PMID- 31374063
OWN - NLM
STAT- MEDLINE
DCOM- 20190812
LR  - 20221005
IS  - 1536-5964 (Electronic)
IS  - 0025-7974 (Print)
IS  - 0025-7974 (Linking)
VI  - 98
IP  - 31
DP  - 2019 Aug
TI  - Efficacy and safety of 0.05% cyclosporine ophthalmic emulsion in treatment of 
      Chinese patients with moderate to severe dry eye disease: A 12-week, multicenter, 
      randomized, double-masked, placebo-controlled phase III clinical study.
PG  - e16710
LID - 10.1097/MD.0000000000016710 [doi]
LID - e16710
AB  - BACKGROUND: Dry eye disease (DED) is a chronic ocular surface disease that 
      affects hundreds of millions of people worldwide. Although 0.05% cyclosporine 
      ophthalmic emulsion (CsA OE) has long been prescribed in the U.S. for the 
      treatment of DED, it is not commercially available in China. Our study aims to 
      compare the efficacy and safety profile of 0.05% CsA OE versus vehicle in Chinese 
      patients with moderate to severe DED. METHODS: This was a multicenter, 
      randomized, double-masked, 2-parallel-arm, 3-month phase III study. Patients with 
      moderate to severe DED were randomized to receive twice-daily 0.05% CsA OE or its 
      vehicle, along with unpreserved hypromellose eye drops 3 times per day. Patients 
      were followed up at day 7, 28, 56, and 84, as well as 2 weeks after the 
      medications were discontinued for safety assessment. RESULTS: A total of 240 
      patients were randomized. The overall effective rate (OER) and efficacy index 
      were significantly better in the CsA OE than vehicle group at all follow up times 
      (all P < .05), and the OER of CsA OE and vehicle group at month 3 was 70.6% and 
      27.8%, respectively (P < .001) (primary endpoint). The patients in CsA OE group 
      displayed a significant improvement in dry eye symptoms from day 28 and ocular 
      surface test results from day 7 (all P < .05). The ocular surface disease index 
      scores of 0.05% CsA OE treated patients were significantly better than those 
      treated with vehicle control at day 56 and 84 (P = .0061 and <.001, 
      respectively). Drug related adverse events (AEs) were recorded in 6(5%) and 
      3(2.5%) patients in the CsA OE and vehicle groups respectively (P = .4061) with 
      ocular pain as the most frequently reported AEs, and it was mostly mild to 
      moderate. There were no detrimental effects on visual acuity, intraocular 
      pressure, or vital signs. CONCLUSIONS: Twice-daily instillation of 0.05% CsA OE 
      was effective and well tolerated for the treatment of moderate to severe DED in 
      Chinese population during the 3 months of the study.
FAU - Chen, Di
AU  - Chen D
AD  - Department of Ophthalmology, Peking Union Medical College Hospital, Chinese 
      Academy of Medical Sciences & Peking Union Medical College.
FAU - Zhang, Shunhua
AU  - Zhang S
AD  - Department of Ophthalmology, Peking Union Medical College Hospital, Chinese 
      Academy of Medical Sciences & Peking Union Medical College.
FAU - Bian, Ailing
AU  - Bian A
AD  - Department of Ophthalmology, Peking Union Medical College Hospital, Chinese 
      Academy of Medical Sciences & Peking Union Medical College.
FAU - Hong, Jing
AU  - Hong J
AD  - Department of Ophthalmology, Peking University Third Hospital, Beijing.
FAU - Deng, Yingping
AU  - Deng Y
AD  - Department of Ophthalmology, West China Hospital, Sichuan University, Chengdu.
FAU - Zhang, Mingchang
AU  - Zhang M
AD  - Department of Ophthalmology, Union Hospital, Tongji Medical College, Huazhong 
      University of Science and Technology, Wuhan.
FAU - Chen, Wei
AU  - Chen W
AD  - School of Ophthalmology and Optometry and Eye Hospital, Wenzhou Medical 
      University, Zhejiang.
FAU - Shao, Yan
AU  - Shao Y
AD  - Department of Ophthalmology, Second Affiliated Hospital of Dalian Medical 
      College, Dalian, China.
FAU - Zhao, Jialiang
AU  - Zhao J
AD  - Department of Ophthalmology, Peking Union Medical College Hospital, Chinese 
      Academy of Medical Sciences & Peking Union Medical College.
LA  - eng
PT  - Clinical Trial, Phase III
PT  - Journal Article
PT  - Multicenter Study
PT  - Randomized Controlled Trial
PL  - United States
TA  - Medicine (Baltimore)
JT  - Medicine
JID - 2985248R
RN  - 0 (Ophthalmic Solutions)
RN  - 83HN0GTJ6D (Cyclosporine)
SB  - IM
MH  - Adult
MH  - China
MH  - Cyclosporine/*administration & dosage
MH  - Double-Blind Method
MH  - Dry Eye Syndromes/*drug therapy
MH  - Female
MH  - Humans
MH  - Male
MH  - Middle Aged
MH  - Ophthalmic Solutions/*administration & dosage
MH  - Severity of Illness Index
MH  - Treatment Outcome
PMC - PMC6709181
COIS- The authors have no conflicts of interest to disclose.
EDAT- 2019/08/03 06:00
MHDA- 2019/08/14 06:00
PMCR- 2019/08/02
CRDT- 2019/08/03 06:00
PHST- 2019/08/03 06:00 [entrez]
PHST- 2019/08/03 06:00 [pubmed]
PHST- 2019/08/14 06:00 [medline]
PHST- 2019/08/02 00:00 [pmc-release]
AID - 00005792-201908020-00061 [pii]
AID - MD-D-19-01942 [pii]
AID - 10.1097/MD.0000000000016710 [doi]
PST - ppublish
SO  - Medicine (Baltimore). 2019 Aug;98(31):e16710. doi: 10.1097/MD.0000000000016710.