA, Rachel R, Huber H, Rettberg P. Influence of osmotic stress on desiccation and irradiation tolerance of (hyper)-thermophilic microorganisms. Arch Microbiol. 2017 Jan;199(1):17-28. doi: 10.1007/s00203-016-1269-6. Epub 2016 Jul 21.
- Background Harishchandra RK, Wulff S, Lentzen G, Neuhaus T, Galla HJ. The effect of compatible solute ectoines on the structural organization of lipid monolayer and bilayer membranes. Biophys Chem. 2010 Aug;150(1-3):37-46. doi: 10.1016/j.bpc.2010.02.007. Epub 2010 Feb 11.
- Background Dwivedi M, Brinkkotter M, Harishchandra RK, Galla HJ. Biophysical investigations of the structure and function of the tear fluid lipid layers and the effect of ectoine. Part B: artificial lipid films. Biochim Biophys Acta. 2014 Oct;1838(10):2716-27. doi: 10.1016/j.bbamem.2014.05.007. Epub 2014 May 20.
- Background Dwivedi M, Backers H, Harishchandra RK, Galla HJ. Biophysical investigations of the structure and function of the tear fluid lipid layer and the effect of ectoine. Part A: natural meibomian lipid films. Biochim Biophys Acta. 2014 Oct;1838(10):2708-15. doi: 10.1016/j.bbamem.2014.05.011. Epub 2014 May 17.
- Background Buenger J, Driller H. Ectoin: an effective natural substance to prevent UVA-induced premature photoaging. Skin Pharmacol Physiol. 2004 Sep-Oct;17(5):232-7. doi: 10.1159/000080216.
- Background DeLuise VP, Peterson WS. The use of topical Healon tears in the management of refractory dry-eye syndrome. Ann Ophthalmol. 1984 Sep;16(9):823-4.
- Background Stuart JC, Linn JG. Dilute sodium hyaluronate (Healon) in the treatment of ocular surface disorders. Ann Ophthalmol. 1985 Mar;17(3):190-2.
- Background Shimmura S, Ono M, Shinozaki K, Toda I, Takamura E, Mashima Y, Tsubota K. Sodium hyaluronate eyedrops in the treatment of dry eyes. Br J Ophthalmol. 1995 Nov;79(11):1007-11. doi: 10.1136/bjo.79.11.1007.
- Background Gill GW, Frost JK, Miller KA. A new formula for a half-oxidized hematoxylin solution that neither overstains nor requires differentiation. Acta Cytol. 1974 Jul-Aug;18(4):300-11. No abstract available.
- Background Papa V, Aragona P, Russo S, Di Bella A, Russo P, Milazzo G. Comparison of hypotonic and isotonic solutions containing sodium hyaluronate on the symptomatic treatment of dry eye patients. Ophthalmologica. 2001 Mar-Apr;215(2):124-7. doi: 10.1159/000050842.
- Background Wysenbeek YS, Loya N, Ben Sira I, Ophir I, Ben Shaul Y. The effect of sodium hyaluronate on the corneal epithelium. An ultrastructural study. Invest Ophthalmol Vis Sci. 1988 Feb;29(2):194-9.
- Background Condon PI, McEwen CG, Wright M, Mackintosh G, Prescott RJ, McDonald C. Double blind, randomised, placebo controlled, crossover, multicentre study to determine the efficacy of a 0.1% (w/v) sodium hyaluronate solution (Fermavisc) in the treatment of dry eye syndrome. Br J Ophthalmol. 1999 Oct;83(10):1121-4. doi: 10.1136/bjo.83.10.1121.
- Background Verin P, Easty DL, Secchi A, Ciprandi G, Partouche P, Nemeth-Wasmer G, Brancato R, Harrisberg CJ, Estivin-Ebrardt C, Coster DJ, Apel AJ, Coroneo MT, Knorr M, Carmichael TR, Kent-Smith BT, Abrantes P, Leonardi A, Cerqueti PM, Modorati G, Martinez M. Clinical evaluation of twice-daily emedastine 0.05% eye drops (Emadine eye drops) versus levocabastine 0.05% eye drops in patients with allergic conjunctivitis. Am J Ophthalmol. 2001 Jun;131(6):691-8. doi: 10.1016/s0002-9394(00)00947-8.
