Phase I Clinical Study to Evaluate the Safety and Tolerability of PRO-190 Ophthalmic Solution Compared to Systane Ultra® on the Ocular Surface of Ophthalmologically and Clinically Healthy Volunteers.
试验速览
- 阶段
- 1 期
- 状态
- 尚未招募
- 入组人数
- 32
- 主要终点
- Incidence Unexpected Related Adverse Reactions
研究概览
简要总结
This is a phase I clinical study to evaluate the safety and tolerability of PRO-190 ophthalmic solution through the incidence of unexpected adverse events, changes in Best Corrected Visual Acuity (BCVA), changes in ocular surface integrity, changes in the ocular comfort index (OCI) score, and IOP measurement compared to Systane Ultra®.
详细描述
The variables to be evaluated include:
Primary (safety):
Incidence Unexpected Related Adverse Reactions
Secondary:
Changes in the ocular comfort index (OCI) score in between interventions Changes in Best Corrected Visual Acuity (BCVA) Changes in tear film breakup time Changes in intraocular pressure (IOP) Changes in the integrity of the ocular surface (fluorescein staining) Changes in lissamine green staining
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Outcomes Assessor)
盲法说明
Single-blind
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Having the ability to voluntarily give their signed informed consent.
- •Clinically healthy subjects.
- •Being able to and willing to comply with scheduled visits, treatment plan, and other study procedures.
- •Age ≥ 18 years.
- •No history of contact lens wear
- •Women of childbearing potential who have not undergone Bilateral Tubal Occlusion (BTO [Tubal Ligation]), hysterectomy, or bilateral oophorectomy must ensure continuation (initiated ≥ 30 days prior to signing the ied consent form [ICF]) of the use of a hormonal contraceptive method or intrauterine device (IUD) during the study period.
- •Having vital signs within normal parameters.
- •Best corrected visual acuity (BCVA) of 20/30 or better in both eyes.
- •Having an intraocular pressure ≥ 10 and ≤ 21 mmHg.
排除标准
- •History of hypersensitivity to any of the components of the drugs under investigation.
- •Use of ophthalmic medications from any pharmacological group.
- •Use of medications by any other route of administration.
- •In the case of women: being pregnant, breastfeeding, or planning to become pregnant within the study period.
- •Having participated in any clinical research study 30 days prior to inclusion in this study.
- •Having previously participated in this same study.
- •History of any chronic-degenerative disease, including Diabetes Mellitus or Systemic Arterial Hypertension.
- •Diagnosis of glaucoma or ocular hypertension.
- •Known diagnosis of liver or heart disease.
- •Presenting active inflammatory or infectious disease at the time of entry into the study.
- •Presenting unresolved lesions or traumas at the time of entry into the study.
- •Having been subjected to non-ophthalmological surgical procedures in the last 3 months.
- •Being or having an immediate family member (e.g., spouse, parent/legal guardian, sibling, or child) who is an employee of the research site or the sponsor, and who directly participates in this study.
- •Elimination Criteria
- •Withdrawal of their consent to participate in the study (informed consent form).
- •Occurrence of a serious adverse event, whether related or not to the interventions, that in the opinion of the principal investigator (PI) and/or the sponsor, could affect the patient's fitness to safely continue with the study procedures.
- •Non-tolerability or hypersensitivity to any of the compounds used during the tests -(fluorescein, tetracaine).
- •Non-tolerability or hypersensitivity to any of the drugs under investigation.
- •Adherence < 80% determined by the subject's diary and corroborated by the final weight of the research products (RP) compared to the initial weight.
研究组 & 干预措施
Systane Ultra®
Propylene glycol 0.3% - Polyethylene glycol 400 0.4%. Ophthalmic solution.
Dosage: 1 drop QID [4] (4 times per day, at least three hours apart between doses) for 7 days in both eyes,
Route of administration: Ophthalmic.
干预措施: Systane Ultra® (Drug)
PRO-190
Propylene glycol 0.3% - Polyethylene glycol 400 0.3%. Ophthalmic solution.
Dosage: 1 drop QID [4] (4 times per day, at least three hours apart between doses) for 7 days in both eyes,
Route of administration: Ophthalmic.
干预措施: PRO-190 (Drug)
结局指标
主要结局
Incidence Unexpected Related Adverse Reactions
时间窗: Through study completion, an average of 12 days. Evaluations will take place on days 0 (Basal Visit), 8 (Final Visit) and 12 (Safety Call) after the inclusion of each subject.
Any unfavorable medical condition affecting the subject after the administration of the investigation product, related to such intervention.
次要结局
- Changes in the ocular comfort index (OCI) score in between interventions(Through study completion, an average of 12 days. Evaluations will take place on days 0 (Basal Visit), and 8 (Final Visit) after the inclusion of each subject.)
- Changes in lissamine green staining(Through study completion, an average of 12 days. Evaluations will take place on days 0 (Basal Visit), and 8 (Final Visit) after the inclusion of each subject.)
- Changes in intraocular pressure (IOP)(Through study completion, an average of 12 days. Evaluations will take place on days 0 (Basal Visit), and 8 (Final Visit) after the inclusion of each subject.)
- Changes in Best Corrected Visual Acuity (BCVA)(Through study completion, an average of 12 days. Evaluations will take place on days 0 (Basal Visit), and 8 (Final Visit) after the inclusion of each subject.)
- Changes in tear film breakup time(Through study completion, an average of 12 days. Evaluations will take place on days 0 (Basal Visit), and 8 (Final Visit) after the inclusion of each subject.)
- Changes in the integrity of the ocular surface (fluorescein staining)(Through study completion, an average of 12 days. Evaluations will take place on days 0 (Basal Visit), and 8 (Final Visit) after the inclusion of each subject.)