Inhaled Corticosteroids: Effect on Intraocular Pressure in Patients With Controlled Glaucoma
NCT ID: NCT02338362
Last Updated: 2019-05-03
Study Results
Results available
Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.
View full resultsBasic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
Recruitment Status
COMPLETED
Clinical Phase
PHASE4
Total Enrollment
22 participants
Study Classification
INTERVENTIONAL
Study Start Date
2014-09-30
Study Completion Date
2015-02-28
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
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.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Ocular Pressure in Steroid-treated Dermatology Patients
NCT01759914
Topical Corticosteroid-treated Dermatology Patients
Intra-ocular Pressure
TERMINATED
Ocular Hypertension Treatment Study (OHTS)
NCT00000125
Ocular Hypertension
Glaucoma
COMPLETED
PHASE3
Changes in Eye Pressure and Anterior Chamber Depth With Oral Endothelin Antagonist Therapy
NCT00452283
Glaucoma
Pulmonary Hypertension
COMPLETED
IOP Fluctuations in Patients With Sleep Apnea With or Without Primary Open Angle Glaucoma Using Positive Airway Pressure
NCT01560975
Sleep Apnea, Obstructive
Primary Open-angle Glaucoma
COMPLETED
NA
IOP Reduction After Anecortave Acetate Injection in Glaucoma Patients
NCT00533962
Glaucoma
Intraocular Pressure
UNKNOWN
NA
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Systemic and topical ophthalmic steroids have long been associated with ocular effects, such as glaucoma or cataracts.\[Alfano JE; Bernstein HN et al. 1962; Bernstein HN et al. 1963; Becker B and Mills DW in Arch Ophthalm 1963; Becker B and Mills DW in JAMA 1963; Armaly MF 1963 (1); Armaly MF 1963 (2); and Buckley RJ\] Periocular steroid injections \[Herschler J; Kalina RE\] and steroids applied to periocular skin \[Aggarwal RK et al.\] have also been reported to increase intraocular pressure (IOP) and raised IOP is the major risk factor for glaucoma.
Ocular hypertension (OHT) is defined as an IOP above 21mmHg in one or both eyes without detectable glaucomatous damage. Primary open-angle glaucoma (POAG) is a chronic and progressive optic neuropathy of unknown etiology characterized by disc cupping, and often associated with visual field defects and elevated IOP. This disease is one of the leading causes of blindness worldwide.\[Kwon YH et al.\] Approximately 18% to 36% of the general population are corticosteroid responders. This response is increased to 46% to 92% in patients with POAG.\[Tripathi RC et al.\] Asthma is the most common chronic respiratory illness in Canada, affecting approximately 10% of the population. For the majority of these patients, long-term inhaled corticosteroids (ICS) are standard of care to prevent acute asthma exacerbations.\[Kim H and Mazza J\] Although the systemic absorption of inhaled and nasal steroids has been established, the clinically relevant ocular side effects are poorly defined. \[Cave A et al.; Allen DB et al.\] A large prospective study in 1995 by Samiy et al reported no statistically significant increase of IOP in 187 patients without glaucoma taking inhaled steroids for various pulmonary conditions.\[Samiy N et al.\] However, six cases of increased IOP associated with combined nasal and inhaled steroid use in non-glaucomatous patients have been reported. \[Dreyer EB; Desnoeck M et al.; Opatowsky I et al.\] A large case-control study in 1997 suggested that current users of high doses of ICS prescribed regularly for 3 or more months were at increased risk of OHT or OAG (OR 1.44; 95% CI 1.01-2.06).\[Garbe E et al.\] In contrast, Gozalez et al. conducted a nested case-control study in 2010 with Quebec data which showed current and continuous use of ICS did not result in increased risk of glaucoma or raised IOP requiring treatment.\[Gonzalez AV et al.\] Similarly, Duh et al. reported no association between inhaled budesonide daily therapy and increased IOP in 1255 asthmatic patients.\[Duh MS et al.\] Further, a prospective population-based cohort study published in 2012 suggested no association between the development of OAG and ICS in the elderly.\[Marcus MW et al.\] In 2013, our group published a randomized double-masked controlled trial that showed no evidence of IOP elevation after 6 weeks use of beclomethasone nasal spray in 19 patients with OHT and POAG.\[Yuen D et al.\] The purpose of the current study protocol would be to extend the study to investigate ICS in the same patient population.
To date, the effect of inhaled corticosteroids in those with pre-existing OHT or POAG remains uncertain. Considering the large number of patients on inhaled steroids, investigating the use of inhaled steroid in glaucoma patients could have significant clinical impact. This study was designed to evaluate the effect of inhaled fluticasone propionate on intraocular pressure (IOP) in patients with OHT or controlled open-angle glaucoma (OAG).
