80 Participants Needed

Caffeine Consumption for Glaucoma

MR
JM
Overseen ByJeanne Molineaux, COA
Age: 18+
Sex: Any
Trial Phase: Academic
Sponsor: Wills Eye
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)
Approved in 3 JurisdictionsThis treatment is already approved in other countries

Trial Summary

What is the purpose of this trial?

Caffeine is the most widely consumed drinking nutrient in the world. Caffeine effects various organs and the vascular system. It decreases ocular blood flow due to vasoconstriction.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

Is caffeine safe for human consumption?

Research shows that caffeine, when combined with other medications like paracetamol or ibuprofen, is generally safe for treating tension-type headaches, with no significant difference in safety compared to other treatments like naproxen or placebo.12345

How does caffeine consumption differ from other treatments for glaucoma?

Caffeine is unique in its potential use for glaucoma as it is not a standard treatment for this condition. Unlike typical glaucoma medications that reduce eye pressure, caffeine's role as an adjuvant (helper) in pain relief is due to its action on adenosine receptors, which is different from the mechanisms of traditional glaucoma drugs.56789

Research Team

MR

M. Reza Razeghinejad, MD

Principal Investigator

Wills Eye Hospital

Eligibility Criteria

This trial is for adults aged 18-90 with primary open-angle glaucoma, as well as healthy individuals without eye diseases. It's not suitable for those with conditions affecting eye test results, severe cataracts, nystagmus, macular degeneration (except mild), diabetic retinopathy, certain optic neuropathies or corneal issues, rheumatologic diseases like Raynaud's phenomenon, pregnant or breastfeeding women, mental illness or alcohol addiction.

Inclusion Criteria

I am between 18 and 90 years old.
I have been diagnosed with primary open angle glaucoma.
I have healthy eyes with no eye diseases.

Exclusion Criteria

I cannot focus my eyes on a specific point.
Mental illness or alcohol addiction
Possible tolerance to caffeine (drinking more than 1 cup coffee per day)
See 12 more

Timeline

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

Baseline Assessment

Participants complete baseline study tasks before caffeine ingestion

1 day
1 visit (in-person)

Caffeine Ingestion and Monitoring

Participants ingest a 200 mg caffeine tablet and undergo OCTA scans 1 and 2 hours post-ingestion

1 day
1 visit (in-person)

Follow-up

Participants are monitored for any delayed effects of caffeine on ocular blood flow

1 week

Treatment Details

Interventions

  • Caffeine
Trial OverviewThe study is looking at the effects of a caffeine tablet on people with glaucoma compared to healthy subjects. The focus is on how caffeine influences ocular blood flow and potentially affects the vascular system within the eyes.
Participant Groups
2Treatment groups
Active Control
Group I: Glaucoma PatientsActive Control1 Intervention
Eligible participants include patients with mild, moderate or advanced primary open angle glaucoma (POAG) or primary angle closure glaucoma (PACG). Each participant will complete baseline study tasks. Each participant will then receive one 200 mg caffeine tablet to ingest. Study tasks will be performed 1 hour and 2 hours after caffeine ingestion.
Group II: Healthy controlsActive Control1 Intervention
Eligible participants include healthy subjects with no eye diseases. Each participant will complete baseline study tasks. Each participant will then receive one 200 mg caffeine tablet to ingest. Study tasks will be performed 1 hour and 2 hours after caffeine ingestion.

Find a Clinic Near You

Who Is Running the Clinical Trial?

Wills Eye

Lead Sponsor

Trials
81
Recruited
15,400+

Findings from Research

The 22nd French pharmacovigilance meeting revealed 315 notifications of severe adverse effects linked to non-specific 'immunostimulants', with 68% of cases considered likely attributable to the drugs, including three fatalities.
The meeting highlighted that many adverse effects, both known and rare, continue to occur with various medications, emphasizing the need for better documentation and monitoring of drug safety, as well as the potential for immediate market withdrawal of drugs with poor risk-benefit ratios.
Highlights of the 22nd French pharmacovigilance meeting.[2007]
Sofosbuvir has a significant interaction with amiodarone, leading to a risk of severe bradycardia, highlighting the need for caution when these drugs are used together.
SGLT2 inhibitors are associated with risks of diabetic ketoacidosis and bone fractures, indicating important safety considerations for patients using these medications.
[Pharmacovigilance update].Dao, K., Chtioui, H., Rothuizen, LE., et al.[2016]
A multicenter, double-blind, placebo-controlled trial was conducted to evaluate the effectiveness and safety of combining ibuprofen with caffeine for treating tension-type headaches, building on previous evidence of caffeine's analgesic properties.
The study aims to confirm the pain-relieving effects of caffeine and explore how tension-type headaches can serve as a useful model for pain research.
The use of ibuprofen plus caffeine to treat tension-type headache.Diamond, S., Freitag, FG.[2019]

References

Highlights of the 22nd French pharmacovigilance meeting. [2007]
[Pharmacovigilance update]. [2016]
The use of ibuprofen plus caffeine to treat tension-type headache. [2019]
Toxicological effect of Artemisinin-Based Combination Therapies plus Paracetamol in malaria patients. [2023]
Tolerability and efficacy of a combination of paracetamol and caffeine in the treatment of tension-type headache: a randomised, double-blind, double-dummy, cross-over study versus placebo and naproxen sodium. [2018]
Efficacy of dosing and re-dosing of two oral fixed combinations of indomethacin, prochlorperazine and caffeine compared with oral sumatriptan in the acute treatment of multiple migraine attacks: a double-blind, double-dummy, randomised, parallel group, multicentre study. [2018]
[Caffeine in analgesics--myth or medicine?]. [2019]
Efficacy and tolerability of combined dipyrone, isometheptene and caffeine in the treatment of mild-to-moderate primary headache episodes. [2015]
Efficacy of a fixed combination of indomethacin, prochlorperazine, and caffeine in the treatment of episodic tension-type headache: a double-blind, randomized, nimesulide-controlled, parallel group, multicentre trial. [2015]