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OpenTrials
Completed

NCT Number: NCT02380261

A Clinical Study of Systane® Lid Wipes in Brazil

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

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Key information

Conditions

Ocular Tolerance Skin Tolerance

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Novartis Biociencias SA

São Paulo, 04636-000, Brazil

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Systane® Lid Wipes

Other

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

Primary outcomes

  1. Number of Participants With a Contact-dermatitis Adverse Reaction

    Time frame: 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.

  2. Number of Participants With Ocular Clinical Signs and Discomfort Sensations

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Alcon Research

Industry

Collaborators

  • NOVARTIS BIOCIENCIAS S/A

Registry information

Official study title

Assessment Of The Skin And Ocular Tolerance Of The Product Systane® Lid Wipes (050343-01) And Assessment Of The Study Subject Acceptance, Under Normal Use Conditions

Important dates

Study start
2015
Primary completion
2015
Study completion
2015
First posted
Mar 5, 2015
Registry last updated
Nov 18, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.