Dry Eye SyndromesNCT02011776
A Randomized, Parallel-Group Comparison Study of Topical Corticosteroids in Dry Eye Patients With Sjögren Syndrome
An observational study of Dry Eye Syndromes and Sjögren Syndrome, run by Santen Pharmaceutical(China) Co.,LTD at 1 site in China.
Trial summary
The purpose of this study is to evaluate the effectiveness of fluorometholone combined with sodium hyaluronate eye drops in the treatment of Sjögren syndrome. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Dry Eye Syndromes, Sjögren Syndrome
- How many people
- 35 participants
- Where
- 1 siteChina
- Study dates
- Mar 2013to Nov 2013
- How long will I take part?
- 8 Weeks
- Phase
- Observational
- 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 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: the people who suffered from the dry eye disease coused by the Sjögren syndrome
Who may be able to join
- willing to participate in this clinical study, and signed informed consent
- age from 18 to 70 years old,both genders are permitted
- diagnosed as the Sjögren syndrome
- have the symptoms and signs of dry eye disease as below:
- have at least 2 symptoms such as dryness,foreign body sensation ,eye strain,conjunctival congestion,secretion.The summed up score of symptoms greater than 6.
- the score of tear-film break up time less than 5 seconds or the score of Schirmer test less than 5mm/5min.
- the score of corneal fluorescein staining greater than 3.
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
About this study
The purpose of this study is to evaluate the effectiveness of fluorometholone combined with sodium hyaluronate eye drops in the treatment of Sjögren syndrome.
- Conditions
- Dry Eye Syndromes, Sjögren Syndrome
- Keywords
- Corticosteroids Dry Eye Sjögren syndrome inflammation treatment
- Medical subject headings
- Dry Eye Syndromes, Sjogren's Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Group 1 | using the 0.1% fluorometholone eye drops combined with the 0.1% sodium hyaluronate eye drops | |
| Group 2 | using the 0.5% cyclosporin A eye drops combined with 0.1% sodium hyaluronate eye drops |
What is being measured
The primary outcome is the main question the study is designed to answer.
tear-film breakup time
stain the cornea with the fluorescein; close the eye; open the eye and keep the eye open,count the seconds until the first black spot appears.
Measured: the enrolling day,2 weeks after treatment,4 weeks after treatment,8 weeks after treatment
Schirmer test I without anesthesia
put the Schirmer test strip into the lower conjunctival sac; close the eye for 5 minutes; read the score of the test strip
Measured: the enrolling day,2 weeks after treatment,4 weeks after treatment, 8 weeks after treatment
corneal fluorescein staining
Fluorescein staining scores were measured on 0-3 point scale, in each quarter of corneal zone: 0(No staining), 1(some staining), 2(Staining in more than a half of the area), 3(Staining in the whole area).
Measured: the enrolling day,2 weeks after treatment,4 weeks after treatment,8 weeks after treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Dec 2013 (estimated)
- Study startMar 2013
- Primary completionAug 2013
- Study completionNov 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Dry Eye SyndromesStudies of the same condition, open and under way.
- 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
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 35 participants (actual)
- Target duration
- 8 Weeks
Sponsor and investigators
- Lead sponsor
- Santen Pharmaceutical(China) Co.,LTD
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Principal investigator, Lan Gong, Santen Pharmaceutical(China) Co.,LTD
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02011776
- Sponsor's protocol ID
- FML-001
- Other IDs
- FML-001
- Status last verified
- Jul 2014
- First submitted
- 10 Dec 2013
- Last updated
- 9 Jul 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Jul 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Parallel-Group Comparison Study of Topical Corticosteroids in Dry Eye Patients With Sjögren Syndrome
- ClinicalTrials.gov ID
- NCT02011776
- Acronym / sponsor ID
- FML-001
- Conditions
- Dry Eye Syndromes, Sjögren Syndrome
- Keywords
- Corticosteroids Dry Eye Sjögren syndrome inflammation treatment
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 35 participants (actual)
- Lead sponsor
- Santen Pharmaceutical(China) Co.,LTDIndustry (pharma, biotech, devices)
- Study start
- Mar 2013
- Primary completion
- Aug 2013 (actual)
- Study completion
- Nov 2013 (actual)
- First posted
- 13 Dec 2013 (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 evaluate the effectiveness of fluorometholone combined with sodium hyaluronate eye drops in the treatment of Sjögren syndrome.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Target follow-up
- 8 Weeks
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group 1 | – | –using the 0.1% fluorometholone eye drops combined with the 0.1% sodium hyaluronate eye drops |
| Group 2 | – | –using the 0.5% cyclosporin A eye drops combined with 0.1% sodium hyaluronate eye drops |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- the people who suffered from the dry eye disease coused by the Sjögren syndrome
Key inclusion criteria (7 listed)
- willing to participate in this clinical study, and signed informed consent
- age from 18 to 70 years old,both genders are permitted
- diagnosed as the Sjögren syndrome
- have the symptoms and signs of dry eye disease as below:
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
tear-film breakup time
Time frame: the enrolling day,2 weeks after treatment,4 weeks after treatment,8 weeks after treatment
stain the cornea with the fluorescein; close the eye; open the eye and keep the eye open,count the seconds until the first black spot appears.
Schirmer test I without anesthesia
Time frame: the enrolling day,2 weeks after treatment,4 weeks after treatment, 8 weeks after treatment
put the Schirmer test strip into the lower conjunctival sac; close the eye for 5 minutes; read the score of the test strip
corneal fluorescein staining
Time frame: the enrolling day,2 weeks after treatment,4 weeks after treatment,8 weeks after treatment
Fluorescein staining scores were measured on 0-3 point scale, in each quarter of corneal zone: 0(No staining), 1(some staining), 2(Staining in more than a half of the area), 3(Staining in the whole area).
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 9 Jul 2014.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Dry Eye Syndromes and Sjögren Syndrome, run by Santen Pharmaceutical(China) Co.,LTD at 1 site in China.
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 7 inclusion and 0 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 9 Jul 2014. 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 China. 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?
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?
tear-film breakup time (time frame: the enrolling day,2 weeks after treatment,4 weeks after treatment,8 weeks after treatment). The study lists 3 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 9 Jul 2014.