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To test the cosmetic safety by assessing the eye irritation and also to assess the no eye tears in healthy male and female human volunteers.

A clinical study to assess the comparative eye irritation potential of Yellow Hippo Tear free Shampoo & Body wash marketed by Vishal Mega Mart Pvt. Ltd. using Human eye direct instillation method in 12 healthy adult male and female volunteers.

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2022/01/039626
Enrollment
12
Registered
2022-01-21
Start date
Unknown
Completion date
Unknown
Last updated
2022-10-17

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

Conditions

None listed

Interventions

Intervention1: Yellow Hippo Tear free Shampoo & Body wash: 0.1 mL of 10% wt/vl (10% solid mass to liquid volume) will be instilled in the inferior cul de sac while the lower eyelid will be retracted d

Sponsors

Vishal Mega Mart Pvt Ltd
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 1. No medical condition of the eye as determined by the subjects medical history. 2. Subjects not under doctors care for ocular or periorbital diseases 3. The subject will refrain from using contact lenses, any topical facial products, any eye drops, false eyelashes, make up, over the counter products, or cosmetics on their eyes, eyelids, eyelashes, or the periorbital areas of the face during the study 4. Subject is willing to provide the informed consent 5. Subject having not participated in a similar investigation in the past one month. 6. Subjects ready to follow instructions during the study period.

Exclusion criteria

Exclusion criteria: 1. Conjunctival corneal conditions and periocular area conditions, 2. Use of contact lenses, 3. Pregnancy/lactation, and other diseases or medications that may directly interfere in the study or endanger the subjectââ?¬•s health.

Design outcomes

Primary

MeasureTime frame
Objective Ophthalmic Scoring Scale (Slit Lamp Biomicroscope Examination) 1) Lacrimation 2) Eyelid Irritation 3) Palpebral Conjunctival Irritation 4) Bulbar Conjunctival Irritation using 5) Corneal Abnormalities (opacities, edema, infiltrates, vascularization, and/or epithelial defects) using 0-4 scaleTimepoint: Up to 120 min

Secondary

MeasureTime frame
Subjective Opthalmic scoring scale (Irritation scoring- Stinging, Burning, Itching, dryness and or foreign body sensationTimepoint: Up to 120 min;To assess the adverse eventsTimepoint: 7 days

Countries

India

Contacts

Public ContactDr Anand Sachdeva

Trinetraalaya Eye Care & Surgical Center

drmanjunathmn@yahoo.com

Outcome results

None listed

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