Hyun Seung Kim1, Tae-Im Kim2, Jin Hyoung Kim3, Kyung Chul Yoon4, Joon Young Hyon5, Ko Un Shin6, Chul Young Choi6. 1. 1 Department of Ophthalmology and Visual Science, College of Medicine, St. Mary's Hospital, The Catholic University , Seoul, Korea. 2. 2 Department of Ophthalmology, Vision Research Institute, Yonsei University College of Medicine , Seoul, Korea. 3. 3 Department of Ophthalmology, Ilsan Paik Hospital, Inje University College of Medicine , Goyang, Korea. 4. 4 Department of Ophthalmology, Chonnam National University Medical School and Hospital , Gwangju, Korea. 5. 5 Department of Ophthalmology, Seoul National University Bundang Hospital, Seoul National University College of Medicine , Seongnam, Korea. 6. 6 Department of Ophthalmology, Kangbuk Samsung Hospital, Sungkyunkwan University School of Medicine , Seoul, Korea.
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.
RCT Entities:
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.