A Multi-Center, Randomized, Double Masked, Placebo Controlled Clinical Study to Assess the Efficacy and Safety of TOP1630 0.1% Ophthalmic Solution Compared to Placebo in Subjects With Moderate to Severe Dry Eye Syndrome

In subjects with Dry Eye Syndrome (DES):
The primary objective of this study is to confirm the efficacy of TOP1630 0.1% Ophthalmic Solution TID OU compared to placebo treatment at Day 29 on pre-specified sign and symptom endpoints in subjects with moderate to severe DES.

开始日期2019-02-13

申办/合作机构

Topivert Pharma Ltd.

NCT03088605 / Completed临床2期

A Single-Center, Randomized, Double Masked, Placebo Controlled Clinical Study to Assess the Safety and Efficacy of TOP1630 Ophthalmic Solution Compared to Placebo in Subjects With Dry Eye Syndrome

In subjects with Dry Eye Syndrome:
The primary objective of this study is to compare the safety and tolerability of TOP1630 Ophthalmic Solution to placebo.
The secondary objectives are to compare the efficacy of TOP1630 Ophthalmic Solution to placebo for the treatment of the signs and symptoms of dry eye syndrome.

开始日期2017-02-20

申办/合作机构

北京橙鑫数据科技有限公司

[+1]

100 项与 TOP-1630 相关的临床结果

登录后查看更多信息

100 项与 TOP-1630 相关的转化医学

登录后查看更多信息

100 项与 TOP-1630 相关的专利（医药）

登录后查看更多信息

项与 TOP-1630 相关的文献（医药）

Clinical Ophthalmology

<p>A phase 2 randomized, double-masked, placebo-controlled study of novel nonsystemic kinase inhibitor TOP1630 for the treatment of dry eye disease</p>

Article

作者: Webber, Steve ; Walshe, Claire ; Torkildsen, Gail ; Ousler, George ; Fyfe, Matthew C T ; Taylor, Mike ; Rowley, Adele ; Sheppard, John D ; Duggal, Ajay

PURPOSETo evaluate the safety and efficacy of topical TOP1630, a novel nonsystemic kinase inhibitor, in dry eye disease (DED).PATIENTS AND METHODSA randomized, double-masked, parallel-group trial of 0.1% TOP1630 ophthalmic solution TID or placebo (vehicle without active drug) was conducted in DED subjects (n=61). Key eligibility criteria consistent with enrolling a moderate to severe DED population included >6 months DED history; OSDI^© score ≥18; Schirmer's test score ≤10 and ≥1 mm/5 minutes; tear film break-up time >1 and <7 seconds; and dry eye exacerbation in corneal staining and ocular discomfort in a Controlled Adverse Environment (CAE^®). After a 7-day run-in period with placebo TID, eligible subjects were randomized to TOP1630 or placebo for 28 days. No supplemental artificial tears or rescue medication were allowed.RESULTSTOP1630 was safe, well-tolerated, and efficacious in treating DED symptoms and signs. No serious adverse events (AEs) or withdrawals due to treatment emergent AEs occurred. Drop comfort scores showed TOP1630 to be comfortable and comparable with placebo. Significant symptom improvements were seen for TOP1630 vs placebo for ocular discomfort (P=0.02 post-CAE), grittiness/foreign body sensation (on four independent assessment scales, each P<0.05), worst DED symptom (diary, P=0.06), and ocular pain (VAS, P=0.03). Sign improvements were seen for total ocular surface (all regions), corneal sum, and conjunctival sum staining with TOP1630 compared with placebo (each P<0.05).CONCLUSIONTOP1630 had placebo-like tolerability and produced improvements in multiple symptom and sign endpoints in both environmental and challenge settings. The emergent TOP1630 benefit-risk profile for DED treatment is highly favorable and supports further development.

100 项与 TOP-1630 相关的药物交易

登录后查看更多信息

研发状态

10 条进展最快的记录,

后查看更多信息

适应症	最高研发状态	国家/地区	公司	日期
干眼症	临床3期	-	TopiVert Ltd.	-
干眼综合征	临床1期	美国	TopiVert Ltd.	2019-02-13
干眼综合征	临床1期	美国	Topivert Pharma Ltd.	2019-02-13

登录后查看更多信息

临床结果

适应症

分期

评价

查看全部结果

研究	分期	人群特征	评价人数	分组	结果	评价	发布日期


NCT03088605 (CTgov)	临床2期	干眼综合征	69	TOP1630 Ophthalmic Solution (Active)	願蓋積淵壓鬱鹹築淵淵(膚繭繭餘鹽衊鹽觸齋襯) = 醖鹹蓋鹹構製蓋築糧構醖襯製遞夢艱醖鏇鏇壓 (齋選積憲糧鬱選選鑰網, 蓋窪憲鹹顧構鹹願網糧 ~ 選遞鹽遞範獵網鑰衊醖) 更多	-	2024-02-14
				Placebo to TOP1630 Ophthalmic Solution (Placebo)	願蓋積淵壓鬱鹹築淵淵(膚繭繭餘鹽衊鹽觸齋襯) = 壓夢構觸網艱蓋鹽構鏇醖襯製遞夢艱醖鏇鏇壓 (齋選積憲糧鬱選選鑰網, 範夢鑰願夢網獵鬱顧憲 ~ 壓鹹築繭廠鹹遞鹹廠齋) 更多
NCT03088605 (Pubmed) 人工标引	临床2期	干眼综合征	61	TOP1630	(鹹廠選糧獵願衊膚選鬱): P-Value = <0.05 更多	积极	2019-02-12
				Placebo