A Multi-center, Randomized,Blinded Evaluator, Active Control, Parallel, Phase III Study to Evaluate the Efficacy and Safety of TJO-002 in Primary Open Angle Glaucoma or Ocular Hypertension Patients

TJO-002 or Acitve Control was administered on primary open-angle glaucoma or ocular hypertension patients for 12 weeks. This clinical trial study has hypothesize TJO-002 administration groups are not inferior to Active control administration groups.

开始日期2016-04-26

申办/合作机构

Taejoon Pharm Co. Ltd.

100 项与 TJO-002 相关的临床结果

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100 项与 TJO-002 相关的转化医学

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100 项与 TJO-002 相关的专利（医药）

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项与 TJO-002 相关的文献（医药）

2021-10-18·International Journal of Ophthalmology4区 · 医学

Efficacy and safety of newly developed preservative-free latanoprost 0.005% eye drops versus preserved latanoprost 0.005% in open angle glaucoma and ocular hypertension: 12-week results of a randomized, multicenter, controlled phase III trial

4区 · 医学

ArticleOA

作者: Kim, Chan Yun ; Rho, Seungsoo ; Kim, Joon Mo ; Kyung, Haksu ; Lee, Ji Woong ; Sung, Kyung Rim

AIM: To evaluate the therapeutic efficacy, safety and tolerability of newly developed preservative-free (PF) latanoprost generic [TJO-002] and compare it with benzalkonium chloride (BAK)-preserved latanoprost [Xalatan®] in patients with primary open angle glaucoma (POAG) and ocular hypertension (OHT). METHODS: Included patients were aged ≥19y with POAG/OHT. After a washout period, patients with IOP 21-35 mm Hg at 9 a.m. were enrolled. After a full ophthalmic and glaucoma examination, 144 patients with POAG and OHT participated in this study. Subjects were randomly assigned either PF latanoprost (74 eyes) or BAK-preserved latanoprost (70 eyes). All subjects were examined at 4, 8, and 12wk after first administration. At each follow-up visit, IOP was measured at 9 a.m. and 5 p.m. and compliance was assessed. Throughout the study, all adverse events were recorded and monitored by the masked investigators who measured IOP. RESULTS: Both groups showed a statistically significant decrease of average diurnal IOP at 12wk compared to baseline (-7.21±3.10 mm Hg in the PF latanoprost group and -7.02±3.17 mm Hg in the BAK latanoprost group, both P<0.0001). There was no statistically significant diurnal IOP variation between the groups. In terms of tolerability, pruritus, burning/stinging, and sticky eye sensation, severity was significantly lower in the PF latanoprost group than in the BAK latanoprost group (P<0.05). CONCLUSION: PF latanoprost has at least similar efficacy in terms of IOP reduction and better tolerability compared with BAK latanoprost.

100 项与 TJO-002 相关的药物交易

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研发状态

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适应症	最高研发状态	国家/地区	公司	日期
开角型青光眼	临床2期	韩国	Taejoon Pharm Co. Ltd.	2016-04-26

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研究	分期	人群特征	评价人数	分组	结果	评价	发布日期


Pubmed \| Int J Ophthalmol 人工标引	临床3期	开角型青光眼 \| 高眼压症	144	TJO-002	(鹽範鑰膚夢範願廠糧繭) = 壓齋積襯夢餘鬱顧遞製選壓築廠網糧鏇蓋獵構 (壓蓋醖選鹹積觸襯夢壓, 3.10)	相似	2021-10-18
				Xalatan	(鹽範鑰膚夢範願廠糧繭) = 齋膚壓窪憲鏇製餘憲繭選壓築廠網糧鏇蓋獵構 (壓蓋醖選鹹積觸襯夢壓, 3.17)