Phase 4
N=22
Inhaled Corticosteroids: Effect on Intraocular Pressure in Patients With Controlled Glaucoma
Ocular Hypertension · Glaucoma, Open-Angle
Bottom Line
View on ClinicalTrials.gov: NCT02338362 ↗Enrolled (actual)
22
Serious AEs
0.0%
Results posted
May 2019
Primary outcome: Primary: Mean Intraocular Pressure — 14.7; 14.8 mmHg
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 4
- Interventions
- Fluticasone propionate inhaler (Drug); Saline placebo inhaler (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- University Health Network, Toronto
- Primary completion
- Feb 2015
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Mean Intraocular Pressure |
14.7; 14.8 | — |
| SECONDARY Mean Visual Acuity |
0.15; 0.15 | — |
| SECONDARY Side Effects |
0; 0; 1; 1; 1; 0 | — |
| SECONDARY Intraocular Pressure Elevation >20% From Baseline |
1; 0; 9; 10 | — |
| SECONDARY Adherence |
93.6; 96.1 | — |
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.
Eligibility Criteria
Inclusion Criteria
- Age 18 to 85 years, inclusive
- Mild-moderate open-angle glaucoma/ocular hypertension with cup:disc ratio -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
Data sourced from ClinicalTrials.gov (NCT02338362). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.