Phase I Clinical Study, to Evaluate the Safety and Tolerability of the Ophthalmic Solution PRO-185 When 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
- 22
- 试验地点
- 1
- 主要终点
- Intraocular Pressure (IOP) Increment
研究概览
简要总结
Phase I Study to evaluate safety and tolerability of PRO-185 (naphazoline/hypromellose) ophthalmic solution through evaluation of vital signs, ocular signs such as intraocular pressure, hyperemia and mydriasis and adverse events.
详细描述
A total of 22 healthy volunteers will apply PRO-185 ocular solution on both eyes QID (four times per day) for 8 days. The safety variables will include intraocular pressure, heart rate, systolic and diastolic blood pressure. Tolerability variables will include: hyperemia, mydriasis, and expected and unexpected adverse events. The presence of any of these in ≤ 20% will deem PRO-185 as safe and 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 45 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Being clinically healthy
- •Having the ability to grant a signed informed consent
- •Being able and willing to comply with the programmed visits, treatment plan and other procedures of this study.
- •Age between 18 and 45 years
- •Women in child-bearing age must assure the continuation (start ≥ 30 days previous to the signing of the ICF) of a hormonal contraceptive method or a intrauterine device (IUD) during the period of the study.
- •Best corrected visual acuity equal of better than 20/30 in both eyes.
- •Vital signs within normal ranges.
- •Intraocular pressure ≥10 and ≤ 21 mmHg
排除标准
- •Using any kind of topic ophthalmic products
- •Presenting allergies to naphazoline or the history of intolerance to nasal decongestants or ocular vasoconstrictive products.
- •History of diagnosis of suspicion of primary angle closure, primary angle closure or closed angle glaucoma.
- •History of iridotomies or waiting for this procedure to take place.
- •Conjunctival hyperemia grade 3 or 4 according to Efron scale.
- •Ocular surface staining equal or greater to 3 in the SICCA scale, for any eye.
- •Using medications or herbology products, through any route of administration.
- •Pregnant, breastfeeding or women who plan to get pregnant during the period of the study.
- •Previous participation in any clinical study 90 days prior to the inclusion in the present study.
- •Previous participation in this study.
- •Using contact lenses which cannot be suspended during the period of this study.
- •History of any chronic illness, including diabetes and hypertension.
- •Active inflammation or infection at the time of inclusion in this study.
- •Unresolved lesions or traumas at the moment of inclusion in this study.
- •History of any kind of ocular surgery.
- •History of any surgical procedure, non-ophthalmologic, within the previous 3 months to the inclusion in this study.
研究组 & 干预措施
PRO-185
Healthy volunteers will apply one drop of PRO-185 ophthalmic solution (naphazoline / hypromellose) on both eyes, QID (four times per day) for 8 days.
干预措施: Naphazoline / Hypromellose Ophthalmic (Drug)
结局指标
主要结局
Intraocular Pressure (IOP) Increment
时间窗: Baseline visit (BV), day 1(pre and post pupil dilation); Visit 1 (V1), day 3 +1 (pre and post research product application); Visit 2 (V2), day 8 (pre and post research product application); Final Visit, day 10 (+1)
Safety evaluation through the incidence of subjects presenting an IOP elevation comparing Baseline Visit, Final Visit and before and after (20 minutes) research product administration (V1 and V2). Only right-eye values were analyzed.
Heart Rate Increment
时间窗: Baseline visit, day 1(pre and post pupil dilation); Visit 1, day 3 +1 (pre and post research product application); Visit 2, day 8 (pre and post research product application); Final Visit, day 10 (+1)
Safety evaluation through the incidence of subjects presenting an elevation \> 15 beats per minute 20 minutes after administration, in comparison to baseline value.
Blood Pressure Increment (Systolic)
时间窗: Baseline visit, day 1(pre and post pupil dilation); Visit 1, day 3 +1 (pre and post research product application); Visit 2, day 8 (pre and post research product application); Final Visit, day 10 (+1)
Safety evaluation through the incidence of subjects presenting an elevation \> 15 mmHg in systolic pressure or \> 10 mmHg in diastolic pressure 20 minutes after administration, in comparison to baseline value.
Incidence of Conjunctival Hyperemia
时间窗: Trough Day 10 (+1)
Tolerability evaluation through the incidence of conjunctival hyperemia grades 3 and 4 (according to the Efron scale). A higher score (grades) in this scale translates into worse outcomes. Only right-eye values were analyzed.
Incidence of Pharmacological Mydriasis
时间窗: Trough Day 10 (+1)
Incidence of pharmacological mydriasis measured through OPD III scan. If there was a change greater than 2 mm in pupil diameter between the baseline visit and any of the other measurements, pharmacological mydriasis was considered present, also if there was this change between the pre- and post-examination of the investigational product during visits 1 and 2.
Blood Pressure Increment (Diastolic)
时间窗: Baseline visit, day 1(pre and post pupil dilation); Visit 1, day 3 +1 (pre and post research product application); Visit 2, day 8 (pre and post research product application); Final Visit, day 10 (+1)
Safety evaluation through the incidence of subjects presenting an elevation \> 15 mmHg in systolic pressure or \> 10 mmHg in diastolic pressure 20 minutes after administration, in comparison to baseline value.
次要结局
未报告次要终点