Evidence map›Paper›PMID 20307214›Full record

Trial reportJournal of ocular pharmacology and therapeutics : the official journal of the Association for Ocular Pharmacology and Therapeutics2010

A randomized, placebo-controlled clinical trial of tacrolimus ophthalmic suspension 0.1% in severe allergic conjunctivitis.

Yuichi Ohashi, Nobuyuki Ebihara, Hiroshi Fujishima, Atsuki Fukushima, Naoki Kumagai, Yayoi Nakagawa, Kenichi Namba, Shigeki Okamoto, Jun Shoji, Etsuko Takamura and 1 more

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

Trial report in Journal of ocular pharmacology and therapeutics : the official journal of the Association for Ocular Pharmacology and Therapeutics, 2010. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT01850979 (Treatment of Dry Eye Using 0.03% Tacrolimus Eye Drops), which is not on this map. Cited by 53 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
53citing papers in PubMed, 1 pooled it
10.6field-weighted citation impact, top 1% 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.

NCT01850979 phase4completednot on this map

Treatment of Dry Eye Using 0.03% Tacrolimus Eye Drops: Prospective Double-Blind Randomized Study

TypeinterventionalSponsorUniversity of Sao Paulo General HospitalRan2010 to 2011Enrolled24ConditionsSjogren Syndrome, Dry Eye SyndromeArmsTacrolimus, Olive Oil
3 · Its place in the literature

Who cites it

53 citing papers in PubMed, 1 synthesis or guideline pooled it, 178 citations in OpenAlex.

  1. Pooled it
  2. Trial
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  6. Review
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  9. Topical tacrolimus versus dexamethasone in managing shield ulcer of vernal keratoconjunctivitis.Medical hypothesis, discovery & innovation ophthalmology journal · 2024
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  15. A comparative study between ciclosporine A eye drop (2%) and tacrolimus eye ointment (0.03%) in management of children with refractory vernal keratoconjunctivitis.Graefe's archive for clinical and experimental ophthalmology = Albrecht von Graefes Archiv fur klinische und experimentelle Ophthalmologie · 2022
    Article
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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 10 institutions in 1 country.

Yuichi OhashiDepartment of Ophthalmology, University of Ehime School of Medicine, Shizukawa, Toon City Ehime, 7910295, Japan. ohashi@m.ehime-u.ac.jp
Nobuyuki Ebihara
Hiroshi Fujishima
Atsuki Fukushima
Naoki Kumagai
Yayoi Nakagawa
Kenichi Namba
Shigeki Okamoto
Jun Shoji
Etsuko Takamura
Kunihiko Hayashi
Akebono Clinic · JPEhime University · JPGunma University · JPHokkaido University · JPJuntendo University · JPKochi Medical School Hospital · JPMita Hospital · JPNihon University · JPNishi Eye Hospital · JPTokyo Women's Medical University · JP

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

aimsTo examine the efficacy of tacrolimus ophthalmic suspension 0.1% in treating severe allergic conjunctivitis.

methodsThis was a multicenter, randomized, double-masked, placebo-controlled clinical trial. Fifty-six patients with severe allergic conjunctivitis in whom topical antiallergic agents and corticosteroids had been ineffective were randomized to tacrolimus or placebo treatment. Patients were treated either with tacrolimus or placebo twice-daily for 4 weeks. Severity of objective signs in palpebral and bulbar conjunctiva, limbus, and corneal involvement was assessed using 4 grades. Seven subjective symptoms were evaluated by visual analog scale (VAS) assessment. The primary efficacy endpoint was change in the total score of objective signs at the end of treatment. The secondary efficacy endpoints included change in the score for each objective sign and change in the VAS for each subjective symptom. Safety was assessed based on the severity and the incidence of adverse events.

resultsMean change from baseline in total score for objective signs was significantly greater in the tacrolimus (-5.6 + or - 5.1) than in the placebo group (-0.1 + or - 4.5; P < 0.001). Tacrolimus significantly improved giant papillae (P = 0.001) and corneal involvement (P = 0.005). Five subjective symptoms (itching, discharge, hyperemia, lacrimation, and foreign body sensation) were significantly better in the tacrolimus than in the placebo group. The most frequent treatment-related adverse event in the tacrolimus group was mild ocular irritation upon topical instillation, which was well-tolerated.

conclusionTacrolimus ophthalmic suspension 0.1% is effective in treating severe allergic conjunctivitis.

Indexed as

AdolescentConjunctivitis, AllergicDouble-Blind MethodFemaleHumansImmunosuppressive AgentsIncidenceMaleOphthalmic SolutionsSickness Impact ProfileTacrolimusTreatment OutcomeImmunosuppressive AgentsOphthalmic SolutionsTacrolimus

Identifiers

PMID20307214
PMCPMC3158389
OpenAlexW2038075308

What OpenQuestion holds

Textmetadata
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.