Evidence map›Paper›PMID 22157392›Full record

Trial reportEye & contact lens2012

Safety and efficacy of topical azithromycin ophthalmic solution 1.0% in the treatment of contact lens-related dry eye.

Jason J Nichols, Katherine M Bickle, Richard C Zink, Michael D Schiewe, Reza M Haque, Kelly K Nichols

Abstract readRandomized Controlled Trial
In one paragraph

Trial report in Eye & contact lens, 2012. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 10 papers.

0numbers the graph read from it
0cells of the map it votes in
10citing papers in PubMed
–field-weighted citation impact
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.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

10 citing papers in PubMed.

  1. Dual-Polymer Drops, Contact Lens Comfort, and Lid Wiper Epitheliopathy.Optometry and vision science : official publication of the American Academy of Optometry · 2016
    Trial
  2. Review
  3. Review
  4. Review
  5. Review
  6. Article
  7. New agents for treating dry eye syndrome.Current allergy and asthma reports · 2013
    Review
  8. Review
  9. Article
  10. An eye for azithromycin: review of the literature.Therapeutic advances in ophthalmology
    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

6 authors.

Jason J NicholsCollege of Optometry, University of Houston, Houston, TX 77204-2020, USA. jnichols@optometry.uh.edu
Katherine M Bickle
Richard C Zink
Michael D Schiewe
Reza M Haque
Kelly K Nichols

Funding

Dry Eye in PostmenopauseR01EY015519 · NEI · UNIVERSITY OF HOUSTON · PI NICHOLS, KELLY K · 2007 to 2011
$1.7M
Interferometric Studies of the Fluid Dynamics of the Tear FilmR01EY017951 · NEI · OHIO STATE UNIVERSITY · PI KING-SMITH, PETER E · 2009 to 2012
$1.2M
NEI NIH HHS EY007151NEI NIH HHS EY015519NEI NIH HHS EY017951NEI NIH HHS R01 EY015519
6 · The paper itself

Abstract

purposeThe purpose of this pilot study was to evaluate the safety and efficacy of azithromycin ophthalmic solution 1% in patients with contact lens-related dry eye (CLDE).

methodsThis was a 4-week, single-center, open-label clinical trial in patients diagnosed with CLDE using the Contact Lens Dry Eye Questionnaire (CLDEQ). Fifty patients were enrolled in this study. The patients were randomized to 1 of 2 treatment groups: azithromycin ophthalmic solution administered bid on days 1 and 2 and on days 3 to 29±1 or Visine for Contacts rewetting drops administered qid on days 1 to 29±1. The patient diaries were used daily to collect data on comfortable and total contact lens wear time and ocular dryness throughout the treatment period. Tear osmolarity, fluorescein corneal staining, and visual acuity were also assessed during clinic visits.

resultsFifty patients were enrolled, and 44 completed the study. One patient discontinued in the azithromycin group, and five patients discontinued in the rewetting drops group because of adverse events. A statistically significant increase in mean comfortable contact lens wear time from baseline was observed for the subjects treated with azithromycin ophthalmic solution as compared with the subjects treated with rewetting drops at week 4 (P=0.004; primary endpoint), in addition to weeks 2 and 3. The improvement in the mean comfortable wear time for the patients in the azithromycin treatment group exceeded 2 hrs throughout the treatment period (weeks 1-4). No significant differences were observed between the groups for total wear time, low contrast visual acuity, or tear osmolarity. Subject-rated ocular dryness (PM time assessments) was significantly improved from baseline in the subjects treated with azithromycin ophthalmic solution as compared with those treated with rewetting drops at weeks 2 and 3 endpoints (P=0.015 for each week). Additionally, a statistical difference was observed in favor of the azithromycin treatment group at week 2 for the subjects reclassifying as nondry eye as determined by the CLDEQ (P=0.05).

conclusionsTreatment with topical azithromycin ophthalmic solution was well tolerated and resulted in a significant improvement in comfortable contact lens wear time in the patients with CLDE.

Indexed as

Administration, TopicalAdolescentAdultAgedAnti-Bacterial AgentsAzithromycinContact LensesCorneaDry Eye SyndromesFemaleFluoresceinHumansImidazolesMaleMiddle AgedOphthalmic SolutionsAnti-Bacterial AgentsAzithromycinFluoresceinImidazolesOphthalmic Solutionstetrahydrozoline

Identifiers

PMID22157392
PMCPMC12990527

What OpenQuestion holds

Textmetadata
LicenceTDM
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Registered trials

None linked

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.