A study to evaluate the safety of the test product in healthy female subjects of normal eye condition, sensitive eye condition and contact lens users.

Not Applicable

Completed

Registration Number: CTRI/2015/11/006334

Lead Sponsor: ITC Life Science and Technology Centre

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Completed

Sex: Not specified

Target Recruitment: 40

Inclusion Criteria

•Female adult subjects in general good health as determined from a recent medical history.

•Subjects in the age group of 18-40 years (both ages inclusive).

•Subject with various eye conditions such as normal condition, sensitive condition and contact lens users in nearly equal ratio.

•Subjects willing to give a voluntary written informed consent, photography release and agree to come for regular follow up.

•Subjects willing to abide by and comply with the study protocol.

•Subjects who have not participated in a similar investigation in the past four weeks.

•Subjects who are willing not to participate in any other clinical study during participation in the current study.

Exclusion Criteria

•A known history or present condition of allergic response to any cosmetic products (eye/ facial cosmetic products).

•Subjects having eye infection or allergy.

•Subjects having extremely sensitive eye condition.

•Subjects having allergy to astringent based products.

•Subjects who are using any eye drops or artificial tear drops.

•Cutaneous disease which may influence the study result.

•Subjects on oral medications (e.g. steroids, anti-oxidant) which will compromise the study.

•Systemic treatment which may modify the cutaneous state on the day of inclusion or in the previous 30 days, including retinoid therapy.

•Subjects who are pregnant, lactating or nursing.

•Subject participating in any other cosmetic or therapeutic trial.

•Any underlying uncontrolled medical illness including diabetes mellitus, hypertension, liver disease or history of alcoholism, HIV, hepatitis, or any other serious medical illness as determined by the medical history.

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
To evaluate the safety of the test product in causing no ocular irritation on repeated use involving healthy female subjects of varied eye conditions such as normal condition, sensitive condition and contact lens usersTimepoint: Approximately 14 days for each subject.

Secondary Outcome Measures