Eye Sting Test and Human Eye Irritation Study
- Registration Number
- CTRI/2022/07/044272
- Lead Sponsor
- Ginni Filaments Limited
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 40
1)Age: 18-65 years (both inclusive) at the time of consent.
2)Sex: Males and non-pregnant/non-lactating females (preferably an equal number of males and females).
3) The study Participant is in general good health and has both eyes.
4) Understand the test procedures and agree to adhere to study requirements, instructions and procedures.
5) Pass a general eye evaluation as assessed by trained clinicians/ophthalmologists.
6)� Have visual acuity of at least 20/40, (with corrective wear, i.e. glasses but not contact lens)
7)� Pass an eye sting evaluation using isotonic saline, and
8)� Pass an ophthalmologist eye evaluation as assessed by a consulting ophthalmologist.
9)� Study participants are willing to refrain from using any eye drops on the day of the study.
1)� Currently or within the last 2 weeks using eye drops (such as saline solutions, Netra-Prabha, Drasty, etc).
2) Have ever worn contact lenses for the year (12 months).
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 with in 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.
5) Be participating in any other study concurrently.
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 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.
15)Be wearing any facial makeup, including false eyelashes, on the day of the study visits.
16)Consume any alcoholic beverages during the days of the study.
17)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.
18)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.
19)Currently taking any prescription pain medications
20) Have smoked within 1 hour before each study visit or during the study visit
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method To assess the irritation and stinging/discomfort effect of the test product as compared to control with both subjective sting/irritation and objective evaluations. <br/ ><br> <br/ ><br>Timepoint: 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).
- Secondary Outcome Measures
Name Time Method To assess the visual effect i.e. degree of inflammation of bulbar conjunctiva, palpebral conjunctiva, and lacrimation of test product as compared with the controlTimepoint: 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).;To measure the reproducibility of both the subjective scores and objective evaluations by ophthalmologistsTimepoint: Before and After dosing of solutions