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A study to evaluate ocular irritation of test product on human subjects

Evaluation of the Perceived Discomfort and/or Eye Irritation Potential of Test Product in Adult Human Subjects - NIL

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2025/09/095395
Enrollment
10
Registered
2025-09-24
Start date
Unknown
Completion date
Unknown
Last updated
2025-10-13

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

Conditions

None listed

Interventions

Intervention1: Minimalist Marula Oil 05% Cleansing Oil: Mode of Usage: Take required quantity of product on fingertips and massage gently on face to remove make-up and dirt Frequency: Once a Day Route

Sponsors

Uprising Science Pvt. Ltd
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 1.Participant is in general good health and has both eyes. 2.Understand the test procedures and agree to adhere to study requirements, instructions and procedures. 3.Males and Females (non-pregnant/non-lactating). 4.Ages 18-45 years both inclusive. 5.Females who wears eye makeup. 6.The study general eye evaluation as assessed by trained clinicians. 7.Pass an eye sting evaluation using isotonic saline. 8.Study participants 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 worn contact lenses during the study period. (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 within 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 using any topical medications on the face or any medications intended for the eyes. 14.Consume any alcoholic beverages during the days of the study. 15.Have taken antihistamines (including those in cold tablets, OTC allergy medications, decongestants and inhalants) or analgesics (including aspirin or other over-the-couter analgesics) on the days of the study. 16.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. 17.Currently taking any prescription pain medications. 18.Have smoked within 1 hour before each study visit or during the study visit

Design outcomes

Primary

MeasureTime frame
1.To assess the irritation and stinging/discomfort effect of the test product as comparedto control with both subjective sting/irritation and objective evaluations. 2.To assess the visual effect i.e., degree of inflammation of bulbar conjunctiva, palpebralconjunctiva, and lacrimation of test product as compared with the control. 3.To evaluate the effectiveness of the test product in subject perception questionnaireTimepoint: Day 01, 07 and 15

Secondary

MeasureTime frame
NILTimepoint: NIL

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