Eye Stinging Potential of Fame labs Soothe Stick

A Single Blind Clinical Study to evaluate the Eye Stinging Potential of Fame labs Soothe Stick Varient: Soothe No Colour End And Black End on healthy human volunteers - NIL

Status

Active, not recruiting

Phases

Phase 4

Study type

Observational

Source

CTRI

Registry ID

CTRI/2025/10/096414

Enrollment

Registered

2025-10-23

Start date

Unknown

Completion date

Unknown

Last updated

2025-11-17

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

Conditions

None listed

Interventions

Intervention1: Test Product: 1. SOOTHE STICK VARIENT: DEFINE (BLACK END) BRAND- TRUTH BE TOLD 2. SOOTHE STICK VARIENT: SOOTHE (NO COLOUR END) BRAND- TRUTH BE TOLD: Route of Administration: Topical D

Eligibility

Inclusion criteria

Inclusion criteria: 1.Healthy males or females, 18 to 60 years with no medical conditions of the eyes as determined by the subjects medical history and confirmed by an ophthalmologist 2. Subjects not under any doctor care for ocular or peri orbital 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.

Exclusion criteria

Exclusion criteria: 1.Subjects who are pregnant, breast-feeding, or planning to become pregnant during the study. 2.Have any evidence of systemic cancer, squamous cell carcinoma, basal cell carcinoma, in the last 5 years, or any other confounding skin condition. 3.Have any condition that, in the opinion of the investigator, would confound the safety and/or efficacy assessments of the product. 4.Have participated in any interventional clinical trial in the previous 30 days. 5.Have a known sensitivity to any of the constituents of the test product including sensitivities to cocoamidopropyl betaine, coumarin, Aloe barbadensis etc. 6.Have used, are using, or are planning to use immunosuppressive or immunomodulatory medication (i.e., biologics), including corticosteroids. 7.Have a history of alcohol or illegal drug/substance abuse, or suspected alcohol or illegal drug/substance abuse in the past 2 years.

Design outcomes

Primary

Measure	Time frame
1. Change in Discomfort 2. Change in Lacrimation 3. Change in Conjunctival inflammation 4. Change in Cornea and iris inflammationTimepoint: Time Points 0-1 days	—

Secondary

Measure	Time frame
Not ApplicableTimepoint: Not Applicable	—

Countries

India

Contacts

Public ContactPuneet Mittal

CCFT Laboratories

puneetmittal@mgcts.org08937015757

Outcome results