Does Oral Acetaminophen Lower Intraocular Pressure?

NCT02366065 | Completed Early Phase 1

• 1 other identifier: CIR00006973
• Study Type: interventional
• Target: 11
• Locations: 1 country
• Sites: 1

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.

Conditions

Glaucoma

Outcome Measures

Primary Outcomes (1)

• Lowering Eye Pressure

  Eye pressure will be measured by using an IOP applanation tonometer seven days after the patient has stopped the medication.

  7 days

Study Arms (1)

Acetaminophen

EXPERIMENTAL

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.

Drug: Acetaminophen

Interventions

Acetaminophen DRUG

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.

Also known as: tylenol

Acetaminophen

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• using acetaminophen
• history of hepatic disease either reported by the patient or documented in the patient's medical record

Sponsors & Collaborators

• Johns Hopkins University: lead

Study Sites (1)

Johns Hopkins - The Wilmer Eye Institute

Baltimore, Maryland, 21009, United States

Location

Related Publications (1)

• 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.

  PMID: 23390358 BACKGROUND

MeSH Terms

Conditions

Glaucoma

Interventions

Acetaminophen

Condition Hierarchy (Ancestors)

Ocular Hypertension; Eye Diseases

Intervention Hierarchy (Ancestors)

Acetanilides; Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines

Study Officials

• Henry D Jampel, MD

  Johns Hopkins University - Wilmer Eye Institute

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: January 28, 2015
• First Posted: February 19, 2015
• Study Start: January 1, 2015
• Primary Completion: May 1, 2016
• Study Completion: May 1, 2016
• Last Updated: June 7, 2016

Record last verified: 2016-06

Locations

US (1)