A Clinical Study of Systane® Lid Wipes in Brazil

Not Applicable

Completed

• Conditions: Skin Tolerance; Ocular Tolerance
• Interventions: Other: Systane® Lid Wipes

• 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

Study Timeline

• Study First Submitted: 2015-02-27
• Study First Submitted QC: 2015-03-04
• Study First Posted: 2015-03-05
• Study Start: 2015-09
• Primary Completion: 2015-10
• Study Completion: 2015-10
• Status Verified: 2016-08
• Results First Submitted: 2016-08-09
• Results First Submitted QC: 2016-09-29
• Last Update Submitted: 2016-09-29
• Results First Posted: 2016-11-18
• Last Update Posted: 2016-11-18

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

Arm && Interventions

Group	Intervention	Description
Systane	Systane® Lid Wipes	Systane® Lid Wipes, 1 per eyelid, used once and discarded after each use, for 21 days

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.

Trial Locations

Locations (1)

Novartis Biociencias SA; 🇧🇷 Sao Paulo, Brazil