CTRI/2026/04/107440尚未招募不适用
Assessment of Ophthalmologic Safety and Tolerability of Baby Products in Adults
Mother Sparsh Baby Care Pvt. Ltd.1 个研究点 分布在 1 个国家目标入组 36 人开始时间: 2026年4月7日
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 36
- 试验地点
- 1
研究概览
简要总结
This study evaluates the ocular safety and tolerability of the randomized test products. Eligible subjects will be enrolled after consent and medical history review. On visit 1, a single instillation of the diluted test product will be administered in one eye and distilled water in the other eye. Ocular irritation and reaction will be performed at specified time points up to 24 hours. After washout period, the procedure will be repeated for subsequent products. Subjects will attend the scheduled visits and remain at the study site as required for assessments.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- Participant and Investigator Blinded
入排标准
- 年龄范围
- 18.00 Year(s) 至 60.00 Year(s)（—）
- 性别
- All
入选标准
- •1.Subjects with no medical conditions of the eye as determined by the subjects medical history and confirmed by the ophthalmologist.
- •Subjects not under any doctors care for or peri orbital diseases.
- •Subjects willing to refrain from using any topical facial products, any eye drops, false eyelashes, make-up, over the counter products, or cosmetics on their eyes, eyelids, eyelashes, or the periorbital areas of the face during the study.4.Subjects in good health and willing to provide written informed consent and attend regular follow-up visits.5.Subjects willing to comply with the study protocol and refrain from participating in any other clinical study during the current study.
排除标准
- •1.Subject with conjunctival, corneal, or periocular conditions, or those using contact lenses.
- •2.Subject with known history or present allergic condition that may require medical attention.
- •3.Subject with chronic illness which may influence the cutaneous assessment.
- •4.Subjects on any systemic medication or with birth defect and anomalies.
- •5.Subjects with a past or present history of significant ophthalmological disease or conditions, or those judged by the investigator to be inappropriate for this trial.
研究者
Dr Manjula Y M
BGS Global Institute of Medical Sciences
研究点 (1)
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