Injecting a substance drop by drop in to Eye to know tear developing ability
- Registration Number
- CTRI/2020/07/026411
- Lead Sponsor
- Azafran Innovacion ltd
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 25
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.
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.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 1.To assess the irritation and stinging/discomfort effect of test product as compared to control with both subjective sting/irritation and objective evaluations. <br/ ><br>2.To assess the visual effect i.e. degree of inflammation of bulbar conjunctiva, palpebral conjunctiva, lacrimation of test product as compared with the control. <br/ ><br>3.To measure reproducibility of both the subjective scores and objective evaluations by Ophthalmologist. <br/ ><br>Timepoint: 1.After Product Instillation on Day 01 <br/ ><br>2.After Product Instillation on Day 01 <br/ ><br>3.After Product Instillation on Day 01 <br/ ><br>
- Secondary Outcome Measures
Name Time Method ot ApplicableTimepoint: Not Applicable