Evidence map›Paper›PMID 36539810›Full record

ArticleTrials2022

Ocular Rosacea microBiome Study (ORBS)-sub-microbial versus antibiotic dosing of doxycycline versus placebo in treatment of symptomatic ocular rosacea: study protocol for a parallel-arm randomized clinical trial.

Hamidah Mahmud, Jeremy D Keenan, John Gonzales, Julie Schallhorn, Matilda Chan, Benjamin Arnold, Victoria Cavallino, Thomas M Lietman, Thuy Doan, Gerami D Seitzman

Registry-linked trialOpen access · goldAbstract readClinical Trial Protocol
PubMed Full text at PMC Publisher
In one paragraph

Article in Trials, 2022. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT05296837 (ORBS), which is not on this map. Cited by 2 papers.

0numbers the graph read from it
0cells of the map it votes in
2citing papers in PubMed
0.4field-weighted citation impact, top 32% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

NCT05296837 phase4completednot on this mapstarted 2023, after this paper: background citation

ORBS: Ocular Rosacea Biome Study

TypeinterventionalSponsorUniversity of California, San FranciscoRan2023 to 2025Enrolled46ConditionsOcular Rosacea, Antimicrobial ResistanceArmsDoxycycline 40 MG ( 20mg twice daily), Doxycycline 200 MG ( 100 mg twice daily), Placebo
3 · Its place in the literature

Who cites it

2 citing papers in PubMed, 2 citations in OpenAlex.

  1. Article
  2. Article
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

10 authors at 1 institution in 1 country.

Hamidah MahmudSan Francisco School of Medicine, University of California, San Francisco, CA, USA.
Jeremy D KeenanFrancis I. Proctor Foundation, University of California, San Francisco, CA, USA.
John GonzalesFrancis I. Proctor Foundation, University of California, San Francisco, CA, USA.
Julie SchallhornFrancis I. Proctor Foundation, University of California, San Francisco, CA, USA.
Matilda ChanFrancis I. Proctor Foundation, University of California, San Francisco, CA, USA.
Benjamin ArnoldFrancis I. Proctor Foundation, University of California, San Francisco, CA, USA.
Victoria CavallinoFrancis I. Proctor Foundation, University of California, San Francisco, CA, USA.
Thomas M LietmanFrancis I. Proctor Foundation, University of California, San Francisco, CA, USA.
Thuy DoanFrancis I. Proctor Foundation, University of California, San Francisco, CA, USA.
Gerami D SeitzmanFrancis I. Proctor Foundation, University of California, San Francisco, CA, USA. gerami.seitzman@ucsf.edu.ORCID http://orcid.org/0000-0003-1791-5509
University of California, San Francisco · US

Funding

That Man May See AW212211
6 · The paper itself

Abstract

backgroundOcular rosacea is common and is often managed with long-term antibiotic treatment. Doxycycline is the most commonly selected antibiotic for the treatment of rosacea. As there is no established standard of care treatment dose for rosacea, prescribed doses of doxycycline vary widely. The FDA classifies 40 mg daily dose of doxycycline for ocular rosacea as sub-microbial in comparison to an antibiotic dose of 200 mg daily. However, this "sub-microbial" dose has never been evaluated in patients with ocular rosacea, and even the sub-microbial dose has potential to alter systemic mucosa flora. Here, we present a randomized controlled trial using RNA sequencing to fully characterize the impact of sub-microbial antibiotic dosing of doxycycline on antimicrobial resistance and bacterial composition of the ocular and gut flora.

methodsIn a triple-masked parallel randomized control trial, patients with ocular rosacea will be randomized to three arms: a 40-mg dose of doxycycline, a 200-mg antibiotic dose of doxycycline, or placebo. Collected rectal and lower eyelid samples will be compared for frequency of antimicrobial resistance genetic determinants and microbiome diversity. A subjective ocular surface disease index survey and objective tear breakup time measurement will be determined. DISCUSSION: These results will enhance our understanding of the overall systemic impact of long-term systemic sub-microbial antibiotic dosing for the treatment of chronic recurrent ocular inflammatory diseases.

trial registrationThis trial was registered on ClinicalTrials.org (NCT05296837) on March 22, 2022.

Indexed as

Anti-Infective AgentsGastrointestinal MicrobiomeRosaceaAnti-Bacterial AgentsDoxycyclineHumansRandomized Controlled Trials as TopicAnti-Bacterial AgentsAnti-Infective AgentsDoxycyclineAntimicrobial resistanceDoxycyclineMicrobiomeOcular rosaceaSub-microbial

Identifiers

PMID36539810
PMCPMC9769060
OpenAlexW4312114679

What OpenQuestion holds

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LicenceCC BY
Read underepoch 390

Registered trials

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.