JPRN-jRCT2031210588
已完成
1 期
A randomized, participant- and investigator-masked, vehicle-controlled study to assess the safety, tolerability and pharmacokinetics of topical ocular SAF312 in Japanese healthy participants
Hiroyuki Yamada0 个研究点目标入组 36 人2022年1月28日
概览
- 阶段
- 1 期
- 干预措施
- 未指定
- 疾病 / 适应症
- 未指定
- 发起方
- Hiroyuki Yamada
- 入组人数
- 36
- 状态
- 已完成
- 最后更新
- 2年前
概览
简要总结
In conclusion, topical ocular SAF312 was well tolerated with no ocular and systemic safety and tolerability concerns. Increase in dose from 0.5% to 1.5% resulted dose-proportional increase in systemic exposure, with low systemic exposure of one eye drop SAF312 1.5% 4 times daily for 7 days in healthy Japanese participants.
研究者
入排标准
入选标准
- •Written informed consent must be obtained before any assessment is performed
- •\- Japanese healthy male and female participants of age 20 to 45 years (inclusive), and in good health as determined by past medical history, physical examination, vital signs, electrocardiogram(ECG), and laboratory tests at screening
- •\- At screening, participants must weigh at least 50 kg to participate in the study, and must have a body mass index (BMI) within the range of 18 \- 30 kg/m2\. BMI \= Body weight(kg) / \[Height (m)]2
- •\- At screening, vital signs (body temperature, systolic and diastolic blood pressure(BP) and pulse rate) will be assessed in the sitting position. Sitting vital signs should be within the following ranges:
- •\- body temperature between 35\.0\-37\.5 degree Celsius
- •\- systolic BP, 90\-139 mmHg
- •\- diastolic BP, 50\-89 mmHg
- •\- pulse rate, 40\-90 bpm
- •If vital signs are outside these ranges, the Investigator may obtain two additional readings, so that up to three consecutive assessments are made. At least the last reading must be within the ranges provided above in order for the participant to qualify.
- •\- Able to communicate well with the investigator, to understand and comply with the requirements of the study
排除标准
- •\- Participants demonstrating any medical condition (systemic or ophthalmic) that may, in the opinion of the investigator, and based on the content of the Investigator's Brochure(IB), preclude the safe administration of test article or safe participation in this study
- •\- History of any ocular surgery or laser within the past 6 months prior to screening
- •\- History of any chronic eye disease other than refractive error, incipient cataract, strabismic amblyopia, or anisometropic amblyopia
- •\- Participants with a history of acute eye disease (such as infection, corneal abrasion, or allergy) within the past 6 months from screening may be eligible if the disease is not currently active
- •\- Any currently active ocular condition that requires use of topical eye drops
- •\- Participants using CPAP or other sleep apnea devices
- •\- Part 3 (esthesiometry) only, participants who have used contact lenses in the past 3 years or currently, in order to minimize variability in cornea sensitivity because of contact lens use
结局指标
主要结局
未指定
相似试验
已完成
2 期
Study of SAF312 as an Eye Drop for Treatment of Eye Pain Following Photorefractive Keratectomy (PRK) SurgeryPostoperative Ocular Pain After PRK SurgeryNCT02961062Novartis Pharmaceuticals40
已完成
不适用
Safety and Efficacy of 2 Concentrations of Lubricin vs Sodium Hyaluronate in Ocular Discomfort After Refractive Surgery.Ocular DiscomfortNCT03031327Dompé Farmaceutici S.p.A30
已完成
3 期
An Investigation of FID 123320 for the Reduction of Ocular Redness in Pediatric and Adult PopulationsOcular RednessEye IrritationNCT06538662Alcon Research283
已完成
2 期
A Study That Tests BI 1467335 in Patients With Diabetic Eye Disease (Diabetic Retinopathy). It Looks at the Way BI 1467335 is Taken up, the Effects it Has, and How Well it is Tolerated.Diabetic RetinopathyNCT03238963Boehringer Ingelheim79
已完成
2 期
Nebivolol 0.5, 1.0, or Timolol 0.5 Suspension Compared to Timolol 0.5 Solution to Treat Glaucoma/Ocular HypertensionOpen-Angle GlaucomaOcular HypertensionNCT04910100Betaliq, Inc.226