drugset / Trial / NCT02338362
Inhaled Corticosteroids: Effect on Intraocular Pressure in Patients With Controlled Glaucoma
RandomizedParallel-groupQuadruple-blindOther
Summary
The purpose of this study is to determine whether a commonly prescribed orally inhaled corticosteroid treatment will induce a clinically meaningful elevation in intraocular pressure, when administered to patients with ocular hypertension (OHT) or open-angle glaucoma (OAG). Based on the response to high-dose corticosteroids, this patient group is more likely than the normal population to demonstrate this adverse effect.
Timeline
- Start
- 2014-09
- Primary completion
- 2015-02
- Completion
- 2015-02
Publications
- Background ALFANO JE. CHANGES IN THE INTRAOCULAR PRESSURE ASSOCIATED WITH SYSTEMIC STEROID THERAPY. Am J Ophthalmol. 1963 Aug;56:245-7. doi: 10.1016/0002-9394(63)91858-0. No abstract available.
- Background BERNSTEIN HN, SCHWARTZ B. Effects of long-term systemic steroids on ocular pressure and tonographic values. Arch Ophthalmol. 1962 Dec;68:742-53. doi: 10.1001/archopht.1962.00960030746009. No abstract available.
- Background BERNSTEIN HN, MILLS DW, BECKER B. Steroid-induced elevation of intraocular pressure. Arch Ophthalmol. 1963 Jul;70:15-8. doi: 10.1001/archopht.1963.00960050017005. No abstract available.
- Background BECKER B, MILLS DW. CORTICOSTEROIDS AND INTRAOCULAR PRESSURE. Arch Ophthalmol. 1963 Oct;70:500-7. doi: 10.1001/archopht.1963.00960050502012. No abstract available.
- Background BECKER B, MILLS DW. ELEVATED INTRAOCULAR PRESSURE FOLLOWING CORTICOSTEROID EYE DROPS. JAMA. 1963 Sep 14;185:884-6. doi: 10.1001/jama.1963.03060110088027. No abstract available.
- Background ARMALY MF. EFFECT OF CORTICOSTEROIDS ON INTRAOCULAR PRESSURE AND FLUID DYNAMICS. I. THE EFFECT OF DEXAMETHASONE IN THE NORMAL EYE. Arch Ophthalmol. 1963 Oct;70:482-91. doi: 10.1001/archopht.1963.00960050484010. No abstract available.
- Background ARMALY MF. EFFECT OF CORTICOSTEROIDS ON INTRAOCULAR PRESSURE AND FLUID DYNAMICS. II. THE EFFECT OF DEXAMETHASONE IN THE GLAUCOMATOUS EYE. Arch Ophthalmol. 1963 Oct;70:492-9. doi: 10.1001/archopht.1963.00960050494011. No abstract available.
- Background Buckley RJ. Allergic eye disease--a clinical challenge. Clin Exp Allergy. 1998 Dec;28 Suppl 6:39-43. doi: 10.1046/j.1365-2222.1998.0280s6039.x.
- Background Herschler J. Intractable intraocular hypertension induced by repository triamcinolone acetonide. Am J Ophthalmol. 1972 Sep;74(3):501-4. doi: 10.1016/0002-9394(72)90916-6. No abstract available.
- Background Kalina RE. Increased intraocular pressure following subconjunctival corticosteroid administration. Arch Ophthalmol. 1969 Jun;81(6):788-90. doi: 10.1001/archopht.1969.00990010790006. No abstract available.
- Background Aggarwal RK, Potamitis T, Chong NH, Guarro M, Shah P, Kheterpal S. Extensive visual loss with topical facial steroids. Eye (Lond). 1993;7 ( Pt 5):664-6. doi: 10.1038/eye.1993.152.
- Background Kwon YH, Fingert JH, Kuehn MH, Alward WL. Primary open-angle glaucoma. N Engl J Med. 2009 Mar 12;360(11):1113-24. doi: 10.1056/NEJMra0804630. No abstract available.
- Background Tripathi RC, Parapuram SK, Tripathi BJ, Zhong Y, Chalam KV. Corticosteroids and glaucoma risk. Drugs Aging. 1999 Dec;15(6):439-50. doi: 10.2165/00002512-199915060-00004.
- Background Kim H, Mazza J. Asthma. Allergy Asthma Clin Immunol. 2011 Nov 10;7 Suppl 1(Suppl 1):S2. doi: 10.1186/1710-1492-7-S1-S2.
- Background Cave A, Arlett P, Lee E. Inhaled and nasal corticosteroids: factors affecting the risks of systemic adverse effects. Pharmacol Ther. 1999 Sep;83(3):153-79. doi: 10.1016/s0163-7258(99)00019-4.
- Background Allen DB, Bielory L, Derendorf H, Dluhy R, Colice GL, Szefler SJ. Inhaled corticosteroids: past lessons and future issues. J Allergy Clin Immunol. 2003 Sep;112(3 Suppl):S1-40. doi: 10.1016/s0091-6749(03)01859-1.
- Background Samiy N, Walton DS, Dreyer EB. Inhaled steroids: effect on intraocular pressure in patients without glaucoma. Can J Ophthalmol. 1996 Apr;31(3):120-3.
- Background Dreyer EB. Inhaled steroid use and glaucoma. N Engl J Med. 1993 Dec 9;329(24):1822. doi: 10.1056/nejm199312093292420. No abstract available.
- Background Desnoeck M, Casteels I, Casteels K. Intraocular pressure elevation in a child due to the use of inhalation steroids--a case report. Bull Soc Belge Ophtalmol. 2001;(280):97-100.
- Background Opatowsky I, Feldman RM, Gross R, Feldman ST. Intraocular pressure elevation associated with inhalation and nasal corticosteroids. Ophthalmology. 1995 Feb;102(2):177-9. doi: 10.1016/s0161-6420(95)31039-1.
- Background Garbe E, LeLorier J, Boivin JF, Suissa S. Inhaled and nasal glucocorticoids and the risks of ocular hypertension or open-angle glaucoma. JAMA. 1997 Mar 5;277(9):722-7.
- Background Gonzalez AV, Li G, Suissa S, Ernst P. Risk of glaucoma in elderly patients treated with inhaled corticosteroids for chronic airflow obstruction. Pulm Pharmacol Ther. 2010 Apr;23(2):65-70. doi: 10.1016/j.pupt.2009.10.014. Epub 2009 Nov 1.
- Background Duh MS, Walker AM, Lindmark B, Laties AM. Association between intraocular pressure and budesonide inhalation therapy in asthmatic patients. Ann Allergy Asthma Immunol. 2000 Nov;85(5):356-61. doi: 10.1016/S1081-1206(10)62545-8.
- Background Marcus MW, Muskens RP, Ramdas WD, Wolfs RC, De Jong PT, Vingerling JR, Hofman A, Stricker BH, Jansonius NM. Corticosteroids and open-angle glaucoma in the elderly: a population-based cohort study. Drugs Aging. 2012 Dec;29(12):963-70. doi: 10.1007/s40266-012-0029-9.
- Background Yuen D, Buys YM, Jin YP, Alasbali T, Trope GE. Effect of beclomethasone nasal spray on intraocular pressure in ocular hypertension or controlled glaucoma. J Glaucoma. 2013 Feb;22(2):84-7. doi: 10.1097/IJG.0b013e3182254811.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Comparator | Fluticasone propionate | Other / unclassified | 250 ug | Inhaled |