Comparison of 0.05% cyclosporine and 3% diquafosol solution for dry eye patients

A randomized, blinded, multicenter clinical trial

Chang Hyun Park, Hyung Keun Lee, Mee Kum Kim, Eun Chul Kim, Jae Yong Kim, Tae Im Kim, Hong Kyun Kim, Jong Suk Song, Kyung Chul Yoon, Do Hyung Lee, Tae Young Chung, Chul Young Choi, Hyun Seung Kim

Research output: Contribution to journalArticleResearchpeer-review

Abstract

Background: This study is aim to compare the clinical effectiveness between the two most prominent dry eye disease (DED)-specific eye drops, 0.05% cyclosporine (CN) and 3% diquafosol (DQ). Methods: This is a multi-centered, randomized, masked, prospective clinical study. A total of 153 DED patients were randomly allocated to use CN twice per day or DQ six times daily. Cornea and conjunctival staining scores (NEI scale), tear break-up time (TBUT), Schirmer test scores, and ocular surface disease index (OSDI) score were measured at baseline, 4 and 12 weeks after treatment. Results: At 12 weeks after treatment, NEI scaled scores were significantly reduced from the baseline by - 6.60 for CN and - 6.63 for DQ group (all P < 0.0001, P = 0.9739 between groups). TBUT and Schirmer values for CN were significantly improved from the baseline at 4 and 12 weeks (P = 0.0034, P < 0.0001 for TBUT, P = 0.0418, P = 0.0031 for Schirmer test). However, for DQ, TBUT showed significant improvement at 12 weeks only (P = 0.0281). Mean OSDI score differences from the baseline to 12 weeks were improved by - 13.03 ± 19.63 for CN and - 16.11 ± 20.87 for DQ, respectively (all P < 0.0001, P = 0.854 between groups). Regarding drug compliance, the mean instillation frequency of CN was less than that of DQ (P < 0.001). There were no statistically significant intergroup differences in safety evaluation. Conclusions: The level of improvement regarding NEI, TBUT, and OSDI scores were not significantly different between the two treatment groups. However, with regards to the early improvement of TBUT and patient compliance, patients using CN improved faster and with greater adherence to drug usage than did those treated with DQ. Trial registration: KCT0002180, retrospectively registered on 23 December 2016.

Original languageEnglish
Article number131
JournalBMC Ophthalmology
Volume19
Issue number1
DOIs
StatePublished - 17 Jun 2019

Fingerprint

Cyclosporine
Multicenter Studies
Tears
Eye Diseases
Clinical Trials
Ophthalmic Solutions
Patient Compliance
diquafosol
Pharmaceutical Preparations
Cornea
Therapeutics
Prospective Studies
Staining and Labeling
Safety

Keywords

  • Cyclosporine
  • Diquafosol
  • Dry eye disease
  • Ocular surface disease index
  • Schirmer's test
  • Tear break-up time

