Evaluation and Comparing the Perceived Discomfort and/or Eye Sting Potential of Test Products in Adult Human Subjects
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- To assess the irritation and stinging/discomfort effect of the test product as compared to control with both subjective sting/irritation and objective evaluations.
研究概览
简要总结
Upon qualification for the study, subjects will participate in the eye sting evaluation of the test product. Each qualified subject will receive one product and the other is distilled water.
After the Ophthalmologist completes his/her initial examination, if the subject qualifies for the study, they will be instructed to sit in an examination chair in a partially reclined position. A study staff member will place his/her thumb or finger on the skin beneath the lower lashes and the adjacent finger on the skin of the upper eyelid and gently spread the lids apart to display the lower conjunctival sac.
Ten microliters (10µl) of the 10% solution of the test product in distilled water (weigh/weigh) or distilled water based on the study randomization will be placed into the conjunctival sac of the right eye. The staff member will instruct the subject to close her/his eye for a few seconds as he/she removes his/her hand. Once applied, the subject will then rate the stinging of the eye on a 0-3 scale (approximately 30 seconds after application).
This dosing procedure will be repeated in the left eye with distilled water (based on the randomization) and scored again on a 0-3 scale approximately 30 seconds after instillation for self-perceived discomfort. Once a product has been applied to both eyes, the Ophthalmologist will evaluate the eye area using the scales listed above. These assessments (both Ophthalmologist and self-perceived eye discomfort) will be made approximately at 30 seconds (immediate), 15 minutes, and again at approximately 1 hour (60 minutes) after the dosing solutions have been instilled into the eye(s).
The Ophthalmologist will also make his/her assessments on a 0-3 scale using a Slit-lamp for evaluations of lacrimation and redness of the bulbar and palpebral conjunctiva.
If a subject rates their eye discomfort at a 2 or 3 at the 60-minute time-point, they will be asked to rinse their eyes (both) with marketed eye wash solution and asked to remain at the test facility for another 15 minutes, at which time the subject will be asked a second time about any eye discomfort. If the subject still reports eye discomfort of a 2 or 3 they will be asked to rinse their eyes (both) a second time with the marketed eye wash solution. The subject will have a final evaluation by the study Ophthalmologist at which time the study Ophthalmologist will determine if it is safe for the subject to leave the facility.
研究设计
- 研究类型
- Interventional
- 分配方式
- Computer generated randomization
- 盲法
- Participant and Outcome Assessor Blinded
入排标准
- 年龄范围
- 18.00 Year(s) 至 65.00 Year(s)（—）
- 性别
- All
入选标准
- •Age: 18-65 years (both inclusive) at the time of consent.
- •Sex: Males and non-pregnant/non-lactating females (preferably an equal number of males and females).
- •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.
- •Â Have visual acuity of at least 20/40, (with corrective wear, i.e. glasses but not contact lens) 7)Â Pass an eye sting evaluation using isotonic saline, and 8)Â Pass an ophthalmologist eye evaluation as assessed by a consulting ophthalmologist.
- •Â Study participants are willing to refrain from using any eye drops on the day of the study.
排除标准
- •Â Currently or within the last 2 weeks using eye drops (such as saline solutions, Netra-Prabha, Drasty, etc).
- •Have ever worn contact lenses for the year (12 months).
- •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 with in 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 participating in any other study concurrently.
- •Be involved in any aspect of study administration, i.e., evaluating applying products, etc.
- •Â 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 12)Ever had any eye surgery (including Lasik, laser eye surgery) 13)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 14)Currently using any topical medications on the face or any medications intended for the eyes.
- •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 20) Have smoked within 1 hour before each study visit or during the study visit.
结局指标
主要结局
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: Approximately at 30 seconds (immediate), 15 minutes, and again at approximately 1 hour (60 minutes) after the dosing solutions have been instilled into the eye(s).
次要结局
- To measure the reproducibility of both the subjective scores and objective evaluations by ophthalmologists(Before and After dosing of solutions)
- 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(Approximately at 30 seconds (immediate), 15 minutes, and again at approximately 1 hour (60 minutes) after the dosing solutions have been instilled into the eye(s).)