Intraocular PressureNCT01793311
The Effect of Dosage of Caffeine on Intraocular Pressure
A study testing decaffeinated coffee, regular dose coffee and high dose coffee in people with Intraocular Pressure and Caffeine Dosage, run by Chiang Mai University at 1 site in Thailand.
Trial 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. group 1: intake of decaffeinated coffee 2. Read more about this study
- Who is it for?
- Ages 20 to 35 yearsHealthy volunteers can take part
- Conditions the study is for
- Intraocular Pressure, Caffeine Dosage
- What is being tested?
- decaffeinated coffee, regular dose coffee and high dose coffee
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 60 participants
- Where
- 1 siteThailand
- Study dates
- Feb 2013to Mar 2013
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 20 to 35 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- healthy subjects
- normal central corneal thickness
- normal baseline intraocular pressure
Who cannot join
- any ocular disease
- baseline intraocular pressure over 21 mmHg
- central corneal thickness less than 520 microns or more than 540 microns
Trial locations and contacts
1 site in 1 country.
Thailand1 site, 1 recruiting
- Recruiting
Chiang Mai University Hospital
Muang, Chiang Mai, 50200
Damrong Wiwatwongwana, M.D., 6653945512 ext. 5515, samseeha@hotmail.com
Damrong Wiwatwongwana, M.D.
About this study
Official title: The Effect of Dosage of Caffeine on Intraocular Pressure in Healthy Subjects
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:
- group 1: intake of decaffeinated coffee
- group 2: intake of coffee with lower caffeine dose
- group 3: intake of coffee with higher caffeine dose
Intraocular pressure will be measured at 0, 30, 60 and 90 minutes after coffee intake.
Read the detailed description
decaffeinated coffee contains 0.5-2 mg of caffeine regular dose coffee contains 91.8 mg of caffeine high dose coffee contains 144 mg of caffeine
all three groups' intraocular pressure will be measured with the Goldmann applanation tonometer at 4 timepoints:
- 0 minutes (baseline)
- 30 minutes after intake
- 60 minutes after intake
- 90 minutes after intake
- Conditions
- Intraocular Pressure, Caffeine Dosage
- Being tested
- decaffeinated coffee, regular dose coffee, high dose coffee
- Keywords
- intraocular pressure, caffeine, dosage
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
decaffeinated coffeeOther
contains caffeine 0.5-2 mg
regular dose coffeeOther
contains 91.8 mg of caffeine
high dose coffeeOther
contains 144 mg of caffeine
| Study group | Role | What they receive |
|---|---|---|
| Group1: Decaffeinated coffee | Sham comparator | contains 0.5-2 mg of caffeine Receives: Other: decaffeinated coffee |
| Group2: regular dose coffee | Active comparator | contains 91.8 mg of caffeine Receives: Other: regular dose coffee |
| Group3: high dose coffee | Active comparator | contains 144 mg of caffeine Receives: Other: high dose coffee |
What is being measured
The primary outcome is the main question the study is designed to answer.
change from baseline in intraocular pressure (mmHg)after caffeine intake
intraocular pressure measured at 4 timepoints:
- 0 minutes (baseline)
- 30 minutes after intake
- 60 minutes after intake
- 90 minutes after intake
Measured: 0, 30 minutes, 60 minutes, 90 minutes post-caffeine intake
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Feb 2013 (estimated)
- Study startFeb 2013
- Primary completionMar 2013 (estimated)
- Study completionMar 2013 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Intraocular PressureStudies 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
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Chiang Mai University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Damrong Wiwatwongwana, Chiang Mai University
- Investigators
- Damrong Wiwatwongwana, M.D., Principal investigator, Chiang Mai University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01793311
- Sponsor's protocol ID
- OPT-11-03-03A-12-X
- Status last verified
- Feb 2013
- First submitted
- 13 Feb 2013
- Last updated
- 15 Feb 2013
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 15 Feb 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Dosage of Caffeine on Intraocular Pressure in Healthy Subjects
- ClinicalTrials.gov ID
- NCT01793311
- Acronym / sponsor ID
- OPT-11-03-03A-12-X
- Conditions
- Intraocular Pressure, Caffeine Dosage
- Keywords
- intraocular pressure, caffeine, dosage
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Chiang Mai UniversityUniversity, hospital or other
- Study start
- Feb 2013
- Primary completion
- Mar 2013 (estimated)
- Study completion
- Mar 2013 (estimated)
- First posted
- 15 Feb 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- group 1: intake of decaffeinated coffee
- group 2: intake of coffee with lower caffeine dose
- group 3: intake of coffee with higher caffeine dose
Intraocular pressure will be measured at 0, 30, 60 and 90 minutes after coffee intake.
