Evaluation of the Perceived Discomfort and/or Eye Irritation Potential of Test Product in Adult Human Subjects
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 10
- 试验地点
- 1
- 主要终点
- 1.To assess the irritation and stinging/discomfort effect of the test product as comparedto control with both subjective sting/irritation and objective evaluations.
研究概览
简要总结
The subject will take a test product on their fingertip and then gently massage of the test product onto the eye area (with the eye closed) for 30 seconds to simulate the removal of the eye-make up, dirt, sweat etc. The subject will then be asked to open their eyes and to rate the intensity of perceived discomfort/irritation using the Stinging/Discomfort Scale. This score will be recorded on the Test product Evaluation form. The subject will then be asked to rinse the eye with 6 handfuls of water (which takes about 10 seconds), re-open the eye, and rate the intensity of discomfort/stinging after rinsing. The subject will be instructed to continue rinsing the eye using the same procedure (6 handfuls of water) until the stinging score reaches 0. The water should be running the entire time during this procedure for emergency situations. If more than one sink is used, ensure that the water pressure is consistent in all sinks. After rinsing each eye, the subjects may gently pat dry each eye, but may not rub the eye to avoid any irritation. Any remaining eyeliner can be removed after the subject sees the ophthalmologist for the final evaluation. Once the washing procedure has been completed, the subject will return to the ophthalmologist-trained evaluator | optometrist within 5 minutes after completing the wash procedure
研究设计
- 研究类型
- Interventional
- 分配方式
- Other
- 盲法
- None
入排标准
- 年龄范围
- 18.00 Year(s) 至 45.00 Year(s)（—）
- 性别
- All
入选标准
- •1.Participant is in general good health and has both eyes.
- •2.Understand the test procedures and agree to adhere to study requirements, instructions and procedures.
- •3.Males and Females (non-pregnant/non-lactating).
- •4.Ages 18-45 years both inclusive.
- •5.Females who wears eye makeup.
- •6.The study general eye evaluation as assessed by trained clinicians.
- •7.Pass an eye sting evaluation using isotonic saline.
- •8.Study participants are willing to refrain from using any eye drops on the day of the study.
排除标准
- •1.Currently or within the last 2 weeks using eye drops (such as saline solutions, Netra-Prabha, Drasty, etc).
- •2.Have worn contact lenses during the study period.
- •3.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.
- •4.Have participated in a study with the eyes as the target area within 6 weeks of the start of the study.
- •6.Be involved in any aspect of study administration, i.e., evaluating applying products, etc.
- •7.Have a history of sensitivity and/or adverse reactions to preparations intended for the eyes.
- •8.Ever had any eye conditions such as glaucoma, cataracts, exophthalmos (protuberance of the eye), etc.
- •9.Subject currently having any eye infections or irritation.
- •10.The subject is having any sensitivity to eye make-up.
- •11.Currently have any eye infections or irritation including blepharitis, general lid inflammation, conjunctivitis, or an eye discharge within two weeks of the study.
- •12.Ever had any eye surgery (including Lasik, laser eye surgery).
- •13.Currently using any topical medications on the face or any medications intended for the eyes.
- •14.Consume any alcoholic beverages during the days of the study.
- •15.Have taken antihistamines (including those in cold tablets, OTC allergy medications, decongestants and inhalants) or analgesics (including aspirin or other over-the-couter analgesics) on the days of the study.
- •16.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.
- •17.Currently taking any prescription pain medications.
- •18.Have smoked within 1 hour before each study visit or during the study visit.
结局指标
主要结局
1.To assess the irritation and stinging/discomfort effect of the test product as comparedto control with both subjective sting/irritation and objective evaluations.
时间窗: Day 01, 07 and 15
2.To assess the visual effect i.e., degree of inflammation of bulbar conjunctiva, palpebralconjunctiva, and lacrimation of test product as compared with the control.
时间窗: Day 01, 07 and 15
3.To evaluate the effectiveness of the test product in subject perception questionnaire
时间窗: Day 01, 07 and 15
次要结局
未报告次要终点
研究者
Dr Nayan Patel
NovoBliss Research Private Limited