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Anti-inflammatory

Low-Dose Doxycycline for Ocular Rosacea (ORBS Trial)

Phase 4
Recruiting
Led By Gerami Seitzman, MD
Research Sponsored by University of California, San Francisco
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 4 weeks , 8 weeks, 3 - 6 months
Awards & highlights
Pivotal Trial
Drug Has Already Been Approved

Summary

This trial is a study to see if a new lower dose of an old antibiotic, doxycycline, is effective in treating ocular rosacea, and if it has fewer side effects than the standard dose.

Who is the study for?
This trial is for adults over 18 with symptomatic ocular rosacea, which affects the eyes and eyelids. Participants must be able to consent and not have used oral antibiotics in the last three months. They can't join if they're allergic to tetracycline antibiotics, currently have an infection, or are pregnant or might become pregnant during the study.
What is being tested?
The study tests two doses of doxycycline (40mg daily as SDD and 200mg daily) against a placebo to see how well they control severe ocular rosacea symptoms like eye redness and corneal issues without causing antimicrobial resistance.
What are the potential side effects?
Doxycycline may cause side effects such as digestive upset, skin sensitivity to sunlight, teeth discoloration, headache, or visual disturbances. The lower dose aims to reduce inflammation with fewer risks of altering bacteria resistance.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~4 weeks , 8 weeks, 3 - 6 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and 4 weeks , 8 weeks, 3 - 6 months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Frequency of Antimicrobial Resistance (AMR) genetic determinants
Secondary study objectives
Differences in Simpson's diversity of the microbiome of the conjunctiva and gut
Ocular Surface Disease Index (OSDI) will be compared
Tear Breakup Time (TBUT) scores will be compared

Awards & Highlights

Pivotal Trial
The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
Drug Has Already Been Approved
The FDA has already approved this drug, and is just seeking more data.

Trial Design

3Treatment groups
Experimental Treatment
Active Control
Placebo Group
Group I: 40mg of oral doxycyclineExperimental Treatment1 Intervention
Arm A will receive submicrobial dose doxycycline (40mg) administered as 20mg twice a day for 8 weeks
Group II: 100mg of oral doxycyclineActive Control1 Intervention
Arm B will receive 200mg of oral doxycycline administered as 100mg twice a day for 8 weeks
Group III: PlaceboPlacebo Group1 Intervention
Arm C will receive a placebo twice a day for 8 weeks

Find a Location

Who is running the clinical trial?

University of California, San FranciscoLead Sponsor
2,587 Previous Clinical Trials
14,901,126 Total Patients Enrolled
1 Trials studying Antimicrobial Resistance
3,300,000 Patients Enrolled for Antimicrobial Resistance
Gerami Seitzman, MDPrincipal InvestigatorUniversity of California, San Francisco

Media Library

Doxycycline 100 MG Oral Tablet (Anti-inflammatory) Clinical Trial Eligibility Overview. Trial Name: NCT05296837 — Phase 4
Antimicrobial Resistance Research Study Groups: 40mg of oral doxycycline, Placebo, 100mg of oral doxycycline
Antimicrobial Resistance Clinical Trial 2023: Doxycycline 100 MG Oral Tablet Highlights & Side Effects. Trial Name: NCT05296837 — Phase 4
Doxycycline 100 MG Oral Tablet (Anti-inflammatory) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05296837 — Phase 4
~20 spots leftby Oct 2025
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