Evidence map›Paper›PMID 20304499›Full record

Trial reportOphthalmology2010

Treatment of dry eye syndrome with orally administered CF101: data from a phase 2 clinical trial.

Isaac Avni, Hanna J Garzozi, Irina S Barequet, Fanni Segev, David Varssano, Gil Sartani, Noa Chetrit, Erez Bakshi, David Zadok, Oren Tomkins and 11 more

2 registry-linked trialsOpen access · greenAbstract readClinical Trial, Phase IIMulticenter StudyRandomized Controlled Trial
In one paragraph

Trial report in Ophthalmology, 2010. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to 2 registered trials, which are not on this map. Cited by 40 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
40citing papers in PubMed, 1 pooled it
10.3field-weighted citation impact, top 2% 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.

NCT00349466 phase2completednot on this map

A Phase 2, Randomized, Double-Masked, Placebo-Controlled, Parallel-Group Study of the Safety and Efficacy of Daily CF101 Administered Orally in Patients With Moderate-to-Severe Keratoconjunctivitis Sicca

TypeinterventionalSponsorCan-Fite BioPharmaRan2007 to 2009Enrolled80ConditionsKeratoconjunctivitis SiccaArmsCF101, Placebo
NCT01235234 phase3completednot on this mapstarted 2011, after this paper: background citation

A Phase 3, Randomized, Double-Masked, Placebo-Controlled, Dose-Finding, Parallel-Group Study of the Safety and Efficacy of Daily CF101 Administered Orally in Patients With Moderate-to-Severe Dry Eye Disease

TypeinterventionalSponsorCan-Fite BioPharmaRan2011 to 2013Enrolled236ConditionsKeratoconjunctivitis SiccaArmsCF101
3 · Its place in the literature

Who cites it

40 citing papers in PubMed, 1 synthesis or guideline pooled it, 82 citations in OpenAlex.

  1. Pooled it
  2. Article
  3. Review
  4. Review
  5. Review
  6. Review
  7. Adenosine receptors as promising targets for the management of ocular diseases.Medicinal chemistry research : an international journal for rapid communications on design and mechanisms of action of biologically active agents · 2021
    Review
  8. Review
  9. Activation of adenosine ACell death & disease · 2020
    Article
  10. Review
  11. Article
  12. Review
  13. Review
  14. Article
  15. Article
  16. Novel Therapeutics in Glaucoma Management.Current neuropharmacology · 2018
    Review
  17. Review
  18. Ocular Purine Receptors as Drug Targets in the Eye.Journal of ocular pharmacology and therapeutics : the official journal of the Association for Ocular Pharmacology and Therapeutics · 2016
    Review
  19. Article
  20. Review
4 · The record

Corrections and comments

5 · Who and what money

Authors and funding

21 authors at 8 institutions in 2 countries.

Isaac AvniAssaf Harofe Medical Center, Zeriffin, Beer Yaakov, Israel.
Hanna J Garzozi
Irina S Barequet
Fanni Segev
David Varssano
Gil Sartani
Noa Chetrit
Erez Bakshi
David Zadok
Oren Tomkins
Gilad Litvin
Kenneth A Jacobson
Sari Fishman
Zivit Harpaz
Motti Farbstein
Sara Bar Yehuda
Michael H Silverman
William D Kerns
David R Bristol
Ilan Cohn
Pnina Fishman
Can-Fite BioPharma (Israel) · ILAssaf Harofeh Medical Center · ILBnai Zion Medical Center · ILMeir Medical Center · ILEmek Medical Center · ILNational Institutes of Health · USSheba Medical Center · ILTel Aviv Sourasky Medical Center · IL

Funding

Development Of Drugs Acting At Adenosine ReceptorsZIADK031117 · NIDDK · NATIONAL INSTITUTE OF DIABETES AND DIGESTIVE AND KIDNEY DISEASES · PI JACOBSON, KENNETH ALAN · 2009 to 2025
$10.4M
Intramural NIH HHS ZIA DK031117
6 · The paper itself

Abstract

objectiveTo explore the safety and efficacy of CF101, an A(3) adenosine receptor agonist, in patients with moderate to severe dry eye syndrome.

designPhase 2, multicenter, randomized, double-masked, placebo-controlled, parallel-group study.

participantsSixty-eight patients completed the study, 35 patients in the placebo group and 33 patients in the CF101 group.

interventionPatients were treated orally with either 1 mg CF101 pills or matching vehicle-filled placebo pills, given twice daily for 12 weeks, followed by a 2-week posttreatment observation.

main outcome measuresAn improvement of more than 25% over baseline at week 12 in one of the following parameters: (1) tear break-up time (BUT); (2) superficial punctate keratitis assessed by fluorescein staining results; and (3) Schirmer tear test 1 results. Clinical laboratory safety tests, ophthalmic examinations, intraocular pressure (IOP) measurements, electrocardiographic evaluations, vital sign measurements, and monitoring of adverse events.

resultsA statistically significant increase in the proportion of patients who achieved more than 25% improvement in the corneal staining and in the clearance of corneal staining was noted between the CF101-treated group and the placebo group. Treatment with CF101 resulted in a statistically significant improvement in the mean change from baseline at week 12 of the corneal staining, BUT, and tear meniscus (TM) height in the CF101-treated group. CF101 was well tolerated and exhibited an excellent safety profile with no serious adverse events. A statistically significant decrease from baseline was observed in the IOP of the CF101-treated group in comparison with the placebo group.

conclusionsCF101, given orally, induced a statistically significant improvement in the corneal staining and an improvement in the BUT and TM in patients with moderate to severe dry eye syndrome. The drug was very well tolerated. These data and the anti-inflammatory characteristic of CF101 support further study of the drug as a potential treatment for the signs and symptoms of dry eye syndrome. FINANCIAL DISCLOSURE(S): Proprietary or commercial disclosure may be found after the references.

Indexed as

Adenosine A3 Receptor AgonistsAdenosineAdministration, OralCorneaDouble-Blind MethodDry Eye SyndromesElectrocardiographyFemaleFluorophotometryHumansIntraocular PressureMaleMiddle AgedTearsTreatment OutcomeAdenosineAdenosine A3 Receptor AgonistsCF101

Identifiers

PMID20304499
PMCPMC3668568
OpenAlexW1594028947

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.