Skip to content
DraconiticResearch
Search Sources API
203,234 studies31 sourcesUpdated 45 min ago
Peer-reviewedCC BY 4.0PLOS One

Comparative study on the clinical effectiveness of low-concentration cyclosporine eye drops in patients with dry eye disease

  • Jae Hyun Kim1
  • Hui Kyung Kim2
  • Young-Joo Shin3
  • Chul Young Choi4
  • Hong Kyun Kim5
  • Eunchul Kim6
  • Jae Yong Kim7
  • Ji Eun Lee8
  • SunWoong Kim9
  • Moonwon Hwang10
  • Jong-Seok Song11
  • Dong Hyun Kim12
1 more authors
  • Jong Soo Lee
12 affiliations
  1. 1Department of Ophthalmology, Pusan National University School of Medicine, Busan, South Korea
  2. 2Department of Ophthalmology, Hallym University Kangnam Sacred Heart Hospital, Seoul, South Korea
  3. 3Department of Ophthalmology, Kangbuk Samsung Hospital, Seoul, South Korea
  4. 4Department of Ophthalmology, Kyungpook National University Hospital, Daegu, South Korea
  5. 5Department of Ophthalmology, The Catholic University of Korea, Bucheon ST. Mary’s Hospital, Bucheon, South Korea
  6. 6Department of Ophthalmology, Asan Medical Center, Seoul, South Korea
  7. 7Department of Ophthalmology, Pusan National University Yangsan Hospital, Yangsan, South Korea
  8. 8Department of Ophthalmology, Yonsei University Wonju Severance Christian Hospital, Wonju, South Korea
  9. 9Department of Ophthalmology, Inje University Busan Paik Hospital, Busan, South Korea
  10. 10Department of Ophthalmology, Korea University Guro Hospital, Seoul, South Korea
  11. 11Department of Ophthalmology, Korea University Anam Hospital, Seoul, South Korea
  12. 12Biomedical Research Institute, Pusan National University Hospital, Busan, South Korea
Open at sourcePDFDOICite

Abstract

Purpose: This study aimed to evaluate the efficacy and safety of low-concentration, nanoparticle-based cyclosporine eye drops (SCAI-001 0.01% and SCAI-001 0.02%) compared to those of the conventional Restasis® (cyclosporine 0.05%) emulsion for dry eye disease (DED). Methods: In this multicenter, randomized, double-blind, Phase 2 trial, patients with DED were assigned to three groups: SCAI-001 0.01%, SCAI-001 0.02%, and Restasis. The primary efficacy endpoint was the change in tear volume after 12 weeks. Secondary efficacy endpoints included changes in tear volume at 4 and 8 weeks, corneal and conjunctival surface staining scores, tear film breakup time (TBUT), standard patient evaluation of eye dryness questionnaire score (SPEED), and ocular surface disease index (OSDI) at 4, 8, and 12 weeks. Results: Tear volume increased in all groups at 12 weeks without intergroup differences. SCAI-001 0.01% and SCAI-001 0.02% achieved earlier improvements in tear volume at 4 weeks than that of Restasis, although no significant between-group difference was observed at any time point. Conjunctival surface scores improved in all groups at 4, 8, and 12 weeks, excluding 4 weeks of Restasis. Conjunctival staining improved to a greater extent with SCAI-001 0.01% than with Restasis at weeks 4 and 8. Corneal surface scores, TBUT, SPEED, and OSDI scores improved in all groups at 4, 8, and 12 weeks without intergroup differences. Conclusions: Low-concentration cyclosporine (SCAI-001 0.01% and SCAI-001 0.02%) demonstrated efficacy and safety comparable to that of Restasis in improving DED measures. Trial registration: ClinicalTrials.gov Identifier: NCT05733624.

