Inhaled Corticosteroids: Effect on Intraocular Pressure in Patients With Controlled Glaucoma

NCT02338362 | Completed Phase 4 Results

• 1 other identifier: 13-6069-A
• Study Type: interventional
• Target: 22
• Locations: 0 countries
• Sites: N/A

Brief 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.

Conditions

Ocular Hypertension; Glaucoma, Open-Angle

Keywords

Corticosteroids; Bronchodilator Agents; Intraocular Pressure

Outcome Measures

Primary Outcomes (1)

• Mean Intraocular Pressure

  Masked assessment of intraocular pressure using goldmann application tonometry. Mean of 2 measurements within 1 mmHg will be recorded.

  week 6

Secondary Outcomes (4)

• Mean Visual Acuity

  week 6

• Side Effects

  from baseline to week 6

• Intraocular Pressure Elevation >20% From Baseline

  within 6-week observation period

• Adherence

  Completion of study, up to 6 weeks

Study Arms (2)

Fluticasone

ACTIVE COMPARATOR

10 participants will be asked to use fluticasone propionate 250 µg metered-dose inhaler 1 puff twice-daily for 6 weeks.

Drug: Fluticasone propionate inhaler

Saline placebo

PLACEBO COMPARATOR

10 participants will be asked to use a saline placebo metered-dose inhaler 1 puff twice-daily for 6 weeks.

Drug: Saline placebo inhaler

Interventions

Fluticasone propionate inhaler DRUG

fluticasone propionate 250 µg metered-dose inhaler

Fluticasone

Saline placebo inhaler DRUG

saline metered dose inhaler

Saline placebo

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age 18 to 85 years, inclusive
• Mild-moderate open-angle glaucoma/ocular hypertension with cup:disc ratio \<0.85 vertically and humphrey visual field mean deviation \>-12.00 (BOTH EYES must meet this criteria for patient to be included)
• Glaucoma well-controlled, defined by IOP \< 21 mmHg and at target with no visual field/disc progression for at least 6 months (BOTH EYES must meet this criteria for patient to be included)

You may not qualify if:

• Any form of steroid medication use within the prior 6 weeks
• Any previous intra-ocular surgery or refractive surgery in the study eye
• no light perception (i.e. blindness) in either eye
• unwilling/unable to give consent
• unwilling to accept randomization
• patient potentially unavailable for follow-up visits

Sponsors & Collaborators

• University Health Network, Toronto: lead

Related Publications (25)

• 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.

  PMID: 14061602 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.

  PMID: 13967694 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.

  PMID: 13967695 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.

  PMID: 14078872 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.

  PMID: 14043096 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.

  PMID: 14078870 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.

  PMID: 14078871 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.

  PMID: 9988434 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.

  PMID: 5053696 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.

  PMID: 5783749 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.

  PMID: 8287990 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.

  PMID: 19279343 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.

  PMID: 10641955 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.

  PMID: 22165976 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.

  PMID: 10576291 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.

  PMID: 14515117 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.

  PMID: 8743219 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.

  PMID: 8232507 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.

  PMID: 11486469 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.

  PMID: 7862403 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.

  PMID: 9042844 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.

  PMID: 19887116 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.

  PMID: 11101175 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.

  PMID: 23150239 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.

  PMID: 21716127 BACKGROUND

MeSH Terms

Conditions

Ocular Hypertension; Glaucoma, Open-Angle

Condition Hierarchy (Ancestors)

Eye Diseases; Glaucoma

Results Point of Contact

• Title: Dr. Graham Trope
• Organization: Department of Ophthalmology and Vision Sciences, University of Toronto, Toronto, Ontario, Canada

graham.trope@uhn.ca

1-416-603-5117

Study Officials

• Graham E Trope, MD,PhD,FRCSC

  University Health Network, Toronto Western Hospital

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Toronto Western Hospital Glaucoma Service Co-Director

Study Record Dates

• First Submitted: December 2, 2014
• First Posted: January 14, 2015
• Study Start: September 1, 2014
• Primary Completion: February 1, 2015
• Study Completion: February 1, 2015
• Last Updated: May 3, 2019
• Results First Posted: May 3, 2019

Record last verified: 2019-04