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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01364207
Other study ID # 09-06-052
Secondary ID
Status Completed
Phase N/A
First received November 5, 2010
Last updated October 1, 2012
Start date November 2010
Est. completion date June 2012

Study information

Verified date October 2012
Source Massachusetts Eye and Ear Infirmary
Contact n/a
Is FDA regulated No
Health authority United States: Institutional Review Board
Study type Interventional

Clinical Trial Summary

High intraocular pressure (IOP) is a known risk factor for developing primary open-angle glaucoma (POAG). There is controversy in the literature regarding the degree to which caffeine influences IOP, with some studies reporting minimal changes in IOP while others report up to 4 mmHg increases. To date there are no double-masked randomized controlled trials that examine acute caffeinated coffee's effects on IOP in patients with or at risk for primary open-angle glaucoma. The investigators aim to better understand the relationship between acute caffeinated coffee (vs decaffeinate coffee) consumption and IOP in a double-masked, crossover randomized controlled clinical trial.


Recruitment information / eligibility

Status Completed
Enrollment 112
Est. completion date June 2012
Est. primary completion date August 2011
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Both
Age group 40 Years to 89 Years
Eligibility Inclusion Criteria:

- 40-89 yrs

- POAG for cases or no forms of glaucoma for controls

- Willingness to drink coffee

- Consent signed

Exclusion Criteria:

- Age less than 40 or greater than 89 yrs

- all forms of glaucoma other than POAG

- any condition inappropriate for tonometry (ie corneal disease, LASIK)

- unable or unwilling to give consent

- unable or unwilling to drink coffee

- pregnancy

Study Design

Allocation: Randomized, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Investigator)


Related Conditions & MeSH terms


Intervention

Other:
Caffeinated Coffee
Participants will drink one 8 oz cup in the morning hours. Participants have 15 minutes to drink the coffee but may do so in less time.
Decaffeinated Coffee
Participants will drink one 8 oz cup in the morning hours. Participants have 15 minutes to drink the coffee but may do so in less time.

Locations

Country Name City State
United States Massachusetts Eye and Ear Infirmary Boston Massachusetts

Sponsors (1)

Lead Sponsor Collaborator
Massachusetts Eye and Ear Infirmary

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Change in Intraocular Pressure at 60 Minutes At the caffeinated coffee visit: Change in intraocular pressure at 60 minutes = intraocular pressure at 60 minutes post caffeinated coffee ingestion minus intraocular pressure at baseline prior to caffeinated coffee ingestion
At the decaffeinated coffee visit: Change in intraocular pressure at 60 minutes = intraocular pressure at 60 minutes post decaffeinated coffee ingestion minus intraocular pressure at baseline prior to decaffeinated coffee ingestion
Prior to coffee ingestion (baseline), 60 minutes post coffee ingestion No
Primary Change in Intraocular Pressure at 90 Minutes At the caffeinated coffee visit: Change in intraocular pressure at 90 minutes = intraocular pressure at 90 minutes post caffeinated coffee ingestion minus intraocular pressure at baseline prior to caffeinated coffee ingestion
At the decaffeinated coffee visit: Change in intraocular pressure at 90 minutes = intraocular pressure at 90 minutes post decaffeinated coffee ingestion minus intraocular pressure at baseline prior to decaffeinated coffee ingestion
Prior to coffee ingestion (baseline), 90 minutes post coffee ingestion No
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