A Clinical Study of Systane® Lid Wipes in Brazil NCT02380261

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.

Clinical Trial Details — Status: Completed

The purpose of this study is to verify the skin and ocular tolerance of the product Systane® Lid Wipes.

Recruitment information / eligibility
Status	Completed
Enrollment	35
Est. completion date	October 2015
Est. primary completion date	October 2015
Accepts healthy volunteers	Accepts Healthy Volunteers
Gender	Both
Age group	18 Years to 70 Years
Eligibility	Inclusion Criteria: - Must sign informed consent. - Agree to adhere to the procedures and requirements of the study. - Wears makeup daily. - Other protocol-specified inclusion criteria may apply. Exclusion Criteria: - Pregnant or breastfeeding. - Ocular conditions as specified in protocol. - Medical conditions as specified in protocol. - Skin conditions as specified in protocol. - Other protocol-specified exclusion criteria may apply.

Intervention Model: Single Group Assignment, Masking: Single Blind (Subject)

Other:
• Systane® Lid Wipes
Commercially-marketed, individually-packaged, pre-moistened eyelid wipe for daily cleaning

Locations
Country	Name	City	State
Brazil	Novartis Biociencias SA	Sao Paulo

Sponsors *(2)*
Lead Sponsor	Collaborator
Alcon Research	NOVARTIS BIOCIENCIAS S/A

Brazil,

Outcome
Type	Measure	Time frame	Safety issue
Primary	Number of subjects with a contact-dermatitis adverse reaction	Day 21	Yes
Primary	Number of subjects with ocular clinical signs and discomfort sensations	Day 21	Yes
Secondary	Acceptance of product as reported through subject questionnaire	Day 21	No