NCT06375343尚未招募1 期
Phase I Clinical Study to Evaluate the Safety and Tolerability of PRO-240 Ophthalmic Solution Compared to Optive® on the Ocular Surface of Ophthalmologically and Clinically Healthy Volunteers
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 尚未招募
- 入组人数
- 32
- 主要终点
- Incidence of unexpected adverse events related to the interventions
研究概览
简要总结
This is a phase I clinical study to evaluating safety and tolerability of PRO-240 ophthalmic solution through the incidence of unexpected adverse events, as well as through changes in Best Corrected Visual Acuity (BCVA), and the incidence of stinging after its administration, compared to Optive®.
详细描述
The variables to be evaluated include:
Primary (safety):
- Incidence of unexpected advere events (AE's)
Secondary:
- Changes in the ocular comfort index (OCI) score
- Changes in intraocular pressure (IOP)
- Changes in Best Corrected Visual Acuity (BCVA)
- Adherence to treatment
- Changes in tear film breakup time
- Changes in 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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
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.
- •Ophthalmologically and clinically healthy subjects.
- •Being able to and willing to comply with scheduled visits, treatment plan, and other study procedures.
- •Age ≥18 years.
- •Male or female gender.
- •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 informed consent form [ICF]) of the use of a hormonal contraceptive method or intrauterine device (IUD) during the study period.
- •Best corrected visual acuity (BCVA) of 20/30 or better in both eyes.
- •Corneal staining ≤ grade I on the Oxford Scale.
- •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.
- •Use of non-steroidal anti-inflammatory drugs, steroid anti-inflammatory drugs, or antibiotics by any route of administration in the last 30 days.
- •History of eye surgery in the last 6 months.
- •Use of contact lenses for a period less than two weeks prior to the start of the study, and during the intervention period of this study.
- •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.
- •Active smoking (specified as the consumption of cigarettes regardless of the amount and frequency, 4 weeks prior to study inclusion and during the intervention period of this study).
- •Active alcoholism (specified as the consumption of alcoholic beverages, regardless of the amount and frequency, 72 hours prior to study inclusion and during the intervention period of 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
PRO-240
Experimental
- Propylene glycol 0.3% - Polyethylene glycol 400 0.5% - Glycerin 0.2%. Ophthalmic solution.
- Dosage: 1 drop QID [4] (four times per day) for 7 days in both eyes.
- Route of administration: Ophthalmic
干预措施: PRO-240 (Drug)
Optive®
Active Comparator
- Carboxymethylcellulose 0.5%; Glycerin 0.9%. Ophthalmic solution.
- Dosage: 1 drop QID [4] (four times per day) for 7 days in both eyes.
- Route of administration: Ophthalmic
干预措施: Optive® (Drug)
结局指标
主要结局
Incidence of unexpected adverse events related to the interventions
时间窗: Days 0: (Basal Visit), 8 (Final Visit) and 11 (Safety Call)
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 integrity of the ocular surface (fluorescein staining)(Days: 0 (Basal Visit) and 8 (Final Visit))
- Adherence to treatment (adherence) Adherence to treatment (adherence)(Days: 8 (Final Visit))
- Changes in intraocular pressure (IOP)(Days: 0 (Basal Visit) and 8 (Final Visit))
- Changes in Best Corrected Visual Acuity (BCVA)(Days: 0 (Basal Visit) and 8 (Final Visit))
- Changes in the Ocular Comfort Index score(Days: 0 (Basal Visit), and 8 (Final Visit))
- Changes in tear film breakup time(Days: 0 (Basal Visit) and 8 (Final Visit))
- Changes in lissamine green staining of the conjunctival surface(Days: 0 (Basal Visit) and 8 (Final Visit))
研究者
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