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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.

A study to evaluate the safety of the test product by Provocative Use Test (14 days) in healthy female subjects of varied eye conditions such as normal condition, sensitive condition and contact lens users. - NIL

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2015/11/006334
Enrollment
40
Registered
2015-11-02
Start date
Unknown
Completion date
Unknown
Last updated
2021-11-24

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

Conditions

None listed

Interventions

Intervention1: Eye Make-up remover/Make-up remover: Frequency of Use: Once daily Quantity of usage per application/dose: Approximately 5-7 drops A 14 days study Control Intervention1: NIL: NIL

Sponsors

ITC Life Science and Technology Centre
Lead Sponsor

Eligibility

Inclusion criteria

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

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.

Design outcomes

Primary

MeasureTime frame
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

MeasureTime frame
To evaluate the dermatological safety of the test productTimepoint: Day1,Day2,Day3,Day4,Day5,Day7,Day10,Day14

Countries

India

Contacts

Public ContactDrGeethaS

MS Clinical Research Pvt,Ltd

geetha.s@mscr.in918040917253

Outcome results

None listed

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