NCT01793311

Brief Summary

The goal of the study is to determine the effect of different doses of caffeine on intraocular pressure. We hypothesized that higher dosage of caffeine would increase intraocular pressure more than lower doses. Eligible subjects will be randomized into three groups:

  1. 1.group 1: intake of decaffeinated coffee
  2. 2.group 2: intake of coffee with lower caffeine dose
  3. 3.group 3: intake of coffee with higher caffeine dose

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Feb 2013

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2013

Completed
12 days until next milestone

First Submitted

Initial submission to the registry

February 13, 2013

Completed
2 days until next milestone

First Posted

Study publicly available on registry

February 15, 2013

Completed
14 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2013

Completed
Last Updated

February 15, 2013

Status Verified

February 1, 2013

Enrollment Period

28 days

First QC Date

February 13, 2013

Last Update Submit

February 14, 2013

Conditions

Intraocular PressureCaffeine Dosage

Keywords

intraocular pressurecaffeinedosage

Outcome Measures

Primary Outcomes (1)

  • change from baseline in intraocular pressure (mmHg)after caffeine intake

    intraocular pressure measured at 4 timepoints: 1. 0 minutes (baseline) 2. 30 minutes after intake 3. 60 minutes after intake 4. 90 minutes after intake

    0, 30 minutes, 60 minutes, 90 minutes post-caffeine intake

Study Arms (3)

Group1: Decaffeinated coffee

SHAM COMPARATOR

contains 0.5-2 mg of caffeine

Other: decaffeinated coffee

Group2: regular dose coffee

ACTIVE COMPARATOR

contains 91.8 mg of caffeine

Other: regular dose coffee

Group3: high dose coffee

ACTIVE COMPARATOR

contains 144 mg of caffeine

Other: high dose coffee

Interventions

decaffeinated coffeeOTHER

contains caffeine 0.5-2 mg

Group1: Decaffeinated coffee
regular dose coffeeOTHER

contains 91.8 mg of caffeine

Group2: regular dose coffee
high dose coffeeOTHER

contains 144 mg of caffeine

Group3: high dose coffee

Eligibility Criteria

Age20 Years - 35 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • healthy subjects
  • normal central corneal thickness
  • normal baseline intraocular pressure

You may not qualify if:

  • any ocular disease
  • baseline intraocular pressure over 21 mmHg
  • central corneal thickness less than 520 microns or more than 540 microns

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Chiang Mai University Hospital

Muang, Chiang Mai, 50200, Thailand

RECRUITING

MeSH Terms

Interventions

Coffee

Intervention Hierarchy (Ancestors)

Plant PreparationsBiological ProductsComplex MixturesBeveragesDiet, Food, and NutritionPhysiological PhenomenaFood and Beverages

Study Officials

  • Damrong Wiwatwongwana, M.D.

    Chiang Mai University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Damrong Wiwatwongwana, M.D.

CONTACT

6653945512samseeha@hotmail.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
DIAGNOSTIC
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
M.D.

Study Record Dates

First Submitted

February 13, 2013

First Posted

February 15, 2013

Study Start

February 1, 2013

Primary Completion

March 1, 2013

Study Completion

March 1, 2013

Last Updated

February 15, 2013

Record last verified: 2013-02

Locations

TH(1)