Evidence map›Paper›PMID 31389210›Full record

Trial reportKorean journal of ophthalmology : KJO2019

Efficacy of Topical Cyclosporine Nanoemulsion 0.05% Compared with Topical Cyclosporine Emulsion 0.05% and Diquafosol 3% in Dry Eye.

Chang Hyun Park, Mee Kum Kim, Eun Chul Kim, Jae Yong Kim, Tae Im Kim, Hong Kyun Kim, Jong Suk Song, Kyung Chul Yoon, Do Hyung Lee, Hyung Keun Lee and 3 more

Abstract readClinical Trial, Phase IVMulticenter StudyRandomized Controlled Trial
In one paragraph

Trial report in Korean journal of ophthalmology : KJO, 2019. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 13 papers, 2 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
13citing papers in PubMed, 2 pooled it
–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

13 citing papers in PubMed, 2 syntheses or guidelines pooled it.

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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

13 authors.

Chang Hyun ParkDepartment of Ophthalmology, Yeouido St. Mary's Hospital, The Catholic University of Korea College of Medicine, Seoul, Korea.
Mee Kum KimDepartment of Ophthalmology, Seoul National University Hospital, Seoul National University College of Medicine, Seoul, Korea.
Eun Chul KimDepartment of Ophthalmology, Bucheon St. Mary's Hospital, The Catholic University of Korea College of Medicine, Bucheon, Korea.
Jae Yong KimDepartment of Ophthalmology, Asan Medical Center, University of Ulsan College of Medicine, Seoul, Korea.
Tae Im KimDepartment of Ophthalmology, Institute of Vision Research, Severance Hospital, Yonsei University College of Medicine, Seoul, Korea.
Hong Kyun KimDepartment of Ophthalmology, Kyungpook National University School of Medicine, Daegu, Korea.
Jong Suk SongDepartment of Ophthalmology, Korea University College of Medicine, Seoul, Korea.
Kyung Chul YoonDepartment of Ophthalmology, Chonnam National University Medical School, Gwangju, Korea.
Do Hyung LeeDepartment of Ophthalmology, Ilsan Paik Hospital, Inje University College of Medicine, Goyang, Korea.
Hyung Keun LeeDepartment of Ophthalmology, Institute of Vision Research, Gangnam Severance Hospital, Yonsei University College of Medicine, Seoul, Korea.
Tae Young ChungDepartment of Ophthalmology, Samsung Medical Center, Sungkyunkwan University School of Medicine, Seoul, Korea.
Chul Young ChoiDepartment of Ophthalmology, Kangbuk Samsung Hospital, Sungkyunkwan University School of Medicine, Seoul, Korea.
Hyun Seung KimDepartment of Ophthalmology, Yeouido St. Mary's Hospital, The Catholic University of Korea College of Medicine, Seoul, Korea. sara514@catholic.ac.kr.

Funding

Taejoon Pharm
6 · The paper itself

Abstract

purposeTo evaluate the efficacy and safety of cyclosporine nanoemulsion 0.05% compared to cyclosporine emulsion 0.05% and diquafosol sodium 3%.

methodsThis was a multicenter, randomized, evaluator-masked, active control, parallel, phase IV study. A total of 227 patients were randomly allocated to instill cyclosporine nanoemulsion 0.05% (CN) twice daily, cyclosporine emulsion 0.05% (CE) twice daily, or diquafosol sodium 3% (DQ) six times daily. Non-inferiority of CN was analyzed by primary endpoint (cornea and conjunctival staining scores at week 12). The secondary endpoints were scores of corneal staining, conjunctival staining, tear break-up time, Schirmer test, and Ocular Surface Disease Index at weeks 4 and 12.

resultsPrimary endpoints showed statistically significant improvements in all groups. Primary endpoints were -6.60 for the CN group, -5.28 for the CE group, and -6.63 for the DQ group (National Eye Institute scale from 0 to 33), verifying the non-inferiority of CN compared to CE (95% confidence interval, -0.15 to 2.80, Δ>-2.88). In intergroup comparison between CN and CE groups, the CN group had significantly more decreased conjunctival staining score at week 12. Intergroup comparison between CN and DQ groups showed consistent statistically significant improvements in TBUT and Schirmer test in the CN group. In the DQ group, TBUT showed late statistically significant improvement at week 12 and Schirmer test showed relatively short-term statistically significant improvement at week 4.

conclusionsCyclosporine nanoemulsion 0.05% was equivalently efficient compared to cyclosporine emulsion 0.05% and diquafosol sodium 3%. In addition, CN showed significant improvements in several parameters for treatment of dry eyes.

Indexed as

Administration, TopicalAdultCyclosporineDose-Response Relationship, DrugDry Eye SyndromesEmulsionsFemaleFollow-Up StudiesHumansImmunosuppressive AgentsMaleMiddle AgedNanotechnologyPolyphosphatesProspective StudiesSingle-Blind MethodCyclosporinediquafosolEmulsionsImmunosuppressive AgentsPolyphosphatesUracil NucleotidesCyclosporineDiquafosolDry eye syndromesNanotechnology

Identifiers

PMID31389210
PMCPMC6685820

What OpenQuestion holds

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LicenceCC BY-NC
Read underepoch 390

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.