Related

  1. Effectiveness of 0.05% cyclosporine A eye drops for dry eye disease in patients with thyroid-associated ophthalmopathy: a prospective, parallel-group cohort study.
    Yu Zhang, Juan Bao, Cuiyu Wang +3
    Frontiers in medicinePeer-reviewedCC BYFull textEpidemiology & public healthEurope PMC
  2. Why do patients bypass primary care? Trust, resource concentration, and risk in China's tiered healthcare system: A comparative policy perspective
    Jingyi Ma, Lingbo Wei, Fei Ma
    Global Health & MedicinePeer-reviewedLicence not statedFull textGeneral medicinePMC
  3. Comparative Effectiveness of Low-Dose Intra-Articular Ozone Therapy for Pain and Functional Outcomes in Patients with Knee Osteoarthritis: A Retrospective Cohort Study [Response to Letter].
    Arzu Dinç Yavaş, Sümeyye Akçay
    Journal of pain researchPeer-reviewedCC BY-NCFull textPharmacology & toxicologyEurope PMC
  4. Comparative evaluation of effectiveness of two different in-office vital bleaching agents in treating dental fluorosis - Randomized clinical trial
    Udaya Rekha Mada, Srinivasulu Gomasani, R.V.S. Krishna Kumar +1
    Journal of Dr. NTR University of Health SciencesPeer-reviewedCC BY-NC-SAFull textGeneral medicineDOAJ
  5. TeleBACK clinical trial: comparing the effectiveness of telerehabilitation and in-clinic physical therapy for patients with chronic low back pain - protocol for a multicentre, pragmatic, individually randomised group treatment trial.
    Kevin H McLaughlin, Julie M Fritz, Kate I Minick +9
    BMJ openPeer-reviewedCC BY-NCFull textPharmacology & toxicologyEurope PMCCrossref

Cite

BibTeXRIS
BibTeX
@article{kim2026comparative,
  title = {{Comparative study on the clinical effectiveness of low-concentration cyclosporine eye drops in patients with dry eye disease}},
  author = {Jae Hyun Kim and Hui Kyung Kim and Young-Joo Shin and Chul Young Choi and Hong Kyun Kim and Eunchul Kim and Jae Yong Kim and Ji Eun Lee and SunWoong Kim and Moonwon Hwang and Jong-Seok Song and Dong Hyun Kim and Jong Soo Lee},
  journal = {PLOS One},
  year = {2026},
  month = sep,
  doi = {10.1371/journal.pone.0358007},
  url = {https://doi.org/10.1371/journal.pone.0358007},
  note = {CC BY 4.0},
}
RIS
TY  - JOUR
TI  - Comparative study on the clinical effectiveness of low-concentration cyclosporine eye drops in patients with dry eye disease
AU  - Jae Hyun Kim
AU  - Hui Kyung Kim
AU  - Young-Joo Shin
AU  - Chul Young Choi
AU  - Hong Kyun Kim
AU  - Eunchul Kim
AU  - Jae Yong Kim
AU  - Ji Eun Lee
AU  - SunWoong Kim
AU  - Moonwon Hwang
AU  - Jong-Seok Song
AU  - Dong Hyun Kim
AU  - Jong Soo Lee
PY  - 2026
DA  - 2026/09/28
JO  - PLOS One
DO  - 10.1371/journal.pone.0358007
UR  - https://doi.org/10.1371/journal.pone.0358007
AB  - Purpose: This study aimed to evaluate the efficacy and safety of low-concentration, nanoparticle-based cyclosporine eye drops (SCAI-001 0.01% and SCAI-001 0.02%) compared to those of the conventional Restasis® (cyclosporine 0.05%) emulsion for dry eye disease (DED). Methods: In this multicenter, randomized, double-blind, Phase 2 trial, patients with DED were assigned to three groups: SCAI-001 0.01%, SCAI-001 0.02%, and Restasis. The primary efficacy endpoint was the change in tear volume after 12 weeks. Secondary efficacy endpoints included changes in tear volume at 4 and 8 weeks, corneal and conjunctival surface staining scores, tear film breakup time (TBUT), standard patient evaluation of eye dryness questionnaire score (SPEED), and ocular surface disease index (OSDI) at 4, 8, and 12 weeks. Results: Tear volume increased in all groups at 12 weeks without intergroup differences. SCAI-001 0.01% and SCAI-001 0.02% achieved earlier improvements in tear volume at 4 weeks than that of Restasis, although no significant between-group difference was observed at any time point. Conjunctival surface scores improved in all groups at 4, 8, and 12 weeks, excluding 4 weeks of Restasis. Conjunctival staining improved to a greater extent with SCAI-001 0.01% than with Restasis at weeks 4 and 8. Corneal surface scores, TBUT, SPEED, and OSDI scores improved in all groups at 4, 8, and 12 weeks without intergroup differences. Conclusions: Low-concentration cyclosporine (SCAI-001 0.01% and SCAI-001 0.02%) demonstrated efficacy and safety comparable to that of Restasis in improving DED measures. Trial registration: ClinicalTrials.gov Identifier: NCT05733624.
SN  - 1932-6203
ER  -