更新于：2024-12-06
Zhaoke Ophthalmology Ltd.
更新于：2024-12-06
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A Randomized, Open-label Phase I Clinical Study to Evaluate the Systemic Pharmacokinetics and Safety of Atropine Sulfate Eye Drops in Healthy Chinese Volunteers
A Phase 3, Multicenter, Randomized, Double-masked, Active Controlled Study to Evaluate the Efficacy and Safety of Epinastine Hydrochloride Eye Drops 0.05% in the Treatment of Chinese Seasonal Allergic Conjunctivitis Patients
0.05%盐酸依匹斯汀滴眼液用于治疗中国季节性过敏性结膜炎患者的有效性和安全性的多中心、随机、双盲、阳性对照III 期临床研究
100 项与 兆科眼科有限公司 相关的临床结果
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2024-11-01Dermatology and Therapy
Efficacy and Safety of a Fixed-Dose Combination Gel with Adapalene 0.1% and Clindamycin 1% for the Treatment of Acne Vulgaris (CACTUS): A Randomized, Controlled, Assessor-Blind, Phase III Clinical Trial
Article
作者: Deng, Lie Hua ; Gu, Heng ; Luan, Chao ; Han, Jian De ; Yang, Wen Lin ; Liu, Hong Wei ; Zhang, Shou Min ; Yin, Jia Wen ; Chen, Bin ; Chen, Kun ; Dai, Xiang Rong ; Yu, Xiao Hui ; Yin, Qiu Ju ; Li, Benjamin Xiao Yi ; Liu, Zhi Jun
BACKGROUND:
Combination therapy is required for the treatment of moderate acne vulgaris. However, patient compliance in applying multiple topical formulations is poor.
OBJECTIVE:
To assess the efficacy and safety of a fixed-dose combination gel with adapalene 0.1% and clindamycin 1% (adapalene-clindamycin) relative to adapalene 0.1% monotherapy and clindamycin 1% monotherapy in patients with moderate facial acne vulgaris.
METHODS:
This was a randomized, controlled, assessor-blind, phase III study conducted in patients with moderate facial acne vulgaris.
RESULTS:
A total of 1617 patients were enrolled. At week 12, patients in the adapalene-clindamycin gel treatment group showed a significant reduction in the percentage change from baseline in total lesion count (- 66.85%), compared with adapalene alone (- 50.82%) or clindamycin gel alone (- 57.61%). The difference in the least square means of the adapalene-clindamycin gel group and adapalene group, or clindamycin gel group was - 16.08% (95% CI - 19.95% to - 12.21%) and - 9.38% (95% CI - 13.25% to - 5.51%;), respectively. At week 12, 19.28% of participants who received adapalene-clindamycin gel achieved at least 2-grade improvement in IGA, versus 7.74% with adapalene gel (OR 3.05, 95% CI 1.93, 4.80) and 14.77% with clindamycin gel (OR 1.42, 95% CI 0.97, 2.07). The study also achieved all its secondary endpoints. Adverse event rates were mostly mild to moderate and comparable across the three treatment groups.
CONCLUSION:
Adapalene 0.1%-clindamycin 1% combination gel is well tolerated and demonstrated superior efficacy over 0.1% adapalene gel monotherapy and 1% clindamycin gel monotherapy for the treatment of moderate acne vulgaris.
TRIAL REGISTRATION:
ClinicalTrials.gov identifier NCT03615768.
2023-01-01Molecular vision
Therapeutic effects of a novel venom abstract (ZK002) solution in an alkali-burned corneal wound-healing model.
Article
作者: Peng, Wen-Yan ; Sun, Qin-Yan ; Jiang, Zheng-Xuan ; Yang, Shuang-Jian ; Zhou, Heng-Shen ; Zhou, Shi-You ; Wang, Fei ; Li, Xiaoyi
Purpose:
Corneal alkali burns can progress to corneal epithelial defects, inflammation, scarring, and angiogenesis, potentially leading to blindness. Therefore, we examined the therapeutic effects of a novel ophthalmic solution (ZK002) on wound healing in alkali-burned rat corneas.
Methods:
In this study, we attempted to treat alkali-exposed rat corneas using topical application of either an ophthalmic solution with ZK002 or an anti-vascular endothelial growth factor agent for 14 days. We evaluated corneal edema, corneal neovascularization area, and histological changes. We also assessed the inflammatory (MMP-9, MMP-2, and interleukin-1β) and angiogenic (vascular endothelial growth factor receptor 2, VEGFR2) markers. Levels of inflammatory (matrix metalloproteinase (MMP)-9, MMP-2, and interleukin-1β), profibrotic (α-smooth muscle actin, α-SMA; transforming growth factor-β2,TGF-β2), and angiogenic (vascular endothelial growth factor-receptor 2, VEGFR2) factors, as well as peroxisome proliferator-activated receptor γ (PPARγ) mRNA expression, were measured.
Results:
The analyses showed that alkali exposure caused an increase in corneal edema and fibrosis with corneal neovascularization. The accumulation of α-smooth muscle actin-positive myofibroblasts and the deposition of transforming growth factor-β2 on the alkali-exposed corneas were noted on day 14. The mRNA expression levels of interleukin-1β, MMP-9, MMP-2, VEGFR2, and profibrotic factors were decreased in the ZK002 group compared with the control group during the early period of corneal alkali burns on day 14. However, the expression level of PPARγ mRNA was increased in the ZK002 group.
Conclusions:
ZK002 decreased the fibrotic reaction and prevented neovascularization in the cornea after an alkali burn. Therefore, the novel ophthalmic solution ZK002 could be a potentially promising therapeutic clinical treatment for corneal wound healing.
2022-07-04Seminars in ophthalmology4区 · 医学
Germinal peptide eye drop promotes corneal epithelial and stromal defect healing in rabbit model
4区 · 医学
Article
作者: Zhou, Lijia ; Pan, Zhiqiang ; Guan, Jieying ; Li, Xiaoyi ; Wang, Li
OBJECTIVE:
Corneal defect is a common disease in ophthalmology caused by trauma, inflammation, drug toxicity, or surgery. To investigate the effect of germinal peptide eye drop on corneal epithelial and stromal defects after lamellar keratectomy in rabbit model.
METHODS:
Eighty-five male New Zealand white rabbits were divided into five groups: Germinal Peptide eye drop at three different concentration groups, normal saline (negative control group), recombinant human epidermal growth factor (rh-EGF) eye drop (positive control group). Corneal epithelial and stromal defects of around 150-200 μm in depth were created with an 8 mm diameter trephine in the center of the right eyes of all animals.
RESULTS:
Germinal peptide eye drop with the concentration of 0.001%, 0.002%, and 0.004% and rh-EGF eye drop were more effective in promoting healing, reducing opacity, and edema during the process of corneal epithelial and stromal defect regeneration compared with 0.9% normal saline. No significant difference was observed among the three different doses of germinal peptide eye drop. Compared with the saline control group, the structures of the regenerated corneas were more orderly and less inflammatory cell infiltration was observed in the germinal peptide eye drop groups and the rh-EGF eye drop group.
CONCLUSION:
Germinal peptide eye drop (0.001%, 0.002%, and 0.004%) can significantly stimulate the regeneration of corneal epithelia and stroma and reduce corneal opacity and edema. Dose dependency was not observed in the current study.
100 项与 兆科眼科有限公司 相关的药物交易
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100 项与 兆科眼科有限公司 相关的转化医学
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