Trial Outcomes & Findings for The Effects of Caffeinated Coffee on Intraocular Pressure (NCT NCT01364207)

NCT ID: NCT01364207

Last Updated: 2012-10-31

Results Overview

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

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 112 participants
• Primary outcome timeframe: Prior to coffee ingestion (baseline), 60 minutes post coffee ingestion
• Results posted on: 2012-10-31

Participant Flow

Participant milestones

Measure	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.
First Visit (~1.5-2 Hours) STARTED	54	58
First Visit (~1.5-2 Hours) COMPLETED	54	58
First Visit (~1.5-2 Hours) NOT COMPLETED	0	0
Time Between Visits (2 Days to 4 Weeks) STARTED	54	58
Time Between Visits (2 Days to 4 Weeks) COMPLETED	52	54
Time Between Visits (2 Days to 4 Weeks) NOT COMPLETED	2	4
Second Visit (~1.5-2 Hours) STARTED	52	54
Second Visit (~1.5-2 Hours) COMPLETED	52	54
Second Visit (~1.5-2 Hours) NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

The Effects of Caffeinated Coffee on Intraocular Pressure

Baseline characteristics by cohort

Measure	All Participants Who Completed Both Study Visits n=106 Participants 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.
Age Continuous	64.4 years STANDARD_DEVIATION 11.7 • n=5 Participants
Sex: Female, Male Female	54 Participants n=5 Participants
Sex: Female, Male Male	52 Participants n=5 Participants
Baseline Intraocular Pressure on Caffeinated Coffee Visit	15.90 mmHg STANDARD_DEVIATION 2.78 • n=5 Participants
Baseline Intraocular Pressure on Decaffeinated Coffee Visit	16.01 mmHg STANDARD_DEVIATION 2.72 • n=5 Participants

PRIMARY outcome

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

Population: 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.

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

Outcome measures

Measure	Caffeinated Coffee n=106 Participants Participants drank an 8 oz cup of caffeinated coffee.	Decaffeinated Coffee n=106 Participants Participants drank an 8 oz cup of decaffeinated coffee.
Change in Intraocular Pressure at 60 Minutes	1.51 mm Hg Standard Deviation 1.54	0.52 mm Hg Standard Deviation 1.29

PRIMARY outcome

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

Population: 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.

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

Outcome measures

Measure	Caffeinated Coffee n=106 Participants Participants drank an 8 oz cup of caffeinated coffee.	Decaffeinated Coffee n=106 Participants Participants drank an 8 oz cup of decaffeinated coffee.
Change in Intraocular Pressure at 90 Minutes	1.46 mm Hg Standard Deviation 1.68	0.40 mm Hg Standard Deviation 1.37

Adverse Events

Caffeinated Coffee

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Decaffeinated Coffee

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Dr. Louis R. Pasquale

Massachusetts Eye and Ear Infirmary

Phone: 617-573-4240

Email: aliya_jiwani@meei.harvard.edu

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place