- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02366065
Does Oral Acetaminophen Lower Intraocular Pressure?
Study Overview
Detailed Description
The study design is prospective case series. Before treatment, study subjects will have their intraocular pressure measured at 8 am, 10 am, 12 pm and 4 pm. They will then take acetaminophen 650 mg qid for 7 days and the intraocular pressures again measured at 8 am, 10 am, 12 pm, and 4 pm. Subjects will then stop the acetaminophen and return one week later for one more set of intraocular pressure measurements at 8 am, 10 am, 12 pm, and 4 pm. The subjects will receive a reminder, by phone or text message, the day before each visit. Although measurement of intraocular pressure is part of routine clinical care, multiple intraocular pressure measurements over the course of three different days is not.
-- The subjects will not be masked to the intervention. The person measuring the intraocular pressure will be unaware of the purpose of the study, and hence there should be no bias in the measurement of the main outcome measure, intraocular pressure.
- Treatment will occur for 7 days only, and during that time we will not know if the treatment has been successful in lowering the intraocular pressure. The only basis upon which a participant would be removed would be if he or she reported adverse effects from the study medication before the one week.
- The rationale for choosing acetaminophen is that there are data that it may be effective in lowering intraocular pressure. The dose chosen for this study (650 mg qid), is a dosing regimen that is commonly used for the treatment of pain, and is below the maximum recommended daily dose of 3 gm/day. If this dosing scheme does NOT lower intraocular pressure, further investigations are not planned; if it does lower intraocular pressure, further studies will be performed to find the lowest effective dose.
- Acetaminophen has a several decades long safety record as an over the counter medication for the treatment of pain. The dose and route of administration proposed is standard. Many of the participants will likely have used acetaminophen in the past.
Study Type
Enrollment (Actual)
Phase
- Early Phase 1
Contacts and Locations
Study Locations
-
-
Maryland
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Baltimore, Maryland, United States, 21009
- Johns Hopkins - The Wilmer Eye Institute
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- not on intraocular pressure lowering medications for at least 6 weeks in either eye.
- IOP above 22 mm Hg and below 35 mm Hg in at least one eye. The eye with the higher IOP will be the study eye
Exclusion Criteria:
- using acetaminophen
- history of hepatic disease either reported by the patient or documented in the patient's medical record
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Acetaminophen
study subjects will have their intraocular pressure measured at 8 am, 10 am, 12 pm and 4 pm.
They will then take acetaminophen 650 mg qid for 7 days and the intraocular pressures again measured at 8 am, 10 am, 12 pm, and 4 pm.
Subjects will then stop the acetaminophen and return one week later for one more set of intraocular pressure measurements at 8 am, 10 am, 12 pm, and 4 pm.
|
Before treatment, study subjects will have their intraocular pressure measured at 8 am, 10 am, 12 pm and 4 pm.
They will then take acetaminophen 650 mg qid for 7 days and the intraocular pressures again measured at 8 am, 10 am, 12 pm, and 4 pm.
Subjects will then stop the acetaminophen and return one week later for one more set of intraocular pressure measurements at 8 am, 10 am, 12 pm, and 4 pm.
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Lowering Eye Pressure
Time Frame: 7 days
|
Eye pressure will be measured by using an IOP applanation tonometer seven days after the patient has stopped the medication.
|
7 days
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Henry D Jampel, MD, Johns Hopkins University - Wilmer Eye Institute
Publications and helpful links
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- CIR00006973
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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