Skip to content

A Safety and Eye Irritation Assessment of the Test Product in Human Users.

A Study to Evaluate the In-Use Safety, Discomfort, and Eye Irritation Potential of Princess Kids Kajal in Human Subjects. - NIL

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2025/11/097843
Enrollment
20
Registered
2025-11-21
Start date
Unknown
Completion date
Unknown
Last updated
2025-12-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Interventions

Intervention1: Princess by Renee Magic Eyes Kajal: Mode of Usage: Apply at inner corner of the eye and gently glide the outward along the upper lid. Repeat the application to the lower lid, ensuring a

Sponsors

Renee Cosmetics Pvt. Ltd
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 1.Ages 6-12 years both inclusive. 2.Subjects are in general good health and has both eyes. 3.The child s mothers understand the test procedures and agree to adhere to study requirements, instructions and procedures. 4.The child passes an eye sting evaluation using isotonic saline. 5.Subject s mothers are willing to refrain from using any eye drops on the day of the study.

Exclusion criteria

Exclusion criteria: 1.Currently or within the last 2 weeks using eye drops (such as saline solutions, Netra-Prabha, Drasty, etc.). 2.Have participated in a study with the eyes as the target area within 6 weeks of the start of the study. 3.Be involved in any aspect of study administration, i.e., evaluating applying products, etc. 4.Have a history of sensitivity and/or adverse reactions to preparations intended for the eyes. 5.Subject currently having any eye infections or irritation. 6.The subject is having any sensitivity to eye make-up. 7.Currently have any eye infections or irritation including blepharitis, general lid inflammation, conjunctivitis, or an eye discharge within two weeks of the study. 8.Currently using any topical medications on the face or any medications intended for the eyes. 9.Have taken antihistamines (including those in cold tablets, OTC allergy medications, decongestants and inhalants) on the days of the study. 10.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. 11.Currently taking any prescription pain medications.

Design outcomes

Primary

MeasureTime frame
1.To assess the irritation and stinging/discomfort effect of the test product as compared to control with both subjective sting/irritation and objective evaluations. 2.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. 3.To evaluate the effectiveness of the test product in subject perception questionnaire.Timepoint: At Baseline Day 01 and Day 15.

Secondary

MeasureTime frame
NATimepoint: NA

Countries

India

Contacts

Public ContactMaheshvari Patel

NovoBliss Research Private Limited

dr.nayan@novobliss.in07948983895

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026