Cite this

Park, Chang Hyun ; Lee, Hyung Keun ; Kim, Mee Kum ; Kim, Eun Chul ; Kim, Jae Yong ; Kim, Tae Im ; Kim, Hong Kyun ; Song, Jong Suk ; Yoon, Kyung Chul ; Lee, Do Hyung ; Chung, Tae Young ; Choi, Chul Young ; Kim, Hyun Seung. / Comparison of 0.05% cyclosporine and 3% diquafosol solution for dry eye patients : A randomized, blinded, multicenter clinical trial. In: BMC Ophthalmology. 2019 ; Vol. 19, No. 1.
@article{2d96fa2509c84090ac68b7aa5acb5a83,
title = "Comparison of 0.05{\%} cyclosporine and 3{\%} diquafosol solution for dry eye patients: A randomized, blinded, multicenter clinical trial",
abstract = "Background: This study is aim to compare the clinical effectiveness between the two most prominent dry eye disease (DED)-specific eye drops, 0.05{\%} cyclosporine (CN) and 3{\%} diquafosol (DQ). Methods: This is a multi-centered, randomized, masked, prospective clinical study. A total of 153 DED patients were randomly allocated to use CN twice per day or DQ six times daily. Cornea and conjunctival staining scores (NEI scale), tear break-up time (TBUT), Schirmer test scores, and ocular surface disease index (OSDI) score were measured at baseline, 4 and 12 weeks after treatment. Results: At 12 weeks after treatment, NEI scaled scores were significantly reduced from the baseline by - 6.60 for CN and - 6.63 for DQ group (all P < 0.0001, P = 0.9739 between groups). TBUT and Schirmer values for CN were significantly improved from the baseline at 4 and 12 weeks (P = 0.0034, P < 0.0001 for TBUT, P = 0.0418, P = 0.0031 for Schirmer test). However, for DQ, TBUT showed significant improvement at 12 weeks only (P = 0.0281). Mean OSDI score differences from the baseline to 12 weeks were improved by - 13.03 ± 19.63 for CN and - 16.11 ± 20.87 for DQ, respectively (all P < 0.0001, P = 0.854 between groups). Regarding drug compliance, the mean instillation frequency of CN was less than that of DQ (P < 0.001). There were no statistically significant intergroup differences in safety evaluation. Conclusions: The level of improvement regarding NEI, TBUT, and OSDI scores were not significantly different between the two treatment groups. However, with regards to the early improvement of TBUT and patient compliance, patients using CN improved faster and with greater adherence to drug usage than did those treated with DQ. Trial registration: KCT0002180, retrospectively registered on 23 December 2016.",
keywords = "Cyclosporine, Diquafosol, Dry eye disease, Ocular surface disease index, Schirmer's test, Tear break-up time",
author = "Park, {Chang Hyun} and Lee, {Hyung Keun} and Kim, {Mee Kum} and Kim, {Eun Chul} and Kim, {Jae Yong} and Kim, {Tae Im} and Kim, {Hong Kyun} and Song, {Jong Suk} and Yoon, {Kyung Chul} and Lee, {Do Hyung} and Chung, {Tae Young} and Choi, {Chul Young} and Kim, {Hyun Seung}",
year = "2019",
month = "6",
day = "17",
doi = "10.1186/s12886-019-1136-8",
language = "English",
volume = "19",
journal = "BMC ophthalmology",
issn = "1471-2415",
publisher = "BioMed Central Ltd.",
number = "1",

}

Park, CH, Lee, HK, Kim, MK, Kim, EC, Kim, JY, Kim, TI, Kim, HK, Song, JS, Yoon, KC, Lee, DH, Chung, TY, Choi, CY & Kim, HS 2019, 'Comparison of 0.05% cyclosporine and 3% diquafosol solution for dry eye patients: A randomized, blinded, multicenter clinical trial', BMC Ophthalmology, vol. 19, no. 1, 131. https://doi.org/10.1186/s12886-019-1136-8

Comparison of 0.05% cyclosporine and 3% diquafosol solution for dry eye patients : A randomized, blinded, multicenter clinical trial. / Park, Chang Hyun; Lee, Hyung Keun; Kim, Mee Kum; Kim, Eun Chul; Kim, Jae Yong; Kim, Tae Im; Kim, Hong Kyun; Song, Jong Suk; Yoon, Kyung Chul; Lee, Do Hyung; Chung, Tae Young; Choi, Chul Young; Kim, Hyun Seung.

In: BMC Ophthalmology, Vol. 19, No. 1, 131, 17.06.2019.

Research output: Contribution to journalArticleResearchpeer-review

TY - JOUR

T1 - Comparison of 0.05% cyclosporine and 3% diquafosol solution for dry eye patients

