Eye Stinging Potential of Silphion S-Face Wash E

Not Applicable

Not yet recruiting

Conditions: Not Applicable

Registration Number: CTRI/2025/05/086297

Lead Sponsor: Silphion Research Private Limited

Brief Summary: single arm clinical study.

5 Î¼L of the appropriate test should be instilled into the lower conjunctival sac of one eye, and another eye should be instilled with Normal Saline as Negative control. No Positive control to be taken.

Assessment would be done as 5-point scale for the below attributes after 1 min/2 min/5 min.

1.

Subjective discomfort,

Score 0: No discomfort felt Score 1: Faint, barely perceptible discomfort Score 2: Mild, low intensity discomfort that does not prevent the subject from opening lids Score 3: Moderately intense discomfort that interferes with but does not prevent lid opening Score 4: Severe, very intense discomfort that makes voluntary lid opening difficult, requires force to pull lids apart, and results in the subject requesting washout of test article

2.

Objective lacrimation,

Score 0: No tearing or lid wetness above normal Score 1: Noticeable increase in moistness of lid edges - no frank tearing Score 2: Frank tearing - meager flow Score 3: Frank tearing - moderate flow Score 4: Frank tearing - copious flow

3. Objective conjunctival inflammation,

Score 0: Inflammatory changes absent Score 1: Capillaries slightly more prominent than they were at time of baseline examination Score 2: Capillaries very prominent plus some diffuse conjunctival reddening Score 3: Vessels very prominent plus diffuse and confluent intense redness Score 4: Beefy redness and everted lids

4. Objective cornea and iris inflammation

Score 0: No effect detected with use of slit lamp Score 1: Barely perceptible clouding or pitting of cornea or thickening of iris detected via slit lamp Score 2: Faint clouding or pitting of cornea and/or thickening of the iris Score 3: Moderate clouding or pitting of cornea and/or thickening of the iris Score 4: Intense clouding orpitting of cornea and/or thickening of the iris

A follow-up visit is done after 24 hours to assess any adverse effect after the Product application

Detailed Description: Not available

Recruitment & Eligibility

Status: Not Yet Recruiting

Sex: All

Target Recruitment: 32

Inclusion Criteria

Individual should have ITA angle in the range of 18 t0 40, 41 to 55, and greater than 56 2.
Individuals free of any dermatological or systemic disorder which would interfere with the results, at the discretion of the investigator.
Individuals who have completed a preliminary medical history evaluation.
Individuals who have read, understood and signed an informed consent document relating to the specific study to which they are subscribing.
Individuals with no known abnormal response to sunlight.

Exclusion Criteria

1.Individuals taking medication which in the opinion of the investigator would mask or interfere with the results.
2.Individuals with chronic skin allergies.
3.Individuals with suntan or sunburn.
4.Individuals with abnormal reaction to the sun.
5.Pregnant or lactating females.
6.Subjects accustomed to using sun beds.
7.Subjects who have participated in an SPF study within the last two months.

Study & Design

Study Type: PMS

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
1.Change in conjunctival inflammation	0min, 1min, 5min
2. Change in cornea and iris inflammation	0min, 1min, 5min
3. Change in Subject Discomfort	0min, 1min, 5min

Secondary Outcome Measures

Name	Time	Method
Not Applicable	Not Applicable

Trial Locations

Locations (1): CCFT laboratories
🇮🇳
Meerut, UTTAR PRADESH, India
CCFT laboratories
🇮🇳Meerut, UTTAR PRADESH, India
Dr Ishika Gandhi
Principal investigator
7455086734
ishika02gandhi@gmail.com