Does Oral Acetaminophen Lower Intraocular Pressure?
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| ClinicalTrials.gov Identifier: NCT02366065 |
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Recruitment Status :
Completed
First Posted : February 19, 2015
Last Update Posted : June 7, 2016
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| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Glaucoma | Drug: Acetaminophen | Early Phase 1 |
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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 : | Interventional (Clinical Trial) |
| Actual Enrollment : | 11 participants |
| Intervention Model: | Single Group Assignment |
| Masking: | None (Open Label) |
| Primary Purpose: | Treatment |
| Official Title: | Does Oral Acetaminophen Lower Intraocular Pressure? |
| Study Start Date : | January 2015 |
| Actual Primary Completion Date : | May 2016 |
| Actual Study Completion Date : | May 2016 |
| Arm | Intervention/treatment |
|---|---|
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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.
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Drug: Acetaminophen
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 Name: tylenol |
- 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.
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| Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
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
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02366065
| United States, Maryland | |
| Johns Hopkins - The Wilmer Eye Institute | |
| Baltimore, Maryland, United States, 21009 | |
| Principal Investigator: | Henry D Jampel, MD | Johns Hopkins University - Wilmer Eye Institute |
Publications:
| Responsible Party: | Henry D. Jampel, M.D., M.H.S., Professor, Johns Hopkins University |
| ClinicalTrials.gov Identifier: | NCT02366065 History of Changes |
| Other Study ID Numbers: |
CIR00006973 |
| First Posted: | February 19, 2015 Key Record Dates |
| Last Update Posted: | June 7, 2016 |
| Last Verified: | June 2016 |
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Glaucoma Ocular Hypertension Eye Diseases Acetaminophen Analgesics, Non-Narcotic |
Analgesics Sensory System Agents Peripheral Nervous System Agents Physiological Effects of Drugs Antipyretics |