Meibomian Gland DysfunctionNCT03434106
Sjögren's Syndrome Is Associated With Meibomian Gland Dysfunction
A study testing liposic and Tears Naturale Forte in people with Meibomian Gland Dysfunction and Sjögren's Syndrome, run by LanZhou University at 1 site in China.
Trial summary
The investigators hypothesize that the dry eye caused by SS may include the evaporative type, resulting from the MGD. Furthermore, the investigators hypothesize that both pSS and sSS are associated with MGD.To test our hypothesis, we conducted a prospective clinical study in patients with SS (both pSS and sSS) and… Read more about this study
- Who is it for?
- Ages 45 to 60 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Meibomian Gland Dysfunction, Sjögren's Syndrome
- What is being tested?
- liposic and Tears Naturale Forte
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteChina
- Study dates
- 10 Feb 2018to 30 Jun 2018
- 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 45 to 60 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- All the subjects are female and age between 50-60 years
- Patients with primary SS fulfilled the criteria established by the European Study Group
- Patients with SLE and RA met the criteria set by the American College of Rheumatology
Who cannot join
- The control history of autoimmune disease
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Lanzhou University Second Hospital
Lanzhou, Gansu
Jingmin Yuan, +(86)15002626556, 15002626556@163.com
About this study
The investigators hypothesize that the dry eye caused by SS may include the evaporative type, resulting from the MGD. Furthermore, the investigators hypothesize that both pSS and sSS are associated with MGD.To test our hypothesis, we conducted a prospective clinical study in patients with SS (both pSS and sSS) and MGD, and the normal population All subjects were matched for both age and gender and assessed for tear function and ocular surface signs and symptoms.
- Conditions
- Meibomian Gland Dysfunction, Sjögren's Syndrome
- Being tested
- liposic, Tears Naturale Forte
- Keywords
- meibomian gland dysfunction, Sjögren's syndrome, dry eye disease
- Medical subject headings
- Meibomian Gland Dysfunction, Sjogren's Syndrome, Dry Eye Syndromes
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
liposicDrug
Also called Carbomer
Liposic eye gel contain the active ingredient carbomer, which is a type of medicine known as an eye lubricant. It is used for the treatmen
Tears Naturale ForteDrug
Also called DEXTRAN/HYPROMELLOSE/GLYCERIN
This medication is used to relieve dry, irritated eyes
| Study group | Role | What they receive |
|---|---|---|
| primary Sjögren's syndrome | Experimental | The female patients with primary Sjögren's syndrome receive the Tears Naturale Forte and Liposic. Receives: Drug: liposic; Drug: Tears Naturale Forte |
| secondary Sjögren's syndrome | Experimental | The female patients with secondary Sjögren's syndrome receive Tears Naturale Forte and Liposic. Receives: Drug: liposic; Drug: Tears Naturale Forte |
| meibomian gland dysfunction | Experimental | The female patients with meibomian gland dysfunction receive the Tears Naturale Forte and Liposic. Receives: Drug: liposic; Drug: Tears Naturale Forte |
| control | Experimental | the female had no history of autoimmune disease receive the Tears Naturale Forte and Liposic. Receives: Drug: liposic; Drug: Tears Naturale Forte |
What is being measured
The primary outcome is the main question the study is designed to answer.
Ocular Surface Disease Index
The OSDI questionnaire is used to quantify the dry eye symptoms. Subjects will be asked questions regarding the dry eye symptoms that they had experienced; the OSDI questions is drawn from 3 different subscales: ocular symptoms, vision-related functions, and environmental triggers. Each answer is scored on a 4-point scale from zero (indicating no problems) to four (indicating a significant problem). Responses to all of the questions are combined to generate a composite OSDI score that ranges from 0 to 100, with higher OSDI scores indicating more severe symptoms. Symptoms of dry eye, such as dryness, burning, foreign body sensation, stabbing pain, photophobia, and visual fluctuations, are also noted
Measured: up to 3 months after tear substitutes apply
meibomian gland function
assessment of the quality of meibomian gland secretions, according to a published classification system (21). In brief, the grading scheme was "0" for clear excreta with small particles, "1" for opaque excreta with normal viscosity, "2" for opaque excreta with increased viscosity, and "3" for secreta that retained shape after digital expression.
Measured: up to 3 months after tear substitutes apply
fluorescein staining of the cornea
Upper, lower, nasal, temporal and central quadrants were used. Superficial punctate keratopathy (SPK) in the cornea was scored from 0 to 3 in each quadrant: 0, no staining in the cornea; 1, <5 punctuate stains; 2, >5 punctuate stains but <10; and 3, >10 or filamentous staining detected. The total number was obtained by adding the scores of the four quadrants for each eye (0-15).
