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The Effects of Caffeinated Coffee on Intraocular Pressure

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Massachusetts Eye and Ear Infirmary
ClinicalTrials.gov Identifier:
NCT01364207
First received: November 5, 2010
Last updated: October 1, 2012
Last verified: October 2012
History of Changes
Results First Received: June 8, 2012  
Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Crossover Assignment;   Masking: Double Blind (Subject, Investigator)
Condition: Primary Open Angle Glaucoma
Interventions: Other: Caffeinated Coffee
Other: Decaffeinated Coffee

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
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Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
Caffeinated Coffee 1st Visit, Decaffeinated Coffee 2nd Visit Participants drank an 8 oz cup of caffeinated coffee on the their first visit, and then an 8 oz cup of decaffeinated coffee on their second visit. The second visit was completed 2 days to 4 weeks after the first visit, depending on the participants' schedules. Participants did not ingest caffeine in any form starting from 12:01am the day of the visit until after the visit that day except for the study coffee we gave to them.
Decaffeinated Coffee 1st Visit, Caffeinated Coffee 2nd Visit Participants drank an 8 oz cup of decaffeinated coffee on the their first visit, and then an 8 oz cup of caffeinated coffee on their second visit. The second visit was completed 2 days to 4 weeks after the first visit, depending on the participants' schedules. Participants did not ingest caffeine in any form starting from 12:01am the day of the visit until after the visit that day except for the study coffee we gave to them.

Participant Flow for 3 periods

 Period 1:   First Visit (~1.5-2 Hours)
    Caffeinated Coffee 1st Visit, Decaffeinated Coffee 2nd Visit     Decaffeinated Coffee 1st Visit, Caffeinated Coffee 2nd Visit  
STARTED     54     58  
COMPLETED     54     58  
NOT COMPLETED     0     0  

Period 2:   Time Between Visits (2 Days to 4 Weeks)
    Caffeinated Coffee 1st Visit, Decaffeinated Coffee 2nd Visit     Decaffeinated Coffee 1st Visit, Caffeinated Coffee 2nd Visit  
STARTED     54     58  
COMPLETED     52     54  
NOT COMPLETED     2     4  

Period 3:   Second Visit (~1.5-2 Hours)
    Caffeinated Coffee 1st Visit, Decaffeinated Coffee 2nd Visit     Decaffeinated Coffee 1st Visit, Caffeinated Coffee 2nd Visit  
STARTED     52     54  
COMPLETED     52     54  
NOT COMPLETED     0     0  



  Baseline Characteristics
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Reporting Groups
  Description
All Participants Who Completed Both Study Visits 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.

Baseline Measures
    All Participants Who Completed Both Study Visits  
Number of Participants  
[units: participants]
 		  106  
Age  
[units: years]
Mean ± Standard Deviation 		  64.4  ± 11.7  
Gender  
[units: participants]
 		 
Female     54  
Male     52  
Baseline Intraocular Pressure on Caffeinated Coffee Visit [1]
[units: mmHg]
Mean ± Standard Deviation 		  15.90  ± 2.78  
Baseline Intraocular Pressure on Decaffeinated Coffee Visit [2]
[units: mmHg]
Mean ± Standard Deviation 		  16.01  ± 2.72  
[1] The intraocular pressure measured at baseline prior to ingestion of caffeinated coffee on the caffeinated coffee visit.
[2] The intraocular pressure measured at baseline prior to ingestion of decaffeinated coffee on the decaffeinated coffee visit.



  Outcome Measures
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1.  Primary:   Change in Intraocular Pressure at 60 Minutes   [ Time Frame: Prior to coffee ingestion (baseline), 60 minutes post coffee ingestion ]
  Show Outcome Measure 1

2.  Primary:   Change in Intraocular Pressure at 90 Minutes   [ Time Frame: Prior to coffee ingestion (baseline), 90 minutes post coffee ingestion ]
  Show Outcome Measure 2


  Serious Adverse Events
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  Other Adverse Events
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  More Information
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Certain Agreements:  
All Principal Investigators ARE employed by the organization sponsoring the study.


Limitations and Caveats
Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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.  


Results Point of Contact:  
Name/Title: Dr. Louis R. Pasquale
Organization: Massachusetts Eye and Ear Infirmary
phone: 617-573-4240 ext 4240
e-mail: aliya_jiwani@meei.harvard.edu


No publications provided


Responsible Party: Massachusetts Eye and Ear Infirmary
ClinicalTrials.gov Identifier: NCT01364207     History of Changes
Other Study ID Numbers: 09-06-052
Study First Received: November 5, 2010
Results First Received: June 8, 2012
Last Updated: October 1, 2012
Health Authority: United States: Institutional Review Board