The Comparison of 50% AS Versus PFAT+ 0.05 % COE in Severe Dry Eye Syndrome

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ClinicalTrials.gov Identifier: NCT03666884

Recruitment Status : Completed

First Posted : September 12, 2018

Last Update Posted : September 12, 2018

Sponsor:

Collaborator:

Usak State Hospital

Information provided by (Responsible Party):

Seref istek, Usak State Hospital

No Study Results Posted on ClinicalTrials.gov for this Study

About Study Results Reporting on ClinicalTrials.gov

Recruitment Status :	Completed
Actual Primary Completion Date :	March 15, 2016
Actual Study Completion Date :	October 25, 2016

Publications of Results:

Bradley JC, Bradley RH, McCartney DL, Mannis MJ. Serum growth factor analysis in dry eye syndrome. Clin Exp Ophthalmol. 2008 Nov;36(8):717-20. doi: 10.1111/j.1442-9071.2008.01895.x.

Research in dry eye: report of the Research Subcommittee of the International Dry Eye WorkShop (2007). Ocul Surf. 2007 Apr;5(2):179-93. Review.

Bron AJ, Evans VE, Smith JA. Grading of corneal and conjunctival staining in the context of other dry eye tests. Cornea. 2003 Oct;22(7):640-50. Review.

Pflugfelder SC, Solomon A, Stern ME. The diagnosis and management of dry eye: a twenty-five-year review. Cornea. 2000 Sep;19(5):644-9. Review.

Fox RI, Chan R, Michelson JB, Belmont JB, Michelson PE. Beneficial effect of artificial tears made with autologous serum in patients with keratoconjunctivitis sicca. Arthritis Rheum. 1984 Apr;27(4):459-61.

Tsubota K, Goto E, Fujita H, Ono M, Inoue H, Saito I, Shimmura S. Treatment of dry eye by autologous serum application in Sjögren's syndrome. Br J Ophthalmol. 1999 Apr;83(4):390-5.

López-García JS, García-Lozano I, Rivas L, Martínez-Garchitorena J. [Use of autologous serum in ophthalmic practice]. Arch Soc Esp Oftalmol. 2007 Jan;82(1):9-20. Review. Spanish.

Rybickova I, Vesela V, Fales I, Skalicka P, Jirsova K. Apoptosis of conjunctival epithelial cells before and after the application of autologous serum eye drops in severe dry eye disease. Biomed Pap Med Fac Univ Palacky Olomouc Czech Repub. 2016 Jun;160(2):271-5. doi: 10.5507/bp.2016.001. Epub 2016 Feb 29.

Gao J, Schwalb TA, Addeo JV, Ghosn CR, Stern ME. The role of apoptosis in the pathogenesis of canine keratoconjunctivitis sicca: the effect of topical Cyclosporin A therapy. Cornea. 1998 Nov;17(6):654-63.

Ridder WH 3rd. Ciclosporin use in dry eye disease patients. Expert Opin Pharmacother. 2008 Dec;9(17):3121-8. doi: 10.1517/14656560802500613 .

Yüksel B, Bozdağ B, Acar M, Topaloğlu E. Evaluation of the effect of topical cyclosporine A with impression cytology in dry eye patients. Eur J Ophthalmol. 2010 Jul-Aug;20(4):675-9.

Vitali C, Bombardieri S, Jonsson R, Moutsopoulos HM, Alexander EL, Carsons SE, Daniels TE, Fox PC, Fox RI, Kassan SS, Pillemer SR, Talal N, Weisman MH; European Study Group on Classification Criteria for Sjögren's Syndrome. Classification criteria for Sjögren's syndrome: a revised version of the European criteria proposed by the American-European Consensus Group. Ann Rheum Dis. 2002 Jun;61(6):554-8. Review.

Schiffman RM, Christianson MD, Jacobsen G, Hirsch JD, Reis BL. Reliability and validity of the Ocular Surface Disease Index. Arch Ophthalmol. 2000 May;118(5):615-21.

Kojima T, Ishida R, Dogru M, Goto E, Matsumoto Y, Kaido M, Tsubota K. The effect of autologous serum eyedrops in the treatment of severe dry eye disease: a prospective randomized case-control study. Am J Ophthalmol. 2005 Feb;139(2):242-6.

Tananuvat N, Daniell M, Sullivan LJ, Yi Q, McKelvie P, McCarty DJ, Taylor HR. Controlled study of the use of autologous serum in dry eye patients. Cornea. 2001 Nov;20(8):802-6.

Leite SC, de Castro RS, Alves M, Cunha DA, Correa ME, da Silveira LA, Vigorito AC, de Souza CA, Rocha EM. Risk factors and characteristics of ocular complications, and efficacy of autologous serum tears after haematopoietic progenitor cell transplantation. Bone Marrow Transplant. 2006 Aug;38(3):223-7. Epub 2006 Jun 19.

Welder JD, Bakhtiari P, Djalilian AR. Limbitis secondary to autologous serum eye drops in a patient with atopic keratoconjunctivitis. Case Rep Ophthalmol Med. 2011;2011:576521. doi: 10.1155/2011/576521. Epub 2011 Dec 21.

McDonnell PJ, Schanzlin DJ, Rao NA. Immunoglobulin deposition in the cornea after application of autologous serum. Arch Ophthalmol. 1988 Oct;106(10):1423-5. Review.

Poon AC, Geerling G, Dart JK, Fraenkel GE, Daniels JT. Autologous serum eyedrops for dry eyes and epithelial defects: clinical and in vitro toxicity studies. Br J Ophthalmol. 2001 Oct;85(10):1188-97.

