A Clinical Study of Systane® Lid Wipes in Brazil
Not Applicable
Completed
- Conditions
- Skin ToleranceOcular Tolerance
- Registration Number
- NCT02380261
- Lead Sponsor
- Alcon Research
- Brief Summary
The purpose of this study is to verify the skin and ocular tolerance of the product Systane® Lid Wipes.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 35
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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Primary Outcome Measures
Name Time Method Number of Participants With a Contact-dermatitis Adverse Reaction Day 21 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.
Number of Participants With Ocular Clinical Signs and Discomfort Sensations Day 21 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.
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
Novartis Biociencias SA
🇧🇷Sao Paulo, Brazil
Novartis Biociencias SA🇧🇷Sao Paulo, Brazil