Evidence map›Paper›PMID 29602567›Full record

Trial reportOphthalmology2018

Determinants of Outcomes of Adenoviral Keratoconjunctivitis.

Cecilia S Lee, Aaron Y Lee, Lakshmi Akileswaran, David Stroman, Kathryn Najafi-Tagol, Steve Kleiboeker, James Chodosh, Amalia Magaret, Anna Wald, Russell N Van Gelder and 1 more

Registry-linked trialOpen access · greenAbstract readMulticenter StudyRandomized Controlled Trial
In one paragraph

Trial report in Ophthalmology, 2018. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT01877694 (A Multicenter, Randomized Study of the Efficacy and Safety of Auriclosene), which is not on this map. Cited by 34 papers.

0numbers the graph read from it
0cells of the map it votes in
34citing papers in PubMed
5.2field-weighted citation impact, top 4% 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.

NCT01877694 phase2completednot on this map

A Multicenter, Randomized Study of the Efficacy and Safety of Auriclosene (NVC-422) Ophthalmic Solution 0.3% for the Treatment of Bacterial Conjunctivitis

TypeinterventionalSponsorNovaBay Pharmaceuticals, Inc.Ran2013 to 2015Enrolled217ConditionsBacterial ConjunctivitisArmsAuriclosene Solution 0.3%, Auriclosene Vehicle
3 · Its place in the literature

Who cites it

34 citing papers in PubMed, 57 citations in OpenAlex.

  1. Trial
  2. Trial
  3. Trial
  4. Article
  5. Review
  6. Review
  7. The Emergence Potential ofArchives of Razi Institute · 2024
    Review
  8. Natural history of adenoviral conjunctivitis in a US-based population: Viral load, signs, and symptoms.Contact lens & anterior eye : the journal of the British Contact Lens Association · 2024
    Article
  9. Article
  10. Article
  11. Article
  12. Article
  13. Article
  14. Review
  15. Article
  16. Article
  17. First Record of HAdV-D20 Among Keratoconjunctivitis Patients in Iraq.Reports of biochemistry & molecular biology · 2022
    Article
  18. Review
  19. Article
  20. Review
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

11 authors at 3 institutions in 1 country.

Cecilia S LeeDepartment of Ophthalmology, University of Washington, Seattle, Washington. Electronic address: leecs2@uw.edu.
Aaron Y LeeDepartment of Ophthalmology, University of Washington, Seattle, Washington.
Lakshmi AkileswaranDepartment of Ophthalmology, University of Washington, Seattle, Washington.
David StromanNovaBay Pharmaceuticals, Inc., Emeryville, California.
Kathryn Najafi-TagolNovaBay Pharmaceuticals, Inc., Emeryville, California.
Steve KleiboekerViracor Eurofins Clinical Diagnostics, Lee's Summit, Missouri.
James ChodoshDepartment of Ophthalmology, Massachusetts Eye and Ear Infirmary, Harvard Medical School, Boston, Massachusetts.
Amalia MagaretDepartment of Biostatistics, University of Washington, Seattle, Washington; Department of Laboratory Medicine, University of Washington, Seattle, Washington; Vaccine and Infectious Diseases Division, Fred Hutchinson Cancer Research Center, Seattle, Washington.
Anna WaldVaccine and Infectious Diseases Division, Fred Hutchinson Cancer Research Center, Seattle, Washington; Department of Medicine, University of Washington, Seattle, Washington; Department of Epidemiology, University of Washington, Seattle, Washington.
Russell N Van GelderDepartment of Ophthalmology, University of Washington, Seattle, Washington; Departments of Biological Structure and Pathology, University of Washington, Seattle, Washington.
BAYnovation Study Group
University of Washington · USNovaBay Pharmaceuticals (United States) · USMassachusetts Eye and Ear Infirmary · US

Funding

Vision Research CoreP30EY001730 · NEI · UNIVERSITY OF WASHINGTON · PI MAUREEN E NEITZ · 1985 to 2026
$23.5M
Immunopathogenesis of Adenovirus KeratitisR01EY013124 · NEI · UNIVERSITY OF OKLAHOMA HLTH SCIENCES CTR · PI James Chodosh, Jaya Rajaiya · 2001 to 2026
$10.8M
Clinical Research in HSV InfectionsK24AI071113 · NIAID · UNIVERSITY OF WASHINGTON · PI WALD, ANNA · 2006 to 2015
$1.7M
The ocular surface microbiome in potentially infectious ophthalmic diseaseK23EY024921 · NEI · UNIVERSITY OF WASHINGTON · PI LEE, CECILIA SUNGMIN · 2015 to 2019
$991k
Molecular epidemiology of adenoviral pathogenesis in keratoconjunctivitisR21EY027453 · NEI · UNIVERSITY OF WASHINGTON · PI VAN GELDER, RUSSELL N. · 2017 to 2018
$440k
NEI NIH HHS K23 EY024921NEI NIH HHS P30 EY001730NEI NIH HHS R01 EY013124NEI NIH HHS R21 EY027453NIAID NIH HHS K24 AI071113
6 · The paper itself

Abstract

purposeTo determine host and pathogen factors predictive of outcomes in a large clinical cohort with keratoconjunctivitis.

designRetrospective analyses of the clinical and molecular data from a randomized, controlled, masked trial for auricloscene for keratoconjunctivitis (NVC-422 phase IIB, NovaBay; clinicaltrials.gov identifier, NCT01877694).

participantsFive hundred participants from United States, India, Brazil, and Sri Lanka with clinical diagnosis of keratoconjunctivitis and positive rapid test results for adenovirus.

methodsClinical signs and symptoms and bilateral conjunctival swabs were obtained on days 1, 3, 6, 11, and 18. Polymerase chain reaction (PCR) analysis was performed to detect and quantify adenovirus in all samples. Regression models were used to evaluate the association of various variables with keratoconjunctivitis outcomes. Time to resolution of each symptom or sign was assessed by adenoviral species with Cox regression.

main outcome measuresThe difference in composite scores of clinical signs between days 1 and 18, mean visual acuity change between days 1 and 18, and time to resolution of each symptom or sign.

resultsOf 500 participants, 390 (78%) showed evidence of adenovirus by PCR. Among adenovirus-positive participants, adenovirus D species was most common (63% of total cases), but a total of 4 species and 21 different types of adenovirus were detected. Adenovirus D was associated with more severe signs and symptoms, a higher rate of subepithelial infiltrate development, and a slower decline in viral load compared with all other adenovirus species. The clinical courses of all patients with non-adenovirus D species infection and adenovirus-negative keratoconjunctivitis were similar. Mean change in visual acuity between days 1 and 18 was a gain of 1.9 letters; worse visual outcome was associated with older age.

conclusionsA substantial proportion of keratoconjunctivitis is not associated with a detectable adenovirus. The clinical course of those with adenovirus D keratoconjunctivitis is significantly more severe than those with non-adenovirus D species infections or adenovirus-negative keratoconjunctivitis; high viral load at presentation and non-United States origin of participants is associated with poorer clinical outcome.

Indexed as

AdenoviridaeAdenoviridae InfectionsAdolescentAdultAgedAged, 80 and overBrazilChildChild, PreschoolDNA, ViralEye Infections, ViralFemaleFollow-Up StudiesHumansIncidenceIndiaDNA, Viral

Identifiers

PMID29602567
PMCPMC6109430
OpenAlexW2795315227

What OpenQuestion holds

Textmetadata
LicenceTDM
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.