ORBS

ORBs-Ocular Rosacea microBiome Study

Ocular rosacea is a long-term condition that causes inflammation of the eyes and eyelids. It can lead to a variety of eye problems—from mild redness and irritation to more serious issues like corneal damage, which can affect vision.

Mild cases of ocular rosacea can often be managed with eye drops and ointments. For more serious or stubborn cases, doctors commonly prescribe an oral medication called doxycycline. This drug can be given at different doses. High doses (like 200 mg/day) are used to treat infections, while lower doses (like 40 mg/day) are thought to reduce inflammation without killing bacteria—these are called sub-microbial doses (SDD).

Why are we conducting this study?

Currently, there is no consensus on the standard of care dosage of doxycycline for the treatment of rosacea or for the treatment of ocular rosacea. Little data exists about the overall effectiveness and appropriate length of treatment of sub-microbial dose doxycycline (SDD) for ocular rosacea.

Our team at the Proctor Foundation at UCSF is conducting this study to evaluate the classification of 40 mg of doxycycline as an SDD by conducting a randomized clinical trial.

We will compare the effects of 40 mg of doxycycline, 200 mg doxycycline, and a placebo pill (which will have no effect) on the microbiome of the conjunctiva and gut. We will also evaluate resistance rates.

The doses of doxycycline used in this study are both frequently used doses for the treatment of both rosacea and ocular rosacea. Doxycycline is generally well tolerated with the most common side effects being an upset stomach or abdominal discomfort, and increased susceptibility to a sunburn.

What is involved in participating in this study?

If you agree to participate in this study:

  • You will be randomized to a study group and given an 8-week prescription of either a daily 40 mg dose of doxycycline, a 200 mg dose of doxycycline, or a daily placebo.
  • You will have 4 eye examinations. Cotton swab specimens from your eye and gut will be collected at baseline, 4 weeks, 8 weeks, and 3–6 months after your last dose. The doctor will collect the eye swab by touching it to the skin of your lower eyelids. You will be given instructions on how to self-swab your rectum for gut microbiome testing.
  • In addition, we will take pictures of your eyelids and eyes and ask you to complete dry eye symptom surveys.

Additional details of this study can be found at [ClinicalTrials.gov]

or visit: https://clinicaltrials.gov/ct2/show/NCT05296837?cond=ocular+rosacea&cntry=US&draw=2&rank=1

What is a microbiome?

A microbiome is the collection of genetic material that is made from all the micro-organisms that normally live in and on all parts of our body.

 

FAQs

Do I have to pay for the medication?

  • No, all study medication will be provided to you free of cost.

What if I want to stop being a participant in the study?

  • You may end your participation at any time by informing a member of the study staff.

When will I figure out what dose I took?

  • When the entire study has been completed, we will let you know which group you belonged to.
How to enroll?

This study is no longer enrolling.

What is Doxycycline?

Doxycycline is an antibiotic used to treat many bacterial infections, prevent malaria, and treat rosacea. It is in a class of medications called tetracycline antibiotics.

What are the common side effects from doxycycline?
  • The most common side effects with this kind of antibiotic are diarrhea, abdominal pain, nausea, or rash.
  • Specific to doxycycline, there is a risk of increased sun sensitivity, and sun protection is recommended.
  • Each participant will be asked about any adverse symptoms experienced during follow-up.
Will I be paid any financial compensation for participating?

No, you will not be offered financial compensation. There is no charge to participate in the trial, and you will be provided the medication and materials free of cost.

Study sites?

The University of California, San Francisco is the site of this study.

How many participants will be enrolled in this study?

We hope to enroll 50 patients in this trial.

How do I contact study staff?

Please email [email protected] or call 415-476-1442, leave a message indicating you would like to speak to an ORBS team member.

Study stuff

Gerami Seitzman, MD Principal Investigator 

Benjamin Arnold, PhD Biostatistician 

Matilda Chan MD PhD Co-investigator 

Thuy Doan, MD, PhD Laboratory Lead

John Gonzales MD Co-investigator 

Jeremy Keenan MD MPH Co-investigator and data analyst

Thomas Lietman MD Data analysis 

Sarah Lopez, OD Study Team Lead 

 Shreya Malli, OD Study Team Lead 

Julie Schallhorn MD Co-investigator 

 

 

Brianna Colado Study Coordinator