Geerling G, Maclennan S, Hartwig D. Autologous serum eye drops for ocular surface disorders. Br J Ophthalmol. 2004 Nov;88(11):1467-74. Review.

Cho YK, Huang W, Kim GY, Lim BS. Comparison of autologous serum eye drops with different diluents. Curr Eye Res. 2013 Jan;38(1):9-17. doi: 10.3109/02713683.2012.720340. Epub 2012 Aug 28.

Fischer KR, Opitz A, Böeck M, Geerling G. Stability of serum eye drops after storage of 6 months. Cornea. 2012 Nov;31(11):1313-8. doi: 10.1097/ICO.0b013e3182542085.

Jeng BH, Dupps WJ Jr. Autologous serum 50% eyedrops in the treatment of persistent corneal epithelial defects. Cornea. 2009 Dec;28(10):1104-8. doi: 10.1097/ICO.0b013e3181a2a7f6.

Kojima T, Higuchi A, Goto E, Matsumoto Y, Dogru M, Tsubota K. Autologous serum eye drops for the treatment of dry eye diseases. Cornea. 2008 Sep;27 Suppl 1:S25-30. doi: 10.1097/ICO.0b013e31817f3a0e.

Noble BA, Loh RS, MacLennan S, Pesudovs K, Reynolds A, Bridges LR, Burr J, Stewart O, Quereshi S. Comparison of autologous serum eye drops with conventional therapy in a randomised controlled crossover trial for ocular surface disease. Br J Ophthalmol. 2004 May;88(5):647-52.

Urzua CA, Vasquez DH, Huidobro A, Hernandez H, Alfaro J. Randomized double-blind clinical trial of autologous serum versus artificial tears in dry eye syndrome. Curr Eye Res. 2012 Aug;37(8):684-8. doi: 10.3109/02713683.2012.674609. Epub 2012 Jun 6.

Ding C, Walcott B, Keyser KT. Sympathetic neural control of the mouse lacrimal gland. Invest Ophthalmol Vis Sci. 2003 Apr;44(4):1513-20.

Stevenson W, Chauhan SK, Dana R. Dry eye disease: an immune-mediated ocular surface disorder. Arch Ophthalmol. 2012 Jan;130(1):90-100. doi: 10.1001/archophthalmol.2011.364. Review.

Sall K, Stevenson OD, Mundorf TK, Reis BL. Two multicenter, randomized studies of the efficacy and safety of cyclosporine ophthalmic emulsion in moderate to severe dry eye disease. CsA Phase 3 Study Group. Ophthalmology. 2000 Apr;107(4):631-9. Erratum in: Ophthalmology 2000 Jul;107(7):1220.

Kunert KS, Tisdale AS, Gipson IK. Goblet cell numbers and epithelial proliferation in the conjunctiva of patients with dry eye syndrome treated with cyclosporine. Arch Ophthalmol. 2002 Mar;120(3):330-7. Erratum in: Arch Ophthalmol 2002 Aug;120(8):1099.

Kim EC, Choi JS, Joo CK. A comparison of vitamin a and cyclosporine a 0.05% eye drops for treatment of dry eye syndrome. Am J Ophthalmol. 2009 Feb;147(2):206-213.e3. doi: 10.1016/j.ajo.2008.08.015. Epub 2008 Oct 9.

Demiryay E, Yaylali V, Cetin EN, Yildirim C. Effects of topical cyclosporine a plus artificial tears versus artificial tears treatment on conjunctival goblet cell density in dysfunctional tear syndrome. Eye Contact Lens. 2011 Sep;37(5):312-5. doi: 10.1097/ICL.0b013e31822563be.

Stonecipher K, Perry HD, Gross RH, Kerney DL. The impact of topical cyclosporine A emulsion 0.05% on the outcomes of patients with keratoconjunctivitis sicca. Curr Med Res Opin. 2005 Jul;21(7):1057-63.

Barber LD, Pflugfelder SC, Tauber J, Foulks GN. Phase III safety evaluation of cyclosporine 0.1% ophthalmic emulsion administered twice daily to dry eye disease patients for up to 3 years. Ophthalmology. 2005 Oct;112(10):1790-4.

Behrens A, Doyle JJ, Stern L, Chuck RS, McDonnell PJ, Azar DT, Dua HS, Hom M, Karpecki PM, Laibson PR, Lemp MA, Meisler DM, Del Castillo JM, O'Brien TP, Pflugfelder SC, Rolando M, Schein OD, Seitz B, Tseng SC, van Setten G, Wilson SE, Yiu SC; Dysfunctional tear syndrome study group. Dysfunctional tear syndrome: a Delphi approach to treatment recommendations. Cornea. 2006 Sep;25(8):900-7.

Toshida H, Nguyen DH, Beuerman RW, Murakami A. Neurologic evaluation of acute lacrimomimetic effect of cyclosporine in an experimental rabbit dry eye model. Invest Ophthalmol Vis Sci. 2009 Jun;50(6):2736-41. doi: 10.1167/iovs.08-1880. Epub 2009 Feb 14.

Mah F, Milner M, Yiu S, Donnenfeld E, Conway TM, Hollander DA. PERSIST: Physician's Evaluation of Restasis(®) Satisfaction in Second Trial of topical cyclosporine ophthalmic emulsion 0.05% for dry eye: a retrospective review. Clin Ophthalmol. 2012;6:1971-6. doi: 10.2147/OPTH.S30261. Epub 2012 Nov 28.

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