Dry EyeNCT00946777
Barrier Function Measurement in Dry Eye Patients After Using Systane Ultra for 30 Days
A study testing Systane® Ultra in people with Dry Eye, run by Alcon Research.
Trial summary
The primary objective is to determine if there is a correlation between reductions in corneal staining and improvements in corneal barrier function. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Dry Eye
- What is being tested?
- Systane® Ultra
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 19 participants
- Where
- No sites listed yet
- Study dates
- Jul 2009to Sep 2009
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients must have moderate corneal staining and exhibit a need to use artificial tears.
Who cannot join
- Patients can not participate in any other ophthalmic drug or device clinical trial within 30 days of the baseline visit.
About this study
The primary objective is to determine if there is a correlation between reductions in corneal staining and improvements in corneal barrier function.
- Conditions
- Dry Eye
- Being tested
- Systane® Ultra
- Keywords
- Dry Eye Signs, barrier function
- Medical subject headings
- Dry Eye Syndromes
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Systane® UltraOther
Systane® Ultra 1-2 drops, 4 times per day for 30 days
| Study group | Role | What they receive |
|---|---|---|
| Systane® Ultra | Experimental | Not described Receives: Other: Systane® Ultra |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percent change from baseline of corneal fluorescein
Measured: 30 days
Secondary outcomes (1)
Adverse event occurence
Measured: 30 Days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jul 2009 (estimated)
- Study startJul 2009
- Primary completionSep 2009
- Study completionSep 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Dry EyeStudies 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
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 19 participants (actual)
Sponsor and investigators
- Lead sponsor
- Alcon Research
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00946777
- Sponsor's protocol ID
- SMA-09-04
- Status last verified
- Feb 2012
- First submitted
- 24 Jul 2009
- Last updated
- 18 Nov 2016
- Results posted
- No
- Data monitoring committee
- No
Publications
Fernandez KB, Epstein SP, Raynor GS, Sheyman AT, Massingale ML, Dentone PG, Landegger LD, Asbell PA. Modulation of HLA-DR in dry eye patients following 30 days of treatment with a lubricant eyedrop solution. Clin Ophthalmol. 2015 Jun 24;9:1137-45. doi: 10.2147/OPTH.S81355. eCollection 2015.
PubMed 26170605
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
- Barrier Function Measurement in Dry Eye Patients After Using Systane Ultra for 30 Days
- ClinicalTrials.gov ID
- NCT00946777
- Acronym / sponsor ID
- SMA-09-04
- Conditions
- Dry Eye
- Keywords
- Dry Eye Signs, barrier function
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 19 participants (actual)
- Lead sponsor
- Alcon ResearchIndustry (pharma, biotech, devices)
- Study start
- Jul 2009
- Primary completion
- Sep 2009 (actual)
- Study completion
- Sep 2009 (actual)
- First posted
- 27 Jul 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The primary objective is to determine if there is a correlation between reductions in corneal staining and improvements in corneal barrier function.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Systane® Ultra | Experimental | Other: Systane® Ultra |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Patients must have moderate corneal staining and exhibit a need to use artificial tears.
Key exclusion criteria (1 listed)
- Patients can not participate in any other ophthalmic drug or device clinical trial within 30 days of the baseline visit.
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® UltraSystane® Ultra 1-2 drops, 4 times per day for 30 days | Other | Systane® Ultra |
Primary outcome
Percent change from baseline of corneal fluorescein
Time frame: 30 days
1 secondary outcome
Adverse event occurence
Time frame: 30 Days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Nov 2016.
- Results publication: PubMed 26170605Fernandez KB, Epstein SP, Raynor GS, Sheyman AT, Massingale ML, Dentone PG, Landegger LD, Asbell PA. Modulation of HLA-DR in dry eye patients following 30 days of treatment with a lubricant eyedrop solution. Clin Ophthalmol. 2015 Jun 24;9:1137-45. doi: 10.2147/OPTH.S81355. eCollection 2015.
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Dry Eye
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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing Systane® Ultra in people with Dry Eye, run by Alcon Research.
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 1 inclusion and 1 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.
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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Percent change from baseline of corneal fluorescein (time frame: 30 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00946777, which also lists 1 linked publication.
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.