Measured: up to 3 months after tear substitutes apply
noninvasive tear breakup time
Four IR diodes were set on the Keratograph 5 (Oculus, Wetzlar, Germany) and arranged in two pairs, located one above the other. The red ring illumination used for corneal topography was deactivated; this ensured a dark background for the examination. An illuminated ring pattern was then projected onto the cornea. At the start of the recording, the subject will be asked to blink his or her eyes three times and then to keep them open as long as possible. Irregularities in the reflected image will be observed closely. Special attention will be given to distortions and gaps in individual rings and the time such deviations from the original ring pattern took to occur. The examination will be recorded on video.
Measured: up to 3 months after tear substitutes apply
Schirmer's test with and without anesthesia
The Schirmer test without anesthesia (S1T) for tear secretion function will be performed by inserting a 30-mm Schirmer tear test strip (Jingming, Tianjing, China) into the inferior fornix at the junction of the middle and lateral thirds of the lower eyelid margin. Schirmer test strips will remain in place for 5 minutes with the eyes closed. The extent of wetting will be subsequently measured according to the scale provided by the manufacturer. Potential scores ranged from 0 to 30 mm, with lower scores indicating greater tear production abnormalities.
Measured: up to 3 months after tear substitutes apply
Secondary outcomes (2)
tear meniscus
The subject will be asked to blink her eyes once ,then the image of tear meniscus height will be captured by a Keratograph 5 (Oculus, Wetzlar, Germany).After that tear meniscus height will be measured at the centre of the lower lid margin. This performance will be taken three times and the average value will be recorded.
Measured: up to 3 months after tear substitutes apply
rose bengal staining of the conjunctiva
rose bengal staining (graded on a 0-3 scale) of the conjunctiva (six nasal and temporal areas) and the whole cornea.
Measured: up to 3 months after tear substitutes apply
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Feb 2018
- Study start10 Feb 2018
- Primary completion31 May 2018 (estimated)
- Study completion30 Jun 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Meibomian Gland DysfunctionStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- LanZhou University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jingmin Yuan, MD, LanZhou University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03434106
- Sponsor's protocol ID
- 2018A-005
- Status last verified
- Feb 2018
- First submitted
- 9 Feb 2018
- Last updated
- 15 Feb 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Feb 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Sjögren's Syndrome Is Associated With Meibomian Gland Dysfunction
- ClinicalTrials.gov ID
- NCT03434106
- Acronym / sponsor ID
- 2018A-005
- Conditions
- Meibomian Gland Dysfunction, Sjögren's Syndrome
- Keywords
- meibomian gland dysfunction, Sjögren's syndrome, dry eye disease
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- LanZhou UniversityUniversity, hospital or other
- Study start
- 10 Feb 2018 (actual)
- Primary completion
- 31 May 2018 (estimated)
- Study completion
- 30 Jun 2018 (estimated)
- First posted
- 15 Feb 2018 (actual)
- 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 investigators hypothesize that the dry eye caused by SS may include the evaporative type, resulting from the MGD. Furthermore, the investigators hypothesize that both pSS and sSS are associated with MGD.To test our hypothesis, we conducted a prospective clinical study in patients with SS (both pSS and sSS) and MGD, and the normal population All subjects were matched for both age and gender and assessed for tear function and ocular surface signs and symptoms.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| primary Sjögren's syndrome | Experimental | Drug: liposic, Drug: Tears Naturale ForteThe female patients with primary Sjögren's syndrome receive the Tears Naturale Forte and Liposic. |
| secondary Sjögren's syndrome | Experimental | Drug: liposic, Drug: Tears Naturale ForteThe female patients with secondary Sjögren's syndrome receive Tears Naturale Forte and Liposic. |
| meibomian gland dysfunction | Experimental | Drug: liposic, Drug: Tears Naturale ForteThe female patients with meibomian gland dysfunction receive the Tears Naturale Forte and Liposic. |
| control | Experimental | Drug: liposic, Drug: Tears Naturale Fortethe female had no history of autoimmune disease receive the Tears Naturale Forte and Liposic. |
Who may qualify
- Ages
- 45 to 60 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- All the subjects are female and age between 50-60 years
- Patients with primary SS fulfilled the criteria established by the European Study Group
- Patients with SLE and RA met the criteria set by the American College of Rheumatology
Key exclusion criteria (1 listed)
- The control history of autoimmune disease
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 |
|---|---|---|
| liposicAlso: CarbomerLiposic eye gel contain the active ingredient carbomer, which is a type of medicine known as an eye lubricant. It is used for the treatmen | Drug | control, meibomian gland dysfunction, primary Sjögren's syndrome, secondary Sjögren's syndrome |
| Tears Naturale ForteAlso: DEXTRAN/HYPROMELLOSE/GLYCERINThis medication is used to relieve dry, irritated eyes | Drug | control, meibomian gland dysfunction, primary Sjögren's syndrome, secondary Sjögren's syndrome |
Primary outcome
Ocular Surface Disease Index
Time frame: up to 3 months after tear substitutes apply
The OSDI questionnaire is used to quantify the dry eye symptoms. Subjects will be asked questions regarding the dry eye symptoms that they had experienced; the OSDI questions is drawn from 3 different subscales: ocular symptoms, vision-related functions, and environmental triggers. Each answer is scored on a