Does Oral Acetaminophen Lower Intraocular Pressure?
| Status: | Recruiting |
|---|---|
| Conditions: | Ocular |
| Therapuetic Areas: | Ophthalmology |
| Healthy: | No |
| Age Range: | 18 - Any |
| Updated: | 4/21/2016 |
| Start Date: | January 2015 |
| End Date: | January 2016 |
| Contact: | Henry D Jampel, MD |
| Email: | hjampel@jhmi.edu |
| Phone: | 410-614-2339 |
- 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.
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.
- 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.
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.
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
We found this trial at
1
site
Click here to add this to my saved trials
