Inhaled Corticosteroids: Effect on Intraocular Pressure in Patients With Controlled Glaucoma

• Status: Completed
• Trial end date: 2015-02-01
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this study is to determine whether a commonly prescribed orally inhaled corticosteroid treatment will induce a clinically meaningful elevation in intraocular pressure, when administered to patients with ocular hypertension (OHT) or open-angle glaucoma (OAG). Based on the response to high-dose corticosteroids, this patient group is more likely than the normal population to demonstrate this adverse effect.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University Health Network, Toronto
• Treatments: Fluticasone; Xhance

Criteria

Inclusion Criteria:

• Age 18 to 85 years, inclusive

• Mild-moderate open-angle glaucoma/ocular hypertension with cup:disc ratio <0.85 vertically and humphrey visual field mean deviation >-12.00 (BOTH EYES must meet this criteria for patient to be included)

• Glaucoma well-controlled, defined by IOP < 21 mmHg and at target with no visual field/disc progression for at least 6 months (BOTH EYES must meet this criteria for patient to be included)

Exclusion Criteria:

• Any form of steroid medication use within the prior 6 weeks

• Any previous intra-ocular surgery or refractive surgery in the study eye

• no light perception (i.e. blindness) in either eye

• unwilling/unable to give consent

• unwilling to accept randomization

• patient potentially unavailable for follow-up visits