Phase I Clinical Trial to Evaluate the Safety and Tolerability of the Ophthalmic Solution PRO-230 When Applied to the Ocular Surface of Healthy Volunteers.
试验速览
- 阶段
- 1 期
- 状态
- 撤回
- 主要终点
- Incidence of unexpected adverse events
研究概览
简要总结
Phase I Study to evaluate safety and tolerability of PRO-230 (atropine sulphate 0.05%) ophthalmic solution through evaluation of incidence of non-expected adverse events (AE), photophobia, pupillary diameter, incidence of expected adverse events, and best near corrected visual acuity (BNCVA)
详细描述
A total of 29 healthy volunteers will apply PRO-230 ocular solution on both eyes QD (one time per day) for 14 days. The safety variables will include non expected AE, pupillary diameter and expected AE; tolerability variables will include incidence of photofobia, and BNCVA. Exploratory variables include best corrected visual acuity (BCVA), intraocular pressure (IOP), corneal an conjunctival staining with fluorescein and lissamine green, vital signs (heart rate and blood pressure), and results of the Ocular Confort Index (OCI) questionnaire.
The presence of non-expected AE < 10% will deem PRO-230 as safe; while an incidence of photophobia < 30% will deem PRO-230 as tolerable.
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.
- •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.
研究组 & 干预措施
PRO-230
Healthy volunteers will apply one drop of PRO-230 ophthalmic solution (atropine sulphate) on both eyes, QD (one time per day) for 14 days.
干预措施: Atropine Sulfate (Drug)
结局指标
主要结局
Incidence 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.
Incidence of photophobia
时间窗: Through Day 21 ± 1 (Safety Call)
The number of cases of photophobia.
次要结局
- Incidence of expected adverse events(Through Day 21 ± 1 (Safety Call))
- Pupillary Diameter(Days: 1 (Basal Visit), 7 ± 1 (Visit 1), 16 ± 1 (Final Visit)])
- Measurement of the change in best near corrected visual acuity (BNCVA)(Time Frame: Days: 1 (Basal Visit), 7 ± 1 (Visit 1), 16 ± 1 (Final Visit))