Evaluation of Clinical Efficacy and Safety of a Novel Cyclosporin A Nanoemulsion in the Treatment of Dry Eye Syndrome

Hyun Seung Kim, Tae-im Kim, Jin Hyoung Kim, Kyung Chul Yoon, Joon Young Hyon, Ko Un Shin, Chul Young Choi

Research output: Contribution to journalArticle

4 Citations (Scopus)

Abstract

Purpose: Topical administration of the anti-inflammatory agent cyclosporin A (CsA) is recommended for long-Term management of dry eye syndrome (DES), yet standard ophthalmic CsA preparations have been reported to be unstable. In this trial, the efficacy and safety of Clacier™ (based on a phase 3 study developed by Huons Co. Ltd.), a novel 0.05% CsA nanoemulsion formulation, are compared with those of the conventional Restasis® emulsion. Methods: Patients with moderate-To-severe DES were randomly assigned to receive topical 0.05% CsA in the form of Clacier or Restasis, to be administered twice daily for 12 weeks. The primary efficacy outcome was the change from baseline in corneal fluorescein staining scores at week 12; changes at weeks 4 and 8 were secondary endpoints. Additional endpoints included score changes from baseline in nonanesthetic Schirmer's test I, tear breakup time, ocular surface disease index, and conjunctival staining. Results: At week 12, corneal staining scores were improved in patients treated with Clacier and Restasis, with no significant difference between treatments (P = 0.41). Temporal conjunctival surface damage was significantly more ameliorated with Clacier treatment than with Restasis treatment (P = 0.034). Notably, tear film stability was improved more rapidly in Clacier patients at week 4 (P = 0.005) than in Restasis patients (P = 0.36). Improvements in tear production were comparable with both Clacier and Restasis treatments. Clacier did not increase the risk of adverse events as compared with Restasis. Conclusion: Treatment with Clacier alleviated clinical signs and symptoms of DES comparably to the commercially available Restasis, resulting in improved quality of life for patients. Clacier is an effective and safe therapeutic agent for DES.

Original languageEnglish
Pages (from-to)530-538
Number of pages9
JournalJournal of Ocular Pharmacology and Therapeutics
Volume33
Issue number7
DOIs
Publication statusPublished - 2017 Sep 1

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Dry Eye Syndromes
Cyclosporine
Safety
Tears
Staining and Labeling
Therapeutics
Topical Administration
Eye Diseases
Emulsions
Fluorescein
Signs and Symptoms
Anti-Inflammatory Agents
Quality of Life

All Science Journal Classification (ASJC) codes

  • Ophthalmology
  • Pharmacology
  • Pharmacology (medical)

Cite this

Kim, Hyun Seung ; Kim, Tae-im ; Kim, Jin Hyoung ; Yoon, Kyung Chul ; Hyon, Joon Young ; Shin, Ko Un ; Choi, Chul Young. / Evaluation of Clinical Efficacy and Safety of a Novel Cyclosporin A Nanoemulsion in the Treatment of Dry Eye Syndrome. In: Journal of Ocular Pharmacology and Therapeutics. 2017 ; Vol. 33, No. 7. pp. 530-538.
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Evaluation of Clinical Efficacy and Safety of a Novel Cyclosporin A Nanoemulsion in the Treatment of Dry Eye Syndrome. / Kim, Hyun Seung; Kim, Tae-im; Kim, Jin Hyoung; Yoon, Kyung Chul; Hyon, Joon Young; Shin, Ko Un; Choi, Chul Young.

In: Journal of Ocular Pharmacology and Therapeutics, Vol. 33, No. 7, 01.09.2017, p. 530-538.

Research output: Contribution to journalArticle

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T1 - Evaluation of Clinical Efficacy and Safety of a Novel Cyclosporin A Nanoemulsion in the Treatment of Dry Eye Syndrome

AU - Kim, Hyun Seung

AU - Kim, Tae-im

AU - Kim, Jin Hyoung

AU - Yoon, Kyung Chul

AU - Hyon, Joon Young

AU - Shin, Ko Un

AU - Choi, Chul Young

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N2 - Purpose: Topical administration of the anti-inflammatory agent cyclosporin A (CsA) is recommended for long-Term management of dry eye syndrome (DES), yet standard ophthalmic CsA preparations have been reported to be unstable. In this trial, the efficacy and safety of Clacier™ (based on a phase 3 study developed by Huons Co. Ltd.), a novel 0.05% CsA nanoemulsion formulation, are compared with those of the conventional Restasis® emulsion. Methods: Patients with moderate-To-severe DES were randomly assigned to receive topical 0.05% CsA in the form of Clacier or Restasis, to be administered twice daily for 12 weeks. The primary efficacy outcome was the change from baseline in corneal fluorescein staining scores at week 12; changes at weeks 4 and 8 were secondary endpoints. Additional endpoints included score changes from baseline in nonanesthetic Schirmer's test I, tear breakup time, ocular surface disease index, and conjunctival staining. Results: At week 12, corneal staining scores were improved in patients treated with Clacier and Restasis, with no significant difference between treatments (P = 0.41). Temporal conjunctival surface damage was significantly more ameliorated with Clacier treatment than with Restasis treatment (P = 0.034). Notably, tear film stability was improved more rapidly in Clacier patients at week 4 (P = 0.005) than in Restasis patients (P = 0.36). Improvements in tear production were comparable with both Clacier and Restasis treatments. Clacier did not increase the risk of adverse events as compared with Restasis. Conclusion: Treatment with Clacier alleviated clinical signs and symptoms of DES comparably to the commercially available Restasis, resulting in improved quality of life for patients. Clacier is an effective and safe therapeutic agent for DES.

AB - Purpose: Topical administration of the anti-inflammatory agent cyclosporin A (CsA) is recommended for long-Term management of dry eye syndrome (DES), yet standard ophthalmic CsA preparations have been reported to be unstable. In this trial, the efficacy and safety of Clacier™ (based on a phase 3 study developed by Huons Co. Ltd.), a novel 0.05% CsA nanoemulsion formulation, are compared with those of the conventional Restasis® emulsion. Methods: Patients with moderate-To-severe DES were randomly assigned to receive topical 0.05% CsA in the form of Clacier or Restasis, to be administered twice daily for 12 weeks. The primary efficacy outcome was the change from baseline in corneal fluorescein staining scores at week 12; changes at weeks 4 and 8 were secondary endpoints. Additional endpoints included score changes from baseline in nonanesthetic Schirmer's test I, tear breakup time, ocular surface disease index, and conjunctival staining. Results: At week 12, corneal staining scores were improved in patients treated with Clacier and Restasis, with no significant difference between treatments (P = 0.41). Temporal conjunctival surface damage was significantly more ameliorated with Clacier treatment than with Restasis treatment (P = 0.034). Notably, tear film stability was improved more rapidly in Clacier patients at week 4 (P = 0.005) than in Restasis patients (P = 0.36). Improvements in tear production were comparable with both Clacier and Restasis treatments. Clacier did not increase the risk of adverse events as compared with Restasis. Conclusion: Treatment with Clacier alleviated clinical signs and symptoms of DES comparably to the commercially available Restasis, resulting in improved quality of life for patients. Clacier is an effective and safe therapeutic agent for DES.

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