← Back to Search

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

ORBS Trial 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.Check my eligibility

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.See study design

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.

ORBS Trial Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 4 weeks , 8 weeks, 3 - 6 months

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Frequency of Antimicrobial Resistance (AMR) genetic determinants

Secondary outcome measures

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

ORBS 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

Do I qualify?Apply below to find out

Find a Location

Who is running the clinical trial?

University of California, San FranciscoLead Sponsor

2,510 Previous Clinical Trials

15,243,657 Total Patients Enrolled

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

Ocular Rosacea Research Study Groups: 40mg of oral doxycycline, Placebo, 100mg of oral doxycycline

Ocular Rosacea 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

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is recruitment underway for this clinical trial?

"According to clinicaltrials.gov, this medical trial has ceased recruitment since the last update on November 28th of 2022. Despite that, 16 other trials are still actively searching for participants."

Answered by AI

What is the risk profile of Doxycycline 40 MG ( 20mg twice daily) for individuals?

"Our team at Power gauged the safety of Doxycycline 40 MG ( 20mg twice daily) to be a 3, as it is currently approved for medical use and has been trialled in Phase 4."

Answered by AI