Ocular ToleranceNCT02380261
A Clinical Study of Systane® Lid Wipes in Brazil
A study testing Systane® Lid Wipes in people with Ocular Tolerance and Skin Tolerance, run by Alcon Research at 1 site in Brazil.
Trial summary
The purpose of this study is to verify the skin and ocular tolerance of the product Systane® Lid Wipes. Read more about this study
- Who is it for?
- Ages 18 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Ocular Tolerance, Skin Tolerance
- What is being tested?
- Systane® Lid Wipes
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 35 participants
- Where
- 1 siteBrazil
- Study dates
- Sep 2015to Oct 2015
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official 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
The purpose of this study is to verify the skin and ocular tolerance of the product Systane® Lid Wipes.
- Conditions
- Ocular Tolerance, Skin Tolerance
- Being tested
- Systane® Lid Wipes
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Systane® Lid WipesOther
Commercially-marketed, individually-packaged, pre-moistened eyelid wipe for daily cleaning
| Study group | Role | What they receive |
|---|---|---|
| Systane | Experimental | Systane® Lid Wipes, 1 per eyelid, used once and discarded after each use, for 21 days Receives: Other: Systane® Lid Wipes |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: Day 21
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Mar 2015 (estimated)
- Study startSep 2015
- Primary completionOct 2015
- Study completionOct 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Ocular ToleranceStudies of the same condition, open and under way.
- More trials run by Alcon ResearchThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 35 participants (actual)
Sponsor and investigators
- Lead sponsor
- Alcon Research
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- NOVARTIS BIOCIENCIAS S/A
- Responsible party
- Sponsor
- Investigators
- Medical Director, Study director, Alcon Brazil
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02380261
- Sponsor's protocol ID
- EXR338-P001
- Status last verified
- Aug 2016
- First submitted
- 27 Feb 2015
- Last updated
- 18 Nov 2016
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Nov 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official 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
- ClinicalTrials.gov ID
- NCT02380261
- Acronym / sponsor ID
- EXR338-P001
- Conditions
- Ocular Tolerance, Skin Tolerance
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 35 participants (actual)
- Lead sponsor
- Alcon ResearchIndustry (pharma, biotech, devices)
- Collaborators
- NOVARTIS BIOCIENCIAS S/A
- Study start
- Sep 2015
- Primary completion
- Oct 2015 (actual)
- Study completion
- Oct 2015 (actual)
- First posted
- 5 Mar 2015 (estimated)
- Results
- Posted 18 Nov 2016
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to verify the skin and ocular tolerance of the product Systane® Lid Wipes.
Study design
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- Single blind (participant)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Systane | Experimental | Other: Systane® Lid WipesSystane® Lid Wipes, 1 per eyelid, used once and discarded after each use, for 21 days |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Systane® Lid WipesCommercially-marketed, individually-packaged, pre-moistened eyelid wipe for daily cleaning | Other | Systane |
Primary outcome
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.
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.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Nov 2016.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Medical Director study director
Alcon Brazil
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Systane® Lid Wipes in people with Ocular Tolerance and Skin Tolerance, run by Alcon Research at 1 site in Brazil.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 Nov 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Brazil. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 18 Nov 2016). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Participants With a Contact-dermatitis Adverse Reaction (time frame: Day 21). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Nov 2016.