A Clinical Study of Systane® Lid Wipes in Brazil

N/ACompletedNCT02380261

Alcon Research35 enrolled

Overview

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

Study Type

INTERVENTIONAL

Allocation

Masking

SINGLE

Enrollment

Conditions

Ocular Tolerance Skin Tolerance

Interventions

Systane® Lid WipesOTHER

Commercially-marketed, individually-packaged, pre-moistened eyelid wipe for daily cleaning

Eligibility

Sex: ALLMin age: 18 YearsMax age: 70 YearsHealthy volunteers:

Medical Language ↔ Plain English

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.

Locations (1)

Novartis Biociencias SA

São Paulo, Brazil

Outcomes

Primary Outcomes

Number of Participants With a Contact-dermatitis Adverse Reaction

Participants were assessed by a dermatologist. Contact-dermatitis adverse reaction was characterized by the presence of one or more of the following symptoms or signs: strong itching sensation, erythema, edema, desquamation, papules or vesicles. Both eyes contributed to the analysis.

Time frame: Day 21

Number of Participants With Ocular Clinical Signs and Discomfort Sensations

Participants were assessed by an ophthalmologist. Ocular clinical signs included palpebral edema, conjunctival edema, orbicular secretion, keratoconus, blepharitis, meibomitis, pterygium, hyperemia, chemosis, keratitis, secretion and lacrimation. Both eyes contributed to the analysis.

Time frame: Day 21

Data from ClinicalTrials.gov

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