NCT07412496尚未招募2 期
A Randomized, Vehicle-Controlled, Double-Masked, Parallel-Group Study to Evaluate the Use of Topical Ocular BL1332 for the Management of Postoperative Ocular Pain Following Photorefractive Keratectomy
干预措施
试验速览
- 阶段
- 2 期
- 状态
- 尚未招募
- 入组人数
- 123
- 主要终点
- Ocular pain intensity following PRK surgery
研究概览
简要总结
This is a multicenter, double-masked study to evaluate the use of Topical Ocular BL1332 for the management of post-operative pain after Photorefractive Keratectomy (PRK) surgery.
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
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 58 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male or female 18 to 58 years of age, inclusive.
- •Scheduled to undergo PRK surgery and considered to be a good candidate per the Investigator's discretion.
- •Provide written informed consent (signed and dated informed consent form [ICF]) using the Institutional Review Board (IRB)-approved ICF prior to any study-related procedures.
- •Able to read, understand, and voluntarily sign the ICF and, if applicable, provide written authorization per local privacy regulations.
排除标准
- •Participants who meet any of the following criteria will be excluded from this study. All criteria are evaluated at Screening unless otherwise specified.
- •Women of childbearing potential or non-vasectomized males with partners of childbearing potential are not eligible unless they are using an effective method of contraception and agree to use an effective method of contraception until at least 30 days after study treatment.
- •a. Male who is unwilling to agree to use at least 1 medically accepted form of birth control with female partner of childbearing potential.
- •Participation in a clinical trial within 30 days prior to Screening.
研究组 & 干预措施
Topical Ocular BL1332 low dose
Experimental
BL1332 low dose ocular drop used 5x daily
干预措施: Topical Ocular BL1332 low dose (Drug)
Topical Ocular BL1332 high dose
Experimental
BL1332 high dose ocular drop used 5x daily
干预措施: Topical Ocular BL1332 high dose (Drug)
BL1332 ophthalmic vehicle
Placebo Comparator
BL1332 vehicle ocular drop used 5x daily
干预措施: BL1332 Vehicle ophthalmic vehicle (Drug)
结局指标
主要结局
Ocular pain intensity following PRK surgery
时间窗: Assessed at a 24-hour period following PRK surgery
Ocular pain intensity assessed using numeric pain rating scale 0 to 10, with 10 being the worst pain
次要结局
- Ocular pain intensity postoperative period following PRK surgery(Assessed at a 12-hour postoperative period following PRK surgery)
研究者
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