ACTRN12618000033246已完成1 期
A double-blind, placebo-controlled, randomised trial to determine the ocular pharmacokinetics and safety of oral FT011 in patients with glaucoma.
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 8
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomised controlled trial
- 主要目的
- Treatment
入排标准
- 年龄范围
- 18 Years 至 o limit（—）
- 性别
- All
入选标准
- •Male or female, aged at least 18 years.
- •- Have confirmed glaucoma.
- •- Are scheduled to have trabeculectomy, tube surgery, or other glaucoma surgery, performed at the study site.
- •- Agree to practice effective contraception (as outlined in the protocol) during the study period.
- •- Provide written informed consent
排除标准
- •- pregnant or breastfeeding, or plan to become pregnant during the study
- •- Have received any investigational drug within 5 half-lives or the 2 months prior to Screening (4 months if the previous drug was a new chemical entity), whichever is longer.
- •- Have only one eye
- •- Have active uveitis.
- •- Have clinically significant ocular conditions other than glaucoma.
- •- Have had ocular surgery in the 6 months prior to screening.
- •- Have a known allergy to the investigational medicinal product (IMP).
- •- Have any other medical condition or significant co-morbidities, or any finding during Screening, which may interfere with the study objectives in the investigator’s opinion.
- •Have a history of or current clinically relevant social, clinical, or psychiatric condition which, in the opinion of the investigator, makes the participant unsuitable for participation in the study.
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