- Background Onguchi T, Dogru M, Okada N, Kato NA, Tanaka M, Takano Y, Fukagawa K, Shimazaki J, Tsubota K, Fujishima H. The impact of the onset time of atopic keratoconjunctivitis on the tear function and ocular surface findings. Am J Ophthalmol. 2006 Mar;141(3):569-71. doi: 10.1016/j.ajo.2005.09.032.
- Background Dogru M, Gunay M, Celik G, Aktas A. Evaluation of the tear film instability in children with allergic diseases. Cutan Ocul Toxicol. 2016 Mar;35(1):49-52. doi: 10.3109/15569527.2015.1010727. Epub 2015 Feb 19.
- Background Nebbioso M, Zicari AM, Celani C, Lollobrigida V, Grenga R, Duse M. Pathogenesis of Vernal Keratoconjunctivitis and Associated Factors. Semin Ophthalmol. 2015;30(5-6):340-4. doi: 10.3109/08820538.2013.874483. Epub 2014 Feb 27.
- Background Gelardi M, Leo ME, Quaranta VN, Iannuzzi L, Tripodi S, Quaranta N, Canonica GW, Passalacqua G. Clinical characteristics associated with conjunctival inflammation in allergic rhinoconjunctivitis. J Allergy Clin Immunol Pract. 2015 May-Jun;3(3):387-91.e1. doi: 10.1016/j.jaip.2015.01.006. Epub 2015 Jan 26.
- Background Bremond-Gignac D, Nischal KK, Mortemousque B, Gajdosova E, Granet DB, Chiambaretta F. Atopic Keratoconjunctivitis in Children: Clinical Features and Diagnosis. Ophthalmology. 2016 Feb;123(2):435-437. doi: 10.1016/j.ophtha.2015.07.012. Epub 2015 Aug 13. No abstract available.
- Background Villani E, Dello Strologo M, Pichi F, Luccarelli SV, De Cilla S, Serafino M, Nucci P. Dry Eye in Vernal Keratoconjunctivitis: A Cross-Sectional Comparative Study. Medicine (Baltimore). 2015 Oct;94(42):e1648. doi: 10.1097/MD.0000000000001648.
- Background Akil H, Celik F, Ulas F, Kara IS. Dry Eye Syndrome and Allergic Conjunctivitis in the Pediatric Population. Middle East Afr J Ophthalmol. 2015 Oct-Dec;22(4):467-71. doi: 10.4103/0974-9233.167814.
- Background Chen L, Pi L, Fang J, Chen X, Ke N, Liu Q. High incidence of dry eye in young children with allergic conjunctivitis in Southwest China. Acta Ophthalmol. 2016 Dec;94(8):e727-e730. doi: 10.1111/aos.13093. Epub 2016 May 26.
- Background Sanchez-Hernandez MC, Montero J, Rondon C, Benitez del Castillo JM, Velazquez E, Herreras JM, Fernandez-Parra B, Merayo-Lloves J, Del Cuvillo A, Vega F, Valero A, Panizo C, Montoro J, Matheu V, Lluch-Bernal M, Gonzalez ML, Gonzalez R, Dordal MT, Davila I, Colas C, Campo P, Anton E, Navarro A; SEAIC 2010 Rhinoconjunctivitis Committee; Spanish Group Ocular Surface-GESOC. Consensus document on allergic conjunctivitis (DECA). J Investig Allergol Clin Immunol. 2015;25(2):94-106.
- Background Vermeulen J, Mercer M. Comparison of the efficacy and tolerability of topical levocabastine and sodium cromoglycate in the treatment of seasonal allergic rhinoconjunctivitis in children. Pediatr Allergy Immunol. 1994 Nov;5(4):209-13. doi: 10.1111/j.1399-3038.1994.tb00241.x.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Ectoine | Unknown | 2 % | Other |
| Subject | Hyaluronic Acid | Other / unclassified | 0.05 % | Other |
| Comparator | Olopatadine | Other / unclassified | 0.1 % | Other |