Nasal Steroids in Controlled Glaucoma

NCT00775489 | Completed

• 1 other identifier: UHNToronto001
• Study Type: interventional
• Target: 19
• Locations: 1 country
• Sites: 1

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.

Conditions

Intraocular Pressure

Keywords

glaucoma, steroid, nasal

Outcome Measures

Primary Outcomes (1)

• Statistical analysis of associations between nasal corticosteroid use and elevated IOP

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

Study Arms (2)

1

ACTIVE COMPARATOR

Steroid nasal spray (beclomethasone)

Drug: Nasal steroid Beclomethasone

2

PLACEBO COMPARATOR

Normal saline nasal spray

Drug: Saline

Interventions

Nasal steroid Beclomethasone DRUG

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.

Also known as: Beconase

1

Saline DRUG

control group will receive normal saline inhaler

2

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• University Health Network, Toronto: lead
• Glaucoma Research Society of Canada: collaborator

Study Sites (1)

University of Toronto; Toronto Western Hospital

Toronto, Ontario, Canada

Location

MeSH Terms

Conditions

Glaucoma

Interventions

Beclomethasone; Sodium Chloride

Condition Hierarchy (Ancestors)

Ocular Hypertension; Eye Diseases

Intervention Hierarchy (Ancestors)

Pregnadienetriols; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Steroids, Chlorinated; Chlorides; Hydrochloric Acid; Chlorine Compounds; Inorganic Chemicals; Sodium Compounds

Study Officials

• Graham Trope, Professor

  University Health Network, Toronto

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: October 16, 2008
• First Posted: October 20, 2008
• Study Start: January 1, 2010
• Primary Completion: July 1, 2010
• Study Completion: July 1, 2010
• Last Updated: January 5, 2011

Record last verified: 2008-10

Locations

CA (1)