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The Effects of Caffeinated Coffee on Intraocular Pressure

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ClinicalTrials.gov Identifier: NCT01364207
Recruitment Status : Completed
First Posted : June 2, 2011
Results First Posted : October 31, 2012
Last Update Posted : October 31, 2012
Sponsor:
Information provided by (Responsible Party):
Massachusetts Eye and Ear Infirmary

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Crossover Assignment;   Masking: Double (Participant, Investigator)
Condition Primary Open Angle Glaucoma
Interventions Other: Caffeinated Coffee
Other: Decaffeinated Coffee
Enrollment 112
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Caffeinated Coffee 1st Visit, Decaffeinated Coffee 2nd Visit Decaffeinated Coffee 1st Visit, Caffeinated Coffee 2nd Visit
Hide Arm/Group Description 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. 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.
Period Title: First Visit (~1.5-2 Hours)
Started 54 58
Completed 54 58
Not Completed 0 0
Period Title: Time Between Visits (2 Days to 4 Weeks)
Started 54 58
Completed 52 54
Not Completed 2 4
Period Title: Second Visit (~1.5-2 Hours)
Started 52 54
Completed 52 54
Not Completed 0 0
Arm/Group Title All Participants Who Completed Both Study Visits
Hide Arm/Group Description 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.
Overall Number of Baseline Participants 106
Hide Baseline Analysis Population Description
[Not Specified]
Age Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 106 participants
64.4  (11.7)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 106 participants
Female
54
  50.9%
Male
52
  49.1%
Baseline Intraocular Pressure on Caffeinated Coffee Visit   [1] 
Mean (Standard Deviation)
Unit of measure:  mmHg
Number Analyzed 106 participants
15.90  (2.78)
[1]
Measure Description: The intraocular pressure measured at baseline prior to ingestion of caffeinated coffee on the caffeinated coffee visit.
Baseline Intraocular Pressure on Decaffeinated Coffee Visit   [1] 
Mean (Standard Deviation)
Unit of measure:  mmHg
Number Analyzed 106 participants
16.01  (2.72)
[1]
Measure Description: The intraocular pressure measured at baseline prior to ingestion of decaffeinated coffee on the decaffeinated coffee visit.
1.Primary Outcome
Title Change in Intraocular Pressure at 60 Minutes
Hide Description

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

Time Frame Prior to coffee ingestion (baseline), 60 minutes post coffee ingestion
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Caffeinated Coffee Decaffeinated Coffee
Hide Arm/Group Description:
Participants drank an 8 oz cup of caffeinated coffee.
Participants drank an 8 oz cup of decaffeinated coffee.
Overall Number of Participants Analyzed 106 106
Mean (Standard Deviation)
Unit of Measure: mm Hg
1.51  (1.54) 0.52  (1.29)
2.Primary Outcome
Title Change in Intraocular Pressure at 90 Minutes
Hide Description

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

Time Frame Prior to coffee ingestion (baseline), 90 minutes post coffee ingestion
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Caffeinated Coffee Decaffeinated Coffee
Hide Arm/Group Description:
Participants drank an 8 oz cup of caffeinated coffee.
Participants drank an 8 oz cup of decaffeinated coffee.
Overall Number of Participants Analyzed 106 106
Mean (Standard Deviation)
Unit of Measure: mm Hg
1.46  (1.68) 0.40  (1.37)
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Caffeinated Coffee Decaffeinated Coffee
Hide Arm/Group Description Participants drank an 8 oz cup of caffeinated coffee. Participants drank an 8 oz cup of decaffeinated coffee.
All-Cause Mortality
Caffeinated Coffee Decaffeinated Coffee
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Caffeinated Coffee Decaffeinated Coffee
Affected / at Risk (%) Affected / at Risk (%)
Total   0/108 (0.00%)   0/110 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 1%
Caffeinated Coffee Decaffeinated Coffee
Affected / at Risk (%) Affected / at Risk (%)
Total   0/108 (0.00%)   0/110 (0.00%) 
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.
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Name/Title: Dr. Louis R. Pasquale
Organization: Massachusetts Eye and Ear Infirmary
Phone: 617-573-4240 ext 4240
Responsible Party: Massachusetts Eye and Ear Infirmary
ClinicalTrials.gov Identifier: NCT01364207     History of Changes
Other Study ID Numbers: 09-06-052
First Submitted: November 5, 2010
First Posted: June 2, 2011
Results First Submitted: June 8, 2012
Results First Posted: October 31, 2012
Last Update Posted: October 31, 2012