CTRI/2020/07/026411已完成未知
A Human Ocular Instillation study
Azafran Innovacion ltd0 个研究点目标入组 25 人开始时间: 待定最近更新:
试验速览
- 阶段
- 未知
- 状态
- 已完成
- 发起方
- 入组人数
- 25
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
入选标准
- •1)Age: - 18 to 65 years (both inclusive) at the time of consent.
- •2)Sex: Healthy male and non-pregnant, non-lactating Females.
- •3)Does not wear contact lens or is willing to refrain from wearing lens for at least a 24-hour period before dosing and for 1 hour after the final examination.
- •4)Willing to refrain from using any eye drops and applying cosmetics (e.g. mascaras, shadows, eye liners, false eyelashes, creams and moisturizers) around the eye the day of the study.
- •5)Study participant is in general good health and have both eyes.
- •6)Understand the test procedures and agree to adhere to study requirements, instructions and procedures.
- •7)Pass a general eye evaluation as assessed by trained Ophthalmologist.
- •8)An adult subjects must have visual acuity of at least 20/40, (with corrective wear, i.e. glasses but not contact lens).
- •9)Pass an eye sting evaluation using isotonic saline.
排除标准
- •10)Have current participation on any other study with the eyes as the target area within 2 weeks of the start of the study and/or participating in any other study concurrently.
- •11)Consumption of alcoholic beverages the day of the study.
- •12)Participation in a study involving the eye area within the last 4 weeks.
- •13)Allergies to cosmetic/personal care product(s) ingredients or who have developed positive patch test responses to ingredients of cosmetics/personal care products.
- •14)Currently pregnant or lactating.
- •15)Have symptoms of infection of the eye including blepharitis, general lid inflammation, conjunctivitis, or an eye discharge within two weeks of the study.
- •16)Has a history of dry eye (kerato conjunctivitis sicca) or glaucoma.
- •17)Currently taking any prescription anti-inflammatory drugs, using eye drops (prescription or OTC), and/or is currently taking any prescription drug known to have ocular effects.
- •18)Has 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 day of the study.
- •19)Has conjunctival hyperemia, conjunctivitis, any pathologic condition of the eye including cataracts, scars or evidence of abrasion of the surface of the eye at the initial slit lamp evaluation conducted by the Ophthalmologist.
- •20)Ever had any eye surgery (including Lasik, laser eye surgery).
- •21)Has any other condition or factor the Investigator or Ophthalmologist believes may affect the stinging or tearing response or the interpretation of the test results.
- •22)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.
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