Does Oral Acetaminophen Lower Intraocular Pressure?
Primary Purpose
Glaucoma
Status
Completed
Phase
Early Phase 1
Locations
United States
Study Type
Interventional
Intervention
Acetaminophen
Sponsored by

About this trial
This is an interventional treatment trial for Glaucoma
Eligibility Criteria
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
Sites / Locations
- Johns Hopkins - The Wilmer Eye Institute
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Acetaminophen
Arm Description
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.
Outcomes
Primary Outcome Measures
Lowering Eye Pressure
Eye pressure will be measured by using an IOP applanation tonometer seven days after the patient has stopped the medication.
Secondary Outcome Measures
Full Information
NCT ID
NCT02366065
First Posted
January 28, 2015
Last Updated
June 3, 2016
Sponsor
Johns Hopkins University
1. Study Identification
Unique Protocol Identification Number
NCT02366065
Brief Title
Does Oral Acetaminophen Lower Intraocular Pressure?
Official Title
Does Oral Acetaminophen Lower Intraocular Pressure?
Study Type
Interventional
2. Study Status
Record Verification Date
June 2016
Overall Recruitment Status
Completed
Study Start Date
January 2015 (undefined)
Primary Completion Date
May 2016 (Actual)
Study Completion Date
May 2016 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Johns Hopkins University
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
- Lowering intraocular pressure is the only proven treatment for glaucoma. Medications, almost always in the form of eye drops, are a mainstay for lowering intraocular pressure. Eye drops have the disadvantage of being difficult to administer and can have adverse effects on the surface of the eye and the surrounding tissues. Lowering intraocular pressure can be accomplished with oral carbonic anhydrase inhibitors, but the many systemic side effects of these agents relegates them to drugs of last resort. Therefore, an effective, well-tolerated, oral agent would be an important addition to the treatment of glaucoma. The hypothesis is that oral acetaminophen can lower intraocular pressure to a clinically significant degree in a dosing regimen that is both safe and convenient. The research is important because acetaminophen is inexpensive, available over-the-counter, and has a well known safety and side effect profile.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Glaucoma
7. Study Design
Primary Purpose
Treatment
Study Phase
Early Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
11 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Acetaminophen
Arm Type
Experimental
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
Acetaminophen
Other Intervention Name(s)
tylenol
Intervention Description
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.
Primary Outcome Measure Information:
Title
Lowering Eye Pressure
Description
Eye pressure will be measured by using an IOP applanation tonometer seven days after the patient has stopped the medication.
Time Frame
7 days
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Henry D Jampel, MD
Organizational Affiliation
Johns Hopkins University - Wilmer Eye Institute
Official's Role
Principal Investigator
Facility Information:
Facility Name
Johns Hopkins - The Wilmer Eye Institute
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21009
Country
United States
12. IPD Sharing Statement
Citations:
PubMed Identifier
23390358
Citation
Mohamed N, Meyer D. Intraocular pressure-lowering effect of oral paracetamol and its in vitro corneal penetration properties. Clin Ophthalmol. 2013;7:219-27. doi: 10.2147/OPTH.S38473. Epub 2013 Jan 30.
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Does Oral Acetaminophen Lower Intraocular Pressure?
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