Detailed description
decaffeinated coffee contains 0.5-2 mg of caffeine regular dose coffee contains 91.8 mg of caffeine high dose coffee contains 144 mg of caffeine
all three groups' intraocular pressure will be measured with the Goldmann applanation tonometer at 4 timepoints:
- 0 minutes (baseline)
- 30 minutes after intake
- 60 minutes after intake
- 90 minutes after intake
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Group1: Decaffeinated coffee | Sham comparator | Other: decaffeinated coffeecontains 0.5-2 mg of caffeine |
| Group2: regular dose coffee | Active comparator | Other: regular dose coffeecontains 91.8 mg of caffeine |
| Group3: high dose coffee | Active comparator | Other: high dose coffeecontains 144 mg of caffeine |
Who may qualify
- Ages
- 20 to 35 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- healthy subjects
- normal central corneal thickness
- normal baseline intraocular pressure
Key exclusion criteria (3 listed)
- any ocular disease
- baseline intraocular pressure over 21 mmHg
- central corneal thickness less than 520 microns or more than 540 microns
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 |
|---|---|---|
| decaffeinated coffeecontains caffeine 0.5-2 mg | Other | Group1: Decaffeinated coffee |
| regular dose coffeecontains 91.8 mg of caffeine | Other | Group2: regular dose coffee |
| high dose coffeecontains 144 mg of caffeine | Other | Group3: high dose coffee |
Primary outcome
change from baseline in intraocular pressure (mmHg)after caffeine intake
Time frame: 0, 30 minutes, 60 minutes, 90 minutes post-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
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Feb 2013.
Related trials for Intraocular Pressure
Active, not recruiting
Effect of IOP Lowering on Progressive HM
High Myopia, Intraocular Pressure
Recruiting
Automated Applanation Tonometry - Updated
Glaucoma, Glaucoma, Suspect
RecruitingPhase 2
A Phase 2a Study Comparing the Efficacy, Safety and Tolerability of Pregabalin Eye Drops Comparing With Timolol Eye Drops in Adults With Glaucoma or High Eye Pressure.
Primary Open - Angle Glaucoma (POAG), Ocular Hypertension (OHT)
Not yet recruiting
Glaucoma Drop Aids Part 2
Glaucoma, Intraocular Pressure
Not yet recruitingPhase 4
Iopidine to Decrease Intraocular Pressure Rise After Injections
Macular Degeneration, Diabetic Retinopathy
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.
Damrong Wiwatwongwana, M.D. principal investigator
Chiang Mai University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing decaffeinated coffee, regular dose coffee and high dose coffee in people with Intraocular Pressure and Caffeine Dosage, run by Chiang Mai University at 1 site in Thailand.
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 3 inclusion and 3 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: status not confirmed, as of the sponsor's last update on 15 Feb 2013. 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 Thailand. 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. Some participants in this study may receive a placebo. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Damrong Wiwatwongwana, M.D. (6653945512 ext. 5515, samseeha@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
change from baseline in intraocular pressure (mmHg)after caffeine intake (time frame: 0, 30 minutes, 60 minutes, 90 minutes post-caffeine intake). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 15 Feb 2013.