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Nasal Steroids in Controlled Glaucoma (nasal steroids)
This study is not yet open for participant recruitment.
Verified by University Health Network, Toronto, October 2008
Sponsors and Collaborators: University Health Network, Toronto
Glaucoma Research Society of Canada
Information provided by: University Health Network, Toronto
ClinicalTrials.gov Identifier: NCT00775489
  Purpose

Patients that have consented to participate in the study will be randomly assigned to one of two groups: control group or nasal steroid group. Assignment will be stratified by surgeon. Patients in the control group will receive normal saline inhaler. Patients in the study group will receive steroid inhaler Patients will be seen on The need for continued follow-up and timely visits will be stressed to the patient during the informed consent process and throughout the study. Time windows for follow-up visits are: recruitment day (45-0 pre-treatment),day 0 (starting treatment day), 1 week , 2 weeks , 4 weeks, 6 week . Intraocular pressures will be recorded on all visits.


Condition Intervention
Intraocular Pressure
Drug: Nasal steroid Fluticasone
Drug: Saline

Genetics Home Reference related topics: early-onset glaucoma
MedlinePlus related topics: Glaucoma
Drug Information available for: Fluticasone Fluticasone propionate
U.S. FDA Resources
Study Type: Interventional
Study Design: Treatment, Non-Randomized, Double Blind (Subject, Investigator), Uncontrolled, Single Group Assignment, Safety Study
Official Title: Nasal Steroids: Effect on Intraocular Pressure in Patients With Controlled Glaucoma

Further study details as provided by University Health Network, Toronto:

Primary Outcome Measures:
  • 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 ]

Estimated Enrollment: 20
Study Start Date: October 2008
Estimated Study Completion Date: December 2010
Estimated Primary Completion Date: December 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
1: Experimental Drug: Nasal steroid Fluticasone
Fluticasone nasal steroids to be given to a very well controlled glaucoma patients to find if this normal dose will lead to increase in iontraocular pressure up to 20% where the study will be stopped at this point.
2: Placebo Comparator Drug: Saline
control group will receive normal saline inhaler

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 skin11 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 alreported 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 nonglaucomatous 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 nonglaucomatous 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.

  Eligibility

Ages Eligible for Study:   18 Years to 85 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

All of the criteria listed below must be present in the study eye in order for the patient to be eligible for enrollment in the study.

  1. Age 18 to 85 years, inclusive.
  2. Glaucoma that is adequately controlled on tolerated medical therapy with intraocular pressure at target and no visual field or disc progression for at least two years.
  3. Mild to moderate POAG with cup-disc ratio less than 0.8 vertically and mean deviation of less than −12.00 on Humphrey perimetry.

    -

Exclusion Criteria:

If any of the following exclusion criteria are present in the study eye, the eye may not be entered into the study.

  1. Unwilling or unable to give consent or unwilling to accept randomization.
  2. Patient out of area and potentially unavailable for follow-up visits
  3. No light perception.
  4. Any previous intra-ocular surgery.
  5. Post refractive surgery patient.
  6. Uncontrolled glaucoma or advanced POAG -
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00775489

Contacts
Contact: University of Toronto; Toronto Western Hospital GE Trope, PhD, FRCSC (416) 603-5317 Graham.Trope@uhn.on.ca
Contact: University of Toronto; Toronto Western Hospital YM Buys, MD, FRCSC (416) 603-5682 y.buys@utoronto.ca

Locations
Canada, Ontario
University of Toronto; Toronto Western Hospital
Toronto, Ontario, Canada
Sponsors and Collaborators
University Health Network, Toronto
Glaucoma Research Society of Canada
  More Information

Responsible Party: University of Toronto ( Graham Trope / Professor )
Study ID Numbers: UHNToronto001
Study First Received: October 16, 2008
Last Updated: October 17, 2008
ClinicalTrials.gov Identifier: NCT00775489  
Health Authority: United States: Institutional Review Board

Keywords provided by University Health Network, Toronto:
glaucoma,steroid,nasal

Study placed in the following topic categories:
Glaucoma
Eye Diseases
Fluticasone
Hypertension
Ocular Hypertension

Additional relevant MeSH terms:
Anti-Inflammatory Agents
Respiratory System Agents
Autonomic Agents
Therapeutic Uses
Physiological Effects of Drugs
Anti-Asthmatic Agents
Anti-Allergic Agents
Peripheral Nervous System Agents
Dermatologic Agents
Bronchodilator Agents
Pharmacologic Actions

ClinicalTrials.gov processed this record on January 16, 2009