Nasal Steroids in Controlled Glaucoma

January 4, 2011 updated by: University Health Network, Toronto

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

19

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Canada
    • Ontario
      • Toronto, Ontario, Canada
        • University of Toronto; Toronto Western Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

14 years to 81 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Single Group Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: 1
Steroid nasal spray (beclomethasone)
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 Names:
  • Beconase
Placebo Comparator: 2
Normal saline nasal spray
Drug: Saline
control group will receive normal saline inhaler

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
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%.
: 6 weeks from the beginning of treatment or IOP change by ≥ 20%.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Health Network, Toronto

Collaborators

Glaucoma Research Society of Canada

Investigators

  • Principal Investigator: Graham Trope, Professor, University Health Network, Toronto

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2010

Primary Completion (Actual)

July 1, 2010

Study Completion (Actual)

July 1, 2010

Study Registration Dates

First Submitted

October 16, 2008

First Submitted That Met QC Criteria

October 17, 2008

First Posted (Estimate)

October 20, 2008

Study Record Updates

Last Update Posted (Estimate)

January 5, 2011

Last Update Submitted That Met QC Criteria

January 4, 2011

Last Verified

October 1, 2008

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • UHNToronto001

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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