NCT07354516已完成2 期
A Masked, Randomized, Prospective Study of QLS-111-FDC in Subjects With Open-Angle Glaucoma or Ocular Hypertension
干预措施
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 64
- 试验地点
- 1
- 主要终点
- Change from baseline in IOP
研究概览
简要总结
Firecrest study is evaluating the intraocular pressure (IOP)-lowering effect, safety, and tolerability of Qlaris' preservative free [PF], fixed-dose combination [FDC] investigational product (IP) in subjects with open-angle glaucoma (OAG) or ocular hypertension (OHT).
详细描述
14-day prospective, double-masked, active-controlled, randomized multicenter study comparing QLS-111-FDC and PF latanoprost. Study is comprised of 5 visits.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
盲法说明
IP is packaged and labeled in a masked fashion
入排标准
- 年龄范围
- 12 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •BCVA 1.0 logMAR or better in each eye (equivalent to 20/200)
- •Diagnosis of mild to moderate OAG or OHT in at least one eye
- •IOP ≥19 mmHg at 08:00 hour (H) at Qualification Visits following a run-in with PF latanoprost
排除标准
- •History of active ocular disease other than mild to moderate OAG/OHT
- •Prior use of any topical PGA without a clinically meaningful response
- •Noncompliant with current ocular anti-hypertensive medications or unwilling to be compliant throughout the study
- •Use of other topical ocular concomitant medications 30 days prior
- •History of angle closure or a narrow angle, significant ocular trauma, ocular infection, uveitis, intraocular surgery in either eye.
- •Central corneal thickness in either eye <470 or >630 μm
- •Clinically significant systemic or psychiatric disease, chronic kidney disease, or hypertension, hypotension, or diabetes that is uncontrolled.
- •Participation in any investigational study within 30 days prior to Screening
- •Females who are pregnant, nursing, or not using birth control.
研究组 & 干预措施
QLS-111-FDC ophthalmic solution
Experimental
QLS-111-FDC, PF FDC
干预措施: QLS-111-FDC (Combination Product)
Latanoprost ophthalmic solution
Active Comparator
PF latanoprost 0.005%
干预措施: Latanoprost (0.005%) (Drug)
结局指标
主要结局
Change from baseline in IOP
时间窗: Over 15 days
Change from baseline in IOP, lowering of IOP compared to baseline is desirable outcome.
次要结局
- Ocular safety and tolerability(Over 15 days)
- Ocular comfort(Over 15 days)
研究者
研究点 (1)
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