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Nasal Steroids in Controlled Glaucoma

Primary Purpose

Intraocular Pressure

Status
Completed
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
Nasal steroid Beclomethasone
Saline
Sponsored by
University Health Network, Toronto
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Intraocular Pressure focused on measuring glaucoma, steroid, nasal

Eligibility Criteria

18 Years - 85 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • University of Toronto; Toronto Western Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

1

2

Arm Description

Steroid nasal spray (beclomethasone)

Normal saline nasal spray

Outcomes

Primary Outcome Measures

Statistical analysis of associations between nasal corticosteroid use and elevated IOP

Secondary Outcome Measures

Full Information

First Posted
October 16, 2008
Last Updated
January 4, 2011
Sponsor
University Health Network, Toronto
Collaborators
Glaucoma Research Society of Canada
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1. Study Identification

Unique Protocol Identification Number
NCT00775489
Brief Title
Nasal Steroids in Controlled Glaucoma
Official Title
The Effect of Beclomethasone Nasal Spray on Intraocular Pressure in Ocular Hypertension or Controlled Glaucoma
Study Type
Interventional

2. Study Status

Record Verification Date
October 2008
Overall Recruitment Status
Completed
Study Start Date
January 2010 (undefined)
Primary Completion Date
July 2010 (Actual)
Study Completion Date
July 2010 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
University Health Network, Toronto
Collaborators
Glaucoma Research Society of Canada

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
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.
Detailed Description
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Intraocular Pressure
Keywords
glaucoma, steroid, nasal

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
19 (Actual)

8. Arms, Groups, and Interventions

Arm Title
1
Arm Type
Active Comparator
Arm Description
Steroid nasal spray (beclomethasone)
Arm Title
2
Arm Type
Placebo Comparator
Arm Description
Normal saline nasal spray
Intervention Type
Drug
Intervention Name(s)
Nasal steroid Beclomethasone
Other Intervention Name(s)
Beconase
Intervention Description
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.
Intervention Type
Drug
Intervention Name(s)
Saline
Intervention Description
control group will receive normal saline inhaler
Primary Outcome Measure Information:
Title
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%.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Graham Trope, Professor
Organizational Affiliation
University Health Network, Toronto
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Toronto; Toronto Western Hospital
City
Toronto
State/Province
Ontario
Country
Canada

12. IPD Sharing Statement

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Nasal Steroids in Controlled Glaucoma

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