Ocular Rosacea Biome Study (ORBS)

February 23, 2024 updated by: University of California, San Francisco

ORBS: Ocular Rosacea Biome Study

Ocular rosacea is an inflammatory disease of the eyelids and ocular surface. Like the facial disease, the ocular condition is chronic and recurrent. Sequelae of ocular rosacea vary from mild to severe. Ocular rosacea may cause chronic eye redness, blepharitis, recurrent chalazia, dry eye, corneal erosion, corneal vascularization, and corneal ulceration. Rosacea affecting the cornea can result in vision loss.

Prescription eye drops and ointments can be used topically to control mild ocular rosacea. However, severe disease, or rosacea that is not well controlled with local treatments is treated systemically. The most commonly used systemic treatment for rosacea is the bacteriostatic antibiotic doxycycline. Rosacea treatment doses of doxycycline vary widely. Treatment-dose doxycycline for systemic infections is 100mg twice a day. However, as rosacea is considered an inflammatory disease, doxycycline is often dosed at what is termed, sub-microbial dose doxycycline (SDD). Initially introduced in the oral medicine literature, SDD are doses 40mg and lower because systemic administration at this dose does not appear to alter the oral mucosa flora or increase resistance rates when given long-term for periodontal disease. Whereas 100mg doxycycline, even when given short term, may increase the percentage of culturable nasopharyngeal flora that is resistant to doxycycline. The FDA does not categorize SDD an antibiotic, stating this dosing is expected to exhibit only anti-inflammatory activity.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

Even though SDD is widely used for the treatment of rosacea, very little confirmatory data exists, to indicate if this dose alters any other systemic mucosa flora or increases antibiotic resistance rates. The classification of 40mg as "sub-microbial" has never been evaluated in patients diagnosed with ocular rosacea. Additionally, confirmation of a "sub-microbial" dose has not been investigated with more sophisticated genomics and resistance tools such as metagenomic deep sequencing (MDS). The goal of this proposal is to use MDS to determine whether SDD given to patients with ocular rosacea can be truly considered sub-microbial, or if a 40mg dose of doxycycline can in fact alter the microbiome of the conjunctiva and gut and increase resistance rates when prescribed for 8 weeks. The investigators plan to evaluate the effect of SDD on resistance and microbiome alteration through a randomized controlled masked trial.

This is a randomized, controlled, masked trial comparing sub-microbial dose doxycycline, treatment dose Doxycycline, and placebo in the treatment of ocular rosacea.

Participants will be recruited from the F.I. Proctor Foundation and the Ophthalmology clinics at the UCSF Wayne and Gladys Valley Center for Vision and consented for participation in an IRB-approved study protocol. Participants with a diagnosis of ocular rosacea (n=50) will be prospectively enrolled and randomized to one of three arms in a 2:2:1 fashion:

Arm A will receive submicrobial dose doxycycline (40mg) administered as 20mg twice day for 8 weeks Arm B will receive 200mg of oral doxycycline administered as 100mg twice a day for 8 weeks Arm C will receive a placebo twice a day for 8 weeks

Study Type

Interventional

Enrollment (Estimated)

50

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Have symptomatic ocular disease attributed to ocular rosacea as the primary diagnosis
  • Ability to give informed consent
  • Be aged 18 years old or older

Exclusion Criteria:

  • Have an active ocular or systemic infection
  • Have a known allergy or intolerance to tetracycline antibiotics
  • Have had prior use of oral antibiotics within the last three months
  • Pregnancy or the possibility of becoming pregnant within the 8-week study medication timeline.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 40mg of oral doxycycline
Arm A will receive submicrobial dose doxycycline (40mg) administered as 20mg twice a day for 8 weeks
Drug: Doxycycline 40 MG ( 20mg twice daily)
Submicrobial dose doxycycline (40mg) to be administered as 20mg twice daily
Active Comparator: 100mg of oral doxycycline
Arm B will receive 200mg of oral doxycycline administered as 100mg twice a day for 8 weeks
Drug: Doxycycline 200 MG ( 100 mg twice daily)
200 mg dose doxycycline to be administered as 100mg twice daily
Placebo Comparator: Placebo
Arm C will receive a placebo twice a day for 8 weeks
Drug: Placebo
Placebo to be administered in tablet form twice daily

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Frequency of Antimicrobial Resistance (AMR) genetic determinants
Time Frame: 8 weeks
The frequency of AMR genetic determinants in rectal swab samples between arms will be compared, correcting for baseline
8 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Differences in Simpson's diversity of the microbiome of the conjunctiva and gut
Time Frame: 4 weeks , 8 weeks, 3 - 6 months
Simpson's diversity is the probability that any two randomly chosen reads will be for different organisms (at the genus level). This will be expressed in terms of effective number.
4 weeks , 8 weeks, 3 - 6 months
Ocular Surface Disease Index (OSDI) will be compared
Time Frame: 4 weeks , 8 weeks, 3 - 6 months

Scores range from 0 to 100, with higher scores indicating greater symptom severity.

Standard 12-question created by the Outcomes Research Group at Allergan Inc will be used.
4 weeks , 8 weeks, 3 - 6 months
Tear Breakup Time (TBUT) scores will be compared
Time Frame: 4 weeks , 8 weeks, 3 - 6 months

Numbers representing how many seconds after a full blink a discontinuity in the tear film appears.

Obtained with the Oculus keratography topographer

This is a scale typically measured from 1-10, and the seconds correspond to the amount of time it takes for a tear film discontinuity to be observed. The lower the number the faster the tear break up and the worse the objective dry eye.
4 weeks , 8 weeks, 3 - 6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of California, San Francisco

Investigators

  • Principal Investigator: Gerami Seitzman, MD, University of California, San Francisco

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 22, 2023

Primary Completion (Estimated)

October 30, 2025

Study Completion (Estimated)

December 31, 2025

Study Registration Dates

First Submitted

March 16, 2022

First Submitted That Met QC Criteria

March 16, 2022

First Posted (Actual)

March 25, 2022

Study Record Updates

Last Update Posted (Estimated)

February 26, 2024

Last Update Submitted That Met QC Criteria

February 23, 2024

Last Verified

February 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 21-34725

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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