drugset / Trial / NCT04075227
Topical 0.2% Loteprednol Etabonate vs. Topical 0.1% Dexamethasone in Impending Recurrent Pterygium
RandomizedParallel-groupOpen-labelTreatment
Summary
The objective of this study was to evaluate the efficacy of topical 0.2% loteprednol etabonate, a 'soft steroid', compared with topical 0.1% dexamethasone, which is widely used in postoperative pterygium excision to prevent the recurrence of pterygium. If 0.2% loteprednol etabonate is non-inferior in efficacy compared with 0.1% dexamethasone, it may be used postoperatively in pterygium excision patients with the benefit of a low incidence of ocular hypertension or secondary glaucoma.
Timeline
- Start
- 2015-10-16
- Primary completion
- 2019-03-02
- Completion
- 2019-03-02
Publications
- Results Mahar PS, Manzar N. Pterygium recurrence related to its size and corneal involvement. J Coll Physicians Surg Pak. 2013 Feb;23(2):120-3.
- Results Sherwin JC, Hewitt AW, Kearns LS, Griffiths LR, Mackey DA, Coroneo MT. The association between pterygium and conjunctival ultraviolet autofluorescence: the Norfolk Island Eye Study. Acta Ophthalmol. 2013 Jun;91(4):363-70. doi: 10.1111/j.1755-3768.2011.02314.x. Epub 2011 Dec 16.
- Results Yaisawang S, Piyapattanakorn P. Role of post-operative topical corticosteroids in recurrence rate after pterygium excision with conjunctival autograft. J Med Assoc Thai. 2003 Jun;86 Suppl 2:S215-23.
- Results Hirst LW. The treatment of pterygium. Surv Ophthalmol. 2003 Mar-Apr;48(2):145-80. doi: 10.1016/s0039-6257(02)00463-0.
- Results Kucukerdonmez C, Akova YA, Altinors DD. Comparison of conjunctival autograft with amniotic membrane transplantation for pterygium surgery: surgical and cosmetic outcome. Cornea. 2007 May;26(4):407-13. doi: 10.1097/ICO.0b013e318033b3d4.
- Results Pikkel J, Porges Y, Ophir A. Halting pterygium recurrence by postoperative 5-fluorouracil. Cornea. 2001 Mar;20(2):168-71. doi: 10.1097/00003226-200103000-00011.
- Results Anguria P, Ntuli S, Carmichael T. Young patient's age determines pterygium recurrence after surgery. Afr Health Sci. 2014 Mar;14(1):72-6. doi: 10.4314/ahs.v14i1.11.
- Results Han SB, Jeon HS, Kim M, Lee SJ, Yang HK, Hwang JM, Kim KG, Hyon JY, Wee WR. Risk Factors for Recurrence After Pterygium Surgery: An Image Analysis Study. Cornea. 2016 Aug;35(8):1097-103. doi: 10.1097/ICO.0000000000000853.
- Results Olusanya BA, Ogun OA, Bekibele CO, Ashaye AO, Baiyeroju AM, Fasina O, Ogundipe AO, Ibrahim AO. Risk factors for pterygium recurrence after surgical excision with combined conjunctival autograft (CAG) and intraoperative antimetabolite use. Afr J Med Med Sci. 2014 Mar;43(1):35-40.
- Results Nuzzi R, Tridico F. How to minimize pterygium recurrence rates: clinical perspectives. Clin Ophthalmol. 2018 Nov 19;12:2347-2362. doi: 10.2147/OPTH.S186543. eCollection 2018.
- Results Kim KW, Kim JC. Current approaches and future directions in the management of pterygium. Int J Ophthalmol. 2018 May 18;11(5):709-711. doi: 10.18240/ijo.2018.05.01. eCollection 2018.
- Results Prabhasawat P, Tesavibul N, Leelapatranura K, Phonjan T. Efficacy of subconjunctival 5-fluorouracil and triamcinolone injection in impending recurrent pterygium. Ophthalmology. 2006 Jul;113(7):1102-9. doi: 10.1016/j.ophtha.2006.02.026. Epub 2006 May 26.
- Results Makornwattana M, Suphachearaphan W. Incidence of steroid induced-ocular hypertension in postoperative pterygium excision. J Med Assoc Thai. 2015 Mar;98 Suppl 2:S151-7.
- Results Bodor N, Buchwald P. Soft drug design: general principles and recent applications. Med Res Rev. 2000 Jan;20(1):58-101. doi: 10.1002/(sici)1098-1128(200001)20:13.0.co;2-x.
- Results Comstock TL, Sheppard JD. Loteprednol etabonate for inflammatory conditions of the anterior segment of the eye: twenty years of clinical experience with a retrometabolically designed corticosteroid. Expert Opin Pharmacother. 2018 Mar;19(4):337-353. doi: 10.1080/14656566.2018.1439920. Epub 2018 Mar 7.
- Results Sheppard JD, Comstock TL, Cavet ME. Impact of the Topical Ophthalmic Corticosteroid Loteprednol Etabonate on Intraocular Pressure. Adv Ther. 2016 Apr;33(4):532-52. doi: 10.1007/s12325-016-0315-8. Epub 2016 Mar 17.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Comparator | Dexamethasone | Small molecule | 0.1 % | Topical |
| Subject | Loteprednol Etabonate | Other / unclassified | 0.2 % | Topical |