Dry Eye SyndromeNCT01483989
In Vivo Measurement of Corneal Epithelial Changes in Dry Eye Patients
A study testing SYSTANE® Gel Drop lubricant eye gel in people with Dry Eye Syndrome, run by Alcon Research.
Trial summary
The purpose of this study is to measure corneal epithelial changes in dry eye subjects using a novel lubricant eye gel. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Dry Eye Syndrome
- What is being tested?
- SYSTANE® Gel Drop lubricant eye gel
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 19 participants
- Where
- No sites listed yet
- Study dates
- Feb 2011to Jun 2011
- 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
- Subjects must have history of dry eye as determined by:
- Questionnaire
- Tear Film Break Up Time less than or equal to 10 seconds
- Schirmer's score of less than or equal to 5 mm
- Corneal staining greater than or equal to 3 in either eye, and
- Positive for conjunctival staining (greater than or equal to 1)
Who cannot join
- Patients cannot wear contact lenses within 1 week prior nor during the study, and cannot have a history of hypersensitivity to any component of Systane Gel Drops.
About this study
Official title: In Vivo Measurement of Corneal Epithelial Changes in Dry Eye(DE) Patients
The purpose of this study is to measure corneal epithelial changes in dry eye subjects using a novel lubricant eye gel.
Read the detailed description
The purpose of this study is to measure corneal epithelial changes in dry eye (DE) subjects using a novel lubricant eye gel.
- Conditions
- Dry Eye Syndrome
- Being tested
- SYSTANE® Gel Drop lubricant eye gel
- Keywords
- Dry Eye, Epithelial changes
- 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® Gel Drop lubricant eye gelOther
Also called Systane Gel
SYSTANE Gel Drops Lubricant Eye gel dosed (bilaterally) 3 times per day for the 28 day period.
| Study group | Role | What they receive |
|---|---|---|
| SYSTANE® Gel Drops Lubricant eye gel | Experimental | SYSTANE Gel Drops Lubricant Eye gel dosed (bilaterally) 3 times per day for the 28 day period. Receives: Other: SYSTANE® Gel Drop lubricant eye gel |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in epithelial irregularity following 4 weeks of treatment with a novel artificial tear gel.
The Changes in epithelial irregularity following 4 weeks of treatment with a novel artificial tear gel.
Measured: baseline and 28 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Dec 2011 (estimated)
- Study startFeb 2011
- Primary completionJun 2011
- Study completionJun 2011
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 Eye SyndromeStudies 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
- NCT01483989
- Sponsor's protocol ID
- SMA-09-49
- Status last verified
- Feb 2012
- First submitted
- 29 Nov 2011
- Last updated
- 18 Nov 2016
- Results posted
- No
- Data monitoring committee
- No
Publications
http://iovs.arvojournals.org/article.aspx?articleid=2351788
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
- In Vivo Measurement of Corneal Epithelial Changes in Dry Eye(DE) Patients
- ClinicalTrials.gov ID
- NCT01483989
- Acronym / sponsor ID
- SMA-09-49
- Conditions
- Dry Eye Syndrome
- Keywords
- Dry Eye, Epithelial changes
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 19 participants (actual)
- Lead sponsor
- Alcon ResearchIndustry (pharma, biotech, devices)
- Study start
- Feb 2011
- Primary completion
- Jun 2011 (actual)
- Study completion
- Jun 2011 (actual)
- First posted
- 2 Dec 2011 (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 purpose of this study is to measure corneal epithelial changes in dry eye subjects using a novel lubricant eye gel.
Detailed description
The purpose of this study is to measure corneal epithelial changes in dry eye (DE) subjects using a novel lubricant eye gel.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| SYSTANE® Gel Drops Lubricant eye gel | Experimental | Other: SYSTANE® Gel Drop lubricant eye gelSYSTANE Gel Drops Lubricant Eye gel dosed (bilaterally) 3 times per day for the 28 day period. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Questionnaire
- Tear Film Break Up Time less than or equal to 10 seconds
- Schirmer's score of less than or equal to 5 mm
- Corneal staining greater than or equal to 3 in either eye, and
- Positive for conjunctival staining (greater than or equal to 1)
Key exclusion criteria (1 listed)
- Patients cannot wear contact lenses within 1 week prior nor during the study, and cannot have a history of hypersensitivity to any component of Systane Gel Drops.
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® Gel Drop lubricant eye gelAlso: Systane GelSYSTANE Gel Drops Lubricant Eye gel dosed (bilaterally) 3 times per day for the 28 day period. | Other | SYSTANE® Gel Drops Lubricant eye gel |
Primary outcome
Changes in epithelial irregularity following 4 weeks of treatment with a novel artificial tear gel.
Time frame: baseline and 28 days
The Changes in epithelial irregularity following 4 weeks of treatment with a novel artificial tear gel.
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 publicationhttp://iovs.arvojournals.org/article.aspx?articleid=2351788
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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.
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® Gel Drop lubricant eye gel in people with Dry Eye Syndrome, 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 6 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?
Changes in epithelial irregularity following 4 weeks of treatment with a novel artificial tear gel. (time frame: baseline and 28 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 NCT01483989, 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.