ORBS Study

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 long prescription of either; a daily 40 mg dose of doxycycline, a 200 mg tdose of doxycycline or a daily placebo.
• You will have 4 eye examinations. You will have cotton swab specimens from your eye and gut taken at the beginning of your participation, at 4 weeks, at 8 weeks and at 3-6 months after your last dose of study medication. The doctor will obtain the cotton swab from the eye by touching it to the skin your lower eyelids. You will be given instruction on how to self swab your rectum for the gut microbiome testing.
• In addition we will take pictures of your eyelids and eyeballs and ask you to fill out dry eye symptom surveys.

Additional details of this study can be found at ClinicalTrials.gov: https://clinicaltrials.gov/ct2/show/NCT05296837?cond=ocular+rosacea&cntr...

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?

• Contact us at [email protected] and we will discuss enrollment.

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 finical 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.

What are the 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?

STUDY TEAM

Gerami Seitzman, MD Principal Investigator

Benjamin Arnold, PhD Biostatistician

Matilda Chan MD PhD Co-investigator

Victoria Cavallino, MSPH Study Coordinator

Thuy Doan, MD, PhD Genetics evaluation

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