T2 - A randomized, blinded, multicenter clinical trial

AU - Park, Chang Hyun

AU - Lee, Hyung Keun

AU - Kim, Mee Kum

AU - Kim, Eun Chul

AU - Kim, Jae Yong

AU - Kim, Tae Im

AU - Kim, Hong Kyun

AU - Song, Jong Suk

AU - Yoon, Kyung Chul

AU - Lee, Do Hyung

AU - Chung, Tae Young

AU - Choi, Chul Young

AU - Kim, Hyun Seung

PY - 2019/6/17

Y1 - 2019/6/17

N2 - Background: This study is aim to compare the clinical effectiveness between the two most prominent dry eye disease (DED)-specific eye drops, 0.05% cyclosporine (CN) and 3% diquafosol (DQ). Methods: This is a multi-centered, randomized, masked, prospective clinical study. A total of 153 DED patients were randomly allocated to use CN twice per day or DQ six times daily. Cornea and conjunctival staining scores (NEI scale), tear break-up time (TBUT), Schirmer test scores, and ocular surface disease index (OSDI) score were measured at baseline, 4 and 12 weeks after treatment. Results: At 12 weeks after treatment, NEI scaled scores were significantly reduced from the baseline by - 6.60 for CN and - 6.63 for DQ group (all P < 0.0001, P = 0.9739 between groups). TBUT and Schirmer values for CN were significantly improved from the baseline at 4 and 12 weeks (P = 0.0034, P < 0.0001 for TBUT, P = 0.0418, P = 0.0031 for Schirmer test). However, for DQ, TBUT showed significant improvement at 12 weeks only (P = 0.0281). Mean OSDI score differences from the baseline to 12 weeks were improved by - 13.03 ± 19.63 for CN and - 16.11 ± 20.87 for DQ, respectively (all P < 0.0001, P = 0.854 between groups). Regarding drug compliance, the mean instillation frequency of CN was less than that of DQ (P < 0.001). There were no statistically significant intergroup differences in safety evaluation. Conclusions: The level of improvement regarding NEI, TBUT, and OSDI scores were not significantly different between the two treatment groups. However, with regards to the early improvement of TBUT and patient compliance, patients using CN improved faster and with greater adherence to drug usage than did those treated with DQ. Trial registration: KCT0002180, retrospectively registered on 23 December 2016.

AB - Background: This study is aim to compare the clinical effectiveness between the two most prominent dry eye disease (DED)-specific eye drops, 0.05% cyclosporine (CN) and 3% diquafosol (DQ). Methods: This is a multi-centered, randomized, masked, prospective clinical study. A total of 153 DED patients were randomly allocated to use CN twice per day or DQ six times daily. Cornea and conjunctival staining scores (NEI scale), tear break-up time (TBUT), Schirmer test scores, and ocular surface disease index (OSDI) score were measured at baseline, 4 and 12 weeks after treatment. Results: At 12 weeks after treatment, NEI scaled scores were significantly reduced from the baseline by - 6.60 for CN and - 6.63 for DQ group (all P < 0.0001, P = 0.9739 between groups). TBUT and Schirmer values for CN were significantly improved from the baseline at 4 and 12 weeks (P = 0.0034, P < 0.0001 for TBUT, P = 0.0418, P = 0.0031 for Schirmer test). However, for DQ, TBUT showed significant improvement at 12 weeks only (P = 0.0281). Mean OSDI score differences from the baseline to 12 weeks were improved by - 13.03 ± 19.63 for CN and - 16.11 ± 20.87 for DQ, respectively (all P < 0.0001, P = 0.854 between groups). Regarding drug compliance, the mean instillation frequency of CN was less than that of DQ (P < 0.001). There were no statistically significant intergroup differences in safety evaluation. Conclusions: The level of improvement regarding NEI, TBUT, and OSDI scores were not significantly different between the two treatment groups. However, with regards to the early improvement of TBUT and patient compliance, patients using CN improved faster and with greater adherence to drug usage than did those treated with DQ. Trial registration: KCT0002180, retrospectively registered on 23 December 2016.

KW - Cyclosporine

KW - Diquafosol

KW - Dry eye disease

KW - Ocular surface disease index

KW - Schirmer's test

KW - Tear break-up time

UR - http://www.scopus.com/inward/record.url?scp=85067474707&partnerID=8YFLogxK

U2 - 10.1186/s12886-019-1136-8

DO - 10.1186/s12886-019-1136-8

M3 - Article

VL - 19

JO - BMC ophthalmology

JF - BMC ophthalmology

SN - 1471-2415

IS - 1

M1 - 131

ER -