A Clinical Study of Systane® Lid Wipes in Brazil
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
1 other identifier
interventional
35
1 country
1
Brief Summary
The purpose of this study is to verify the skin and ocular tolerance of the product Systane® Lid Wipes.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Sep 2015
Shorter than P25 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
February 27, 2015
CompletedFirst Posted
Study publicly available on registry
March 5, 2015
CompletedStudy Start
First participant enrolled
September 1, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 1, 2015
CompletedStudy Completion
Last participant's last visit for all outcomes
October 1, 2015
CompletedResults Posted
Study results publicly available
November 18, 2016
CompletedNovember 18, 2016
August 1, 2016
1 month
February 27, 2015
August 9, 2016
September 29, 2016
Conditions
Outcome Measures
Primary Outcomes (2)
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.
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.
Day 21
Study Arms (1)
Systane
EXPERIMENTALSystane® Lid Wipes, 1 per eyelid, used once and discarded after each use, for 21 days
Interventions
Commercially-marketed, individually-packaged, pre-moistened eyelid wipe for daily cleaning
Eligibility Criteria
You may qualify if:
- Must sign informed consent.
- Agree to adhere to the procedures and requirements of the study.
- Wears makeup daily.
You may not qualify if:
- Pregnant or breastfeeding.
- Ocular conditions as specified in protocol.
- Medical conditions as specified in protocol.
- Skin conditions as specified in protocol.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Alcon Researchlead
- NOVARTIS BIOCIENCIAS S/Acollaborator
Study Sites (1)
Novartis Biociencias SA
São Paulo, 04636-000, Brazil
Results Point of Contact
- Title
- Dir Clinical Operations - LACAR, GCRA
- Organization
- Alcon, a Novartis company
Study Officials
- STUDY DIRECTOR
Medical Director
Alcon Brazil
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- SINGLE
- Who Masked
- PARTICIPANT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
February 27, 2015
First Posted
March 5, 2015
Study Start
September 1, 2015
Primary Completion
October 1, 2015
Study Completion
October 1, 2015
Last Updated
November 18, 2016
Results First Posted
November 18, 2016
Record last verified: 2016-08