Patient randomization was performed by an independent Research Coordinator in a separate physical space and kept sealed from the principal study investigators, who assessed and recorded outcome measures, until the completion of study data collection. IOP was measured in a masked fashion, using a second observer to record values. Two measurements within 1 mmHg were averaged for each data point. With a sample size of 8 patients per interventional arm, the study is powered at 0.80 to detect an elevation of 3.2 mmHg (≥20%) from mean, assuming a standard deviation of 2.5 mmHg. Baseline data will be compared between groups using the student's t test and Fisher exact test. A 2-sided p value of \<0.05 will be considered statistically significant. The primary outcome measure (mean IOP) will be assessed using a 1-sided Student t test.
Ocular hypertension (OHT) is defined as an IOP above 21mmHg in one or both eyes without detectable glaucomatous damage. Primary open-angle glaucoma (POAG) is a chronic and progressive optic neuropathy of unknown etiology characterized by disc cupping, and often associated with visual field defects and elevated IOP. This disease is one of the leading causes of blindness worldwide.\[Kwon YH et al.\] Approximately 18% to 36% of the general population are corticosteroid responders. This response is increased to 46% to 92% in patients with POAG.\[Tripathi RC et al.\] Asthma is the most common chronic respiratory illness in Canada, affecting approximately 10% of the population. For the majority of these patients, long-term inhaled corticosteroids (ICS) are standard of care to prevent acute asthma exacerbations.\[Kim H and Mazza J\] Although the systemic absorption of inhaled and nasal steroids has been established, the clinically relevant ocular side effects are poorly defined. \[Cave A et al.; Allen DB et al.\] A large prospective study in 1995 by Samiy et al reported no statistically significant increase of IOP in 187 patients without glaucoma taking inhaled steroids for various pulmonary conditions.\[Samiy N et al.\] However, six cases of increased IOP associated with combined nasal and inhaled steroid use in non-glaucomatous patients have been reported. \[Dreyer EB; Desnoeck M et al.; Opatowsky I et al.\] A large case-control study in 1997 suggested that current users of high doses of ICS prescribed regularly for 3 or more months were at increased risk of OHT or OAG (OR 1.44; 95% CI 1.01-2.06).\[Garbe E et al.\] In contrast, Gozalez et al. conducted a nested case-control study in 2010 with Quebec data which showed current and continuous use of ICS did not result in increased risk of glaucoma or raised IOP requiring treatment.\[Gonzalez AV et al.\] Similarly, Duh et al. reported no association between inhaled budesonide daily therapy and increased IOP in 1255 asthmatic patients.\[Duh MS et al.\] Further, a prospective population-based cohort study published in 2012 suggested no association between the development of OAG and ICS in the elderly.\[Marcus MW et al.\] In 2013, our group published a randomized double-masked controlled trial that showed no evidence of IOP elevation after 6 weeks use of beclomethasone nasal spray in 19 patients with OHT and POAG.\[Yuen D et al.\] The purpose of the current study protocol would be to extend the study to investigate ICS in the same patient population.
To date, the effect of inhaled corticosteroids in those with pre-existing OHT or POAG remains uncertain. Considering the large number of patients on inhaled steroids, investigating the use of inhaled steroid in glaucoma patients could have significant clinical impact. This study was designed to evaluate the effect of inhaled fluticasone propionate on intraocular pressure (IOP) in patients with OHT or controlled open-angle glaucoma (OAG).
Patient randomization was performed by an independent Research Coordinator in a separate physical space and kept sealed from the principal study investigators, who assessed and recorded outcome measures, until the completion of study data collection. IOP was measured in a masked fashion, using a second observer to record values. Two measurements within 1 mmHg were averaged for each data point. With a sample size of 8 patients per interventional arm, the study is powered at 0.80 to detect an elevation of 3.2 mmHg (≥20%) from mean, assuming a standard deviation of 2.5 mmHg. Baseline data will be compared between groups using the student's t test and Fisher exact test. A 2-sided p value of \<0.05 will be considered statistically significant. The primary outcome measure (mean IOP) will be assessed using a 1-sided Student t test.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Ocular Hypertension
Glaucoma, Open-Angle
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
Allocation Method
RANDOMIZED
Intervention Model
PARALLEL
Primary Study Purpose
OTHER
Blinding Strategy
QUADRUPLE
Participants
Caregivers
Investigators
Outcome Assessors
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Fluticasone
10 participants will be asked to use fluticasone propionate 250 µg metered-dose inhaler 1 puff twice-daily for 6 weeks.
Group Type
ACTIVE_COMPARATOR
Fluticasone propionate inhaler
Intervention Type
DRUG
fluticasone propionate 250 µg metered-dose inhaler
Saline placebo
10 participants will be asked to use a saline placebo metered-dose inhaler 1 puff twice-daily for 6 weeks.
Group Type
PLACEBO_COMPARATOR
Saline placebo inhaler
Intervention Type
DRUG
saline metered dose inhaler
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Fluticasone propionate inhaler
fluticasone propionate 250 µg metered-dose inhaler
Intervention Type
DRUG
Saline placebo inhaler
saline metered dose inhaler
Intervention Type
DRUG
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* 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)
* 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)
Exclusion Criteria
* 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
* 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
Minimum Eligible Age
18 Years
Maximum Eligible Age
85 Years
Eligible Sex
ALL
Accepts Healthy Volunteers
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
University Health Network, Toronto
OTHER
Sponsor Role
lead
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Graham E Trope
Toronto Western Hospital Glaucoma Service Co-Director
Responsibility Role
PRINCIPAL_INVESTIGATOR
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Graham E Trope, MD,PhD,FRCSC
Role: PRINCIPAL_INVESTIGATOR
University Health Network, Toronto Western Hospital
References
Explore related publications, articles, or registry entries linked to this study.
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.
Reference Type
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.
Reference Type
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.
Reference Type
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.
Reference Type
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.
Reference Type
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.
Reference Type
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.
Reference Type
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.
Reference Type
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.
Reference Type
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.
Reference Type
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.
Reference Type
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.
Reference Type
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.
Reference Type
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.
Reference Type
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.
Reference Type
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.
Reference Type
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.
Reference Type
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.
Reference Type
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.
Reference Type
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.
Reference Type
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.
Reference Type
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.
Reference Type
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.
Reference Type
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.
Reference Type
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.
Reference Type
BACKGROUND
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
13-6069-A
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.
Aqueous Suppressant Versus Aqueous Outflow on Ocular Blood Flow
NCT01308788
COMPLETED
Laser-1st vs Drops-1st for Glaucoma and Ocular Hypertension
NCT03395535
COMPLETED
PHASE4
Impact Post-operative Treatment on Intraocular Pressure Post-SLT on Patients With Primary Open-angle Glaucoma
NCT01058278
COMPLETED
NA
Survey of Patients Taking IOP-Lowering Eye Drops
NCT02384772
COMPLETED
Effects of Topical Low Dose Preservative-free Hydrocortisone on Intraocular Pressure
NCT04536129
COMPLETED
NA
A Study of Intraocular Pressure (IOP) Reduction in Newly Diagnosed Patients With Primary Open Angle Glaucoma (POAG) or Ocular Hypertension (OHT)
NCT01628614
COMPLETED
Intraoperative 5-fluorouracil Augmentation of Trabeculectomy
NCT06745856
COMPLETED
PHASE3
Trusopt and Cosopt; Ocular Perfusion Pressure and Blood Flow: New Long-term Prospective Data
NCT01145898
COMPLETED
Relationship Between 24-hour IOP Pattern and the 24-hour Blood Pressure Pattern in Patients With POAG
NCT01769521
COMPLETED
NA
Retinal Effects of Balance Goggles System in Glaucoma Balance Goggles System (BGS) in Patients With Glaucoma
NCT04035239
COMPLETED
PHASE1
Prospective Evaluation of Open-angle Glaucoma Subjects on Two Topical Hypotensive Medication Treated With Two iStents
NCT01252888
COMPLETED
PHASE4
Relationship Between Eye Pressure and Ganglion Cell Function in Eyes Receiving Latanoprost Versus Placebo
NCT01042665
COMPLETED
Effects of Non-Specific Endothelin-A Receptor Blockade on Ocular Blood Flow in Patients With Glaucoma
NCT00701597
COMPLETED
PHASE1
Prospective Evaluation of Open-Angle Glaucoma Subjects on One Topical Hypotensive Medication Treated With Two iStents
NCT01252862
COMPLETED
PHASE4
Different Glaucoma Treatments Effect on Intraocular Pressure Fluctuation With Postural Change in Eyes With Open-angle Glaucoma
NCT02868502
UNKNOWN
A Prospective Evaluation of Open-Angle Glaucoma Subjects on Two Topical Hypotensive Medications Treated With One Suprachoroidal Stent
NCT01252914
COMPLETED
PHASE4
The Role of Steroids Following Selective Laser Trabeculoplasty
NCT00406042
COMPLETED
NA
Prospective Randomized Study Comparing Ex-PRESS to Trabeculectomy
NCT01263561
COMPLETED
NA
Prophylactic Anecortave Acetate in Patients With a Retisert Implant
NCT00570479
COMPLETED
PHASE1
Optic Nerve Sheath Diameter in Retrobulbar Ultrasound as a Surrogate Measure for Intracranial Pressure Before and After Non-invasive Strategies
NCT03634176
COMPLETED
Evaluate the Safety and Effectiveness of iSTAR Medical's MINIject™ Implant for Lowering Intraocular Pressure (IOP) in Subjects With Primary Open-angle Glaucoma.
NCT05024695
ACTIVE_NOT_RECRUITING
NA
Efficacy of Selective Laser Trabeculoplasty in Pseudophakic Patients
NCT01467388
UNKNOWN
IOP Lowering Effect of PLT Versus SLT in Naiv OAG Patients
NCT01886456
UNKNOWN
NA
Effect of IOP Lowering on Progressive HM
NCT05850936
RECRUITING
NA