CTRI/2025/05/086765尚未招募不适用
Evaluation and Comparing the Perceived Discomfort and/or Eye Sting Potential of Test Products in Adult Human Subjects
Maxima Solutions1 个研究点 分布在 1 个国家目标入组 32 人开始时间: 2025年5月23日最近更新:
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 32
- 试验地点
- 1
- 主要终点
- 2.To assess the visual effect i.e., degree of inflammation of bulbar conjunctiva, palpebral conjunctiva, and lacrimation of test product as compared with the control.
研究概览
简要总结
Evaluationand Comparing the Perceived Discomfort and/or Eye Sting Potential of TestProducts in Adult Human Subjects
A total of 32subjects will be enrolled to complete 30 subjects the study.
Visit 01 (Day 01) Screening, Enrolment,Baseline Assessment
Visit 02 (Day 02) Test Product Usageperiod, end of study
研究设计
- 研究类型
- Observational
入排标准
- 年龄范围
- 18.00 Year(s) 至 65.00 Year(s)（—）
- 性别
- Female
入选标准
- •Age: 18-65 years (both inclusive) at the time of consent.
- •Sex: Males and non-pregnant/non-lactating females 3)Females with self-reported negative pregnancy test.
- •The study Participant is in general good health and has both eyes.
- •Understand the test procedures and agree to adhere to study requirements, instructions and procedures.
- •Pass a general eye evaluation as assessed by trained clinicians/ophthalmologists.
- •Have visual acuity of at least 20/40, (with corrective wear, i.e. glasses but not contact lens during the study) 8)Pass an eye sting evaluation using isotonic saline.
- •Pass an ophthalmologist eye evaluation as assessed by a consulting ophthalmologist.
- •Study participants are willing to refrain from using any eye drops on the day of the study.
排除标准
- •Currently or within the last 2 weeks using eye drops (such as saline solutions, Netra-Prabha, Drasty, etc).
- •Have worn contact lenses during the study period.
- •Have any of the following conditions or factors that may affect the interpretation of the test results, including but not limited to, diabetes (controlled or uncontrolled), currently pregnant, or currently lactating or have lactated within the last 4 months.
- •Have participated in a study with the eyes as the target area within 6 weeks of the start of the study.
- •Be involved in any aspect of study administration, i.e., evaluating applying products, etc.
- •Have a history of sensitivity and/or adverse reactions to preparations intended for the eyes.
- •Ever had any eye conditions such as glaucoma, cataracts, exophthalmos (protuberance of the eye), etc.
- •Subject currently having any eye infections or irritation.
- •The subject is having any sensitivity to eye make-up.
- •Currently have any eye infections or irritation including blepharitis, general lid inflammation, conjunctivitis, or an eye discharge within two weeks of the study.
- •Ever had any eye surgery (including Lasik, laser eye surgery).
- •Currently have any allergies or chronic allergies or sensitivities to soaps, shampoos, conditioners, or any other hair products such as detangles as well as fragrances.
- •Currently using any topical medications on the face or any medications intended for the eyes.
- •Be wearing any facial makeup, including false eyelashes, on the day of the study visits.
- •Consume any alcoholic beverages during the days of the study.
- •Have taken antihistamines (including those in cold tablets, OTC allergy medications, decongestants and inhalants) or analgesics (including aspirin or other over-the-counter analgesics) on the days of the study.
- •Have any other condition or factor that the Investigator or Ophthalmologist believes may affect the stinging or tearing response or the interpretation of the results.
- •Currently taking any prescription pain medications.
- •Have smoked within 1 hour before each study visit or during the study visit.
结局指标
主要结局
2.To assess the visual effect i.e., degree of inflammation of bulbar conjunctiva, palpebral conjunctiva, and lacrimation of test product as compared with the control.
时间窗: Day 01 | Day 15
1.To assess the irritation and stinging/discomfort effect of the test product as compared to control with both subjective sting/irritation and objective evaluations.
时间窗: Day 01 | Day 15
3.To evaluate the effectiveness of the test product in subject perception questionnaire
时间窗: Day 01 | Day 15
次要结局
未报告次要终点
研究者
研究点 (1)
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