Nasal Steroids in Controlled Glaucoma

This study has been completed.
Sponsor:
Collaborator:
Glaucoma Research Society of Canada
Information provided by:
University Health Network, Toronto
ClinicalTrials.gov Identifier:
NCT00775489
First received: October 16, 2008
Last updated: January 4, 2011
Last verified: October 2008

October 16, 2008
January 4, 2011
January 2010
July 2010   (final data collection date for primary outcome measure)
Statistical analysis of associations between nasal corticosteroid use and elevated IOP [ Time Frame: : 6 weeks from the beginning of treatment or IOP change by ≥ 20%. ] [ Designated as safety issue: Yes ]
Same as current
Complete list of historical versions of study NCT00775489 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
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Nasal Steroids in Controlled Glaucoma
The Effect of Beclomethasone Nasal Spray on Intraocular Pressure in Ocular Hypertension or Controlled Glaucoma

Patients that have consented to participate in the study will be randomly assigned to one of two groups: control group or nasal steroid group. Patients in the control group will receive normal saline inhaler. Patients in the study group will receive steroid inhaler Follow-up visits are: baseline and weeks 2, 4, 6 after starting the spray. Intraocular pressure will be recorded on all visits.

Systemic and topical ophthalmic steroids have long been associated with ocular effects, such as glaucoma or cataracts. Periocular steroid injections and steroids applied to periocular skin have also been reported to increase intraocular pressure (IOP) and raised IOP is the major risk factor for glaucoma. Approximately 18 to 36% of the general population are corticosteroid responders. This response is increased to 46 to 92% in patients with primary open-angle glaucoma (POAG).

Allergic rhinitis affects up to 30% of adults and 40% of children in the United States. Topical nasal steroids are the most effective treatment option.Nonallergic rhinitis is a common disease that affects approximately 17 million persons in the United States; approximately 22 million have a combination of allergic and nonallergic rhinitis.Topical nasal steroids have demonstrated efficacy in the treatment of nonallergic rhinitis and are considered first-line empiric therapy.With the perceived safety of nasal steroids, their use for the treatment of upper respiratory allergy has become more common.However, inhaled and nasal steroids might be absorbed systemically. Although the systemic absorption of inhaled and nasal steroids has been established, the clinically relevant ocular side effects are poorly defined. 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. Similarly, a large case-control study in 1997 cases suggested that the presence of nasal steroid use in patients with newly diagnosed glaucoma or OHT versus nonglaucomatous patients was not statistically significant (odds ratio, 1.02; 95% CI, 0.59-1.77). However, the number of patients taking continuous high-dose nasal steroids was too small for statistical analysis. In 1998, a small prospective study of 26 non-glaucomatous patients revealed no evidence of OHT or cataracts after prolonged use of nasal steroids after endoscopic sinus surgery (mean follow-up, 8.8 ± 3.6 months; range, 3-19 months). A study of 61 patients with seasonal allergic rhinitis taking nasal fluticasone for 1 year showed no increased risk for glaucoma.However, no information was described regarding their glaucoma risk status before steroid use in this study. Six cases of increased IOP associated with combined nasal and inhaled steroid use in non-glaucomatous patients have been reported.

Considering the large number of patients on nasal steroids; It is surprising that no one has investigated if nasal steroid use is contraindicated in glaucoma patients.

Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Intraocular Pressure
  • Drug: Nasal steroid Beclomethasone
    Beclomethasone nasal steroids to be given to a very well controlled glaucoma patients to find if this normal dose will lead to increase in intraocular pressure up to 20% where the study will be stopped at this point.
    Other Name: Beconase
  • Drug: Saline
    control group will receive normal saline inhaler
    Other Name: Saline
  • Active Comparator: 1
    Steroid nasal spray (beclomethasone)
    Intervention: Drug: Nasal steroid Beclomethasone
  • Placebo Comparator: 2
    Normal saline nasal spray
    Intervention: Drug: Saline
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
19
July 2010
July 2010   (final data collection date for primary outcome measure)

Inclusion criteria included the following:

  • age 18 to 85 years inclusive
  • OHT or mild to moderate POAG with cup-disc ratio of less than 0.8 vertically and mean deviation of less than −12.00 dB on Humphrey perimetry
  • well controlled disease defined by IOP being at target and no visual field or disc progression for a minimum of 6 months

Exclusion criteria included the following:

  • any form of steroid medication use within the last 6 weeks
  • previous intra-ocular or refractive surgery
  • no light perception vision.

Patients with or without rhinitis (allergic/ non-allergic/ mixed), with rhinitis defined as allergies and/ or nasal congestion present for greater than one year, were eligible.

Both
18 Years to 85 Years
No
Contact information is only displayed when the study is recruiting subjects
Canada
 
NCT00775489
UHNToronto001
No
Graham Trope / Professor, University of Toronto
University Health Network, Toronto
Glaucoma Research Society of Canada
Principal Investigator: Graham Trope, Professor University Health Network, Toronto
University Health Network, Toronto
October 2008

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP