Ocular Hypertension Clinical Trial
Official title:
The Effect of Inhaled Corticosteroids on Intraocular Pressure in Patients With Ocular Hypertension or Controlled Glaucoma.
Verified date | April 2019 |
Source | University Health Network, Toronto |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 22 |
Est. completion date | February 2015 |
Est. primary completion date | February 2015 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 85 Years |
Eligibility |
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 |
Country | Name | City | State |
---|---|---|---|
n/a |
Lead Sponsor | Collaborator |
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University Health Network, Toronto |
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* Note: There are 25 references in all — Click here to view all references
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Mean Intraocular Pressure | Masked assessment of intraocular pressure using goldmann application tonometry. Mean of 2 measurements within 1 mmHg will be recorded. | week 6 | |
Secondary | Mean Visual Acuity | best corrected logMAR visual acuity for each eye. 20/20 vision corresponds with a logMAR score of 0, while negative logMAR scores indicate better than 20/20 vision, values > 0.5 correspond with low vision, and values > 1.3 correspond with blindness. | week 6 | |
Secondary | Side Effects | subjective (reported) and objective (slit lamp examination) side-effects attributable to study medications | from baseline to week 6 | |
Secondary | Intraocular Pressure Elevation >20% From Baseline | Participants with 2 consecutive intraocular pressure measurements exceeding 20% increase from baseline were discontinued from study. | within 6-week observation period | |
Secondary | Adherence | Adherence was calculated from self-reported study diaries and correlated to a counter that measured number of inhaled puffs built into the placebo metered-dose inhalers | Completion of study, up to 6 weeks |
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