To determine the ocular irritation potential of the test product by direct eye-instillation technique

Not Applicable

Completed

• Registration Number: CTRI/2023/10/059290
• Lead Sponsor: prising Science Pvt. Ltd.

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Completion: 2023-12-07
• Last Update Posted: 22 January 2024

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 36

Inclusion Criteria

1. Healthy adult non-pregnant/non-lactating females with age 18 to 65 years (both inclusive) at the time of consent.

2. Subjects in general good health as determined by the Investigator on the basis of medical history and with no medical conditions of the eye.

3. Subjects who pass a general eye examination as assessed by Ophthalmologist.

4. Subjects who pass an eye sting evaluation using isotonic saline and an Ophthalmologist Eye evaluation as assessed by Ophthalmologist.

5. Subjects having visual acuity of at least 20/40 (with corrective wear, i.e., glasses but not contact lens).

Exclusion Criteria

1. Subjects wearing any facial and eye makeup including false eye lashes on the day of the study visits.

2. Subjects currently using or have used eye drops (e.g., Visine, Saline Solutions, etc.) within the last 2 weeks.

3. Subjects who ever had any eye conditions such glaucoma, cataracts, exophthalmos (protuberance of eye), etc.

4. Subjects having any eye infections or irritation including blepharitis, general lid inflammation, conjunctivitis, or an eye discharge within 2 weeks of the study.

5. Subjects who had any eye surgery (including Lasik, laser eye surgery).

6. Subjects having any other condition or factor that the Investigator or Ophthalmologist believes may affect the stinging or tearing response or the interpretation of the results.

Study & Design

• Study Type: Interventional
• Study Design: Not specified