Primary Open Angle GlaucomaNCT01364207

The Effects of Caffeinated Coffee on Intraocular Pressure

A study testing Caffeinated Coffee and Decaffeinated Coffee in people with Primary Open Angle Glaucoma, run by Massachusetts Eye and Ear Infirmary at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Who is it for?: Ages 40 to 89 yearsHealthy volunteers can take part
Conditions the study is for: Primary Open Angle Glaucoma
What is being tested?: Caffeinated Coffee and Decaffeinated Coffee
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 112 participants
Where: 1 siteUnited States
Study dates: Nov 2010to Jun 2012
Phase: Interventional
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 40 to 89 years
All sexes
Healthy volunteers accepted
Adult, Older adult

Who may be able to join

40-89 yrs
POAG for cases or no forms of glaucoma for controls
Willingness to drink coffee
Consent signed

Who cannot join

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

Trial locations and contacts

1 site in 1 country.

United States1 site

Massachusetts Eye and Ear Infirmary
Boston, Massachusetts, 02114

Other trials in United States

About this study

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.

Conditions: Primary Open Angle Glaucoma
Being tested: Caffeinated Coffee, Decaffeinated Coffee
Medical subject headings: Glaucoma, Open-Angle

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Caffeinated CoffeeOther
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 CoffeeOther
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.

Study groups in NCT01364207
Study group	Role	What they receive
Caffeinated Coffee 1st Visit, Decaffeinated Coffee 2nd Visit	Experimental	Participants will be given an 8 oz cup of caffeinated coffee on their first visit and 8 oz cup of decaffeinated coffee on their second visit. Receives: Other: Caffeinated Coffee; Other: Decaffeinated Coffee
Decaffeinated Coffee 1st Visit, Caffeinated Coffee 2nd Visit	Experimental	Participants will be given an 8 oz cup of decaffeinated coffee on their first visit and 8 oz cup of caffeinated coffee on their second visit. Receives: Other: Caffeinated Coffee; Other: Decaffeinated Coffee

What is being measured

The primary outcome is the main question the study is designed to answer.

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
Measured: Prior to coffee ingestion (baseline), 60 minutes post coffee ingestion
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
Measured: Prior to coffee ingestion (baseline), 90 minutes post coffee ingestion

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Nov 2010Jun 2012

First posted2 Jun 2011 (estimated)
Study startNov 2010
Primary completionAug 2011
Study completionJun 2012

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for Primary Open Angle GlaucomaStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Allocation: Randomised
Intervention model: Crossover
Masking: Double blind
Who is masked: Participant, Investigator
Enrolment: 112 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01364207
Sponsor's protocol ID: 09-06-052
Status last verified: Oct 2012
First submitted: 5 Nov 2010
Last updated: 31 Oct 2012
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Study at a glance

From the registry record, last updated by the sponsor on 31 Oct 2012. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: The Effects of Caffeinated Coffee on Intraocular Pressure
ClinicalTrials.gov ID: NCT01364207
Acronym / sponsor ID: 09-06-052
Conditions: Primary Open Angle Glaucoma
Study type: Interventional
Recruitment status: Completed
Enrolment: 112 participants (actual)
Lead sponsor: Massachusetts Eye and Ear InfirmaryUniversity, hospital or other
Study start: Nov 2010
Primary completion: Aug 2011 (actual)
Study completion: Jun 2012 (actual)
First posted: 2 Jun 2011 (estimated)
Results: Posted 31 Oct 2012

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Allocation: Randomised
Intervention model: Crossover
Masking: Double blind (participant, investigator)
Number of arms: 2

Arm	Type	Receives
Caffeinated Coffee 1st Visit, Decaffeinated Coffee 2nd Visit	Experimental	Other: Caffeinated Coffee, Other: Decaffeinated CoffeeParticipants will be given an 8 oz cup of caffeinated coffee on their first visit and 8 oz cup of decaffeinated coffee on their second visit.
Decaffeinated Coffee 1st Visit, Caffeinated Coffee 2nd Visit	Experimental	Other: Caffeinated Coffee, Other: Decaffeinated CoffeeParticipants will be given an 8 oz cup of decaffeinated coffee on their first visit and 8 oz cup of caffeinated coffee on their second visit.

Who may qualify

Ages: 40 to 89 years
Sex: All
Healthy volunteers: Accepted
Age groups: Adult, Older adult

Key inclusion criteria (4 listed)

40-89 yrs
POAG for cases or no forms of glaucoma for controls
Willingness to drink coffee
Consent signed

Key exclusion criteria (6 listed)

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

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Caffeinated CoffeeParticipants 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.	Other	Caffeinated Coffee 1st Visit, Decaffeinated Coffee 2nd Visit, Decaffeinated Coffee 1st Visit, Caffeinated Coffee 2nd Visit
Decaffeinated CoffeeParticipants 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.	Other	Caffeinated Coffee 1st Visit, Decaffeinated Coffee 2nd Visit, Decaffeinated Coffee 1st Visit, Caffeinated Coffee 2nd Visit

Primary outcome

Change in Intraocular Pressure at 60 Minutes
Time frame: Prior to coffee ingestion (baseline), 60 minutes post coffee ingestion
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
Change in Intraocular Pressure at 90 Minutes
Time frame: Prior to coffee ingestion (baseline), 90 minutes post coffee ingestion
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

Results and safety

Results posted to the registry on 31 Oct 2012, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Caffeinated Coffee 1st Visit, Decaffeinated Coffee 2nd Visit	54	54
Decaffeinated Coffee 1st Visit, Caffeinated Coffee 2nd Visit	58	58

Primary outcome: Change in Intraocular Pressure at 60 Minutes

Time frame: Prior to coffee ingestion (baseline), 60 minutes post coffee ingestion. Mean (Standard Deviation). Unit: mm Hg

Measure	Caffeinated Coffee n = 106	Decaffeinated Coffee n = 106
Value	1.51 (1.54)	0.52 (1.29)

Population analysed: Only those 106 participants who completed both study visits were included in baseline and final data analyses. The 6 participants who did not complete both study visits were not included in any baseline or final data analyses.

Primary outcome: Change in Intraocular Pressure at 90 Minutes

Time frame: Prior to coffee ingestion (baseline), 90 minutes post coffee ingestion. Mean (Standard Deviation). Unit: mm Hg

Measure	Caffeinated Coffee n = 106	Decaffeinated Coffee n = 106
Value	1.46 (1.68)	0.40 (1.37)

Adverse events

Other adverse events reported at 1% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Caffeinated Coffee	0 of 108 (0%)	0 of 108 (0%)	Not reported
Decaffeinated Coffee	0 of 110 (0%)	0 of 110 (0%)	Not reported

Limitations and caveats (from the sponsor): We gave subjects caffeinated coffee on one visit and decaffeinated coffee on the other visit. The changes in outcome parameters we observed (ie IOP changes) could be due to other non-caffeine components in the coffee.

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 31 Oct 2012.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

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Recruiting
The Acute Effect of Exercise Type And Timing on Ambulatory Blood Pressure and Intra-Ocular Pressure in Individuals With Glaucoma (The ACHIEVE-project).
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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Louis R Pasquale, MD principal investigator

Massachusetts Eye and Ear Infirmary

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing Caffeinated Coffee and Decaffeinated Coffee in people with Primary Open Angle Glaucoma, run by Massachusetts Eye and Ear Infirmary at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 31 Oct 2012. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 31 Oct 2012). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change in Intraocular Pressure at 60 Minutes (time frame: Prior to coffee ingestion (baseline), 60 minutes post coffee ingestion). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01364207.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Oct 2012.