Phase I Clinical Study to Evaluate the Safety and Tolerability of PRO-201 Ophthalmic Solution Applied on the Ocular Surface of Healthy Volunteers.
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 29
- 试验地点
- 1
- 主要终点
- Number of Unexpected Adverse Events
研究概览
简要总结
Evaluation of the safety and tolerability of PRO-201 (0.01% sulfate atropine) after its instillation on the ocular surface of healthy volunteers through the following variables: unexpected adverse events incidence and photophobia (primary outcome variables); as well as pupillary diameter, expected adverse events incidence, best near corrected visual acuity (BNCVA), best corrected visual acuity (BCVA), intraocular pressure (IOP), corneal and conjunctival staining, heart rate, blood pressure and ocular confort index (OCI),
详细描述
A total of 29 healthy volunteers will be enrolled in this study. They will receive one drop of the investigation product PRO-201 (0.01% atropine sulfate) once a day (QD) for a total of 14 days on both eyes. A final safety call will be performed one week after the last day of product application.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 35 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Being clinically healthy
- •Ability to voluntarily sign an informed consent form (ICF).
- •Ability and willingness to comply with the scheduled visits according to the intervention plan and other procedures of the study.
- •Age between 18 and
- •Absence of history of contact lens use.
- •Women of childbearing age must agree to continue (starting ≥ 30 days previous to the ICF) the use of a hormonal contraception method of a intrauterine device (IUD) during the period of the study.
- •Best corrected visual acuity (BVCA) of at least 20/30 (logMAR 0.2) or better in both eyes.
- •Best near corrected visual acuity (BNVCA) of at least 20/25 (logMAR 0.1) or better in both eyes.
- •Presenting vital signs within normal parameters.
- •Presenting an IOP ≥10 and ≤ 21 mmHg
排除标准
- •Using any kind of ophthalmic topical products.
- •Presenting known allergy or intolerance to any ingrediente of atropine eyedrops or any other derivatives of antimuscarinic agents.
- •Using any medication of herbolary products (plant extracts, infusions, naturist preparations, homeopathy, etc) through any route of administration
- •For women: being pregnant, breastfeeding or planning to get pregnant during the period of the study.
- •Having participated in any clinical study 90 days prior to the inclusion in this study.
- •Having participated in this clinical study.
- •Inability to follow the lifestyle considerations of this study.
- •History of any chronic degenerative disease, including diabetes and hypertension.
- •Presenting active inflammatory or infectious diseases when entering this study.
- •Presenting unresolved lesions or trauma when entering this study.
- •History of any ocular surgery.
- •History of any surgery, non-ocular, within the previous 3 months of entering this studies.
- •Being or having an direct family member (spouse, parent/legal guardian, sibling, etc) as employee of the investigation site or the sponsor, who participates directly in this study.
- •Elimination criteria:
- •Withdraw of ICF.
- •Adverse event, related or not to the investigation product, that according to the principal investigator and/or the sponsor may affect the integrity of the patient to continue safely with the study's procedures.
- •Hypersensitivity or lack of tolerance to any of the ingredients used during the study's procedures (fluorescein, lissamine green, tetracaine, etc)
- •Hypersensitivity or lack of tolerance to the investigation product.
- •Presenting an adherence to treatment < 90%, as determined through the subjects diary.
研究组 & 干预措施
PRO-201
A total of 29 anticipated healthy volunteers will be exposed to the investigation product.
干预措施: Atropine Sulfate (Drug)
结局指标
主要结局
Number of Unexpected Adverse Events
时间窗: Through Day 21 ± 1 (Safety Call)
The number of adverse events presented that are not previously described / known for the active substance in this pharmaceutic form and concentration.
Number of Patients With Photophobia
时间窗: Days: 1 (Basal Visit), 7 ± 1 (Visit 1), 16 ± 1 (Final Visit)
The number of cases of photophobia.
次要结局
- Pupillary Diameter(Days: 1 (Basal Visit), 7 ± 1 (Visit 1), 16 ± 1 (Final Visit))
- Percentage of Expected Adverse Events(Days: 1 (Basal Visit), 7 ± 1 (Visit 1), 16 ± 1 (Final Visit), 21 ± 1 (Safety Call))
- Measurement of the Change in Best Near Corrected Visual Acuity (BCNVA)(Days: 1 (Basal Visit), 7 ± 1 (Visit 1), 16 ± 1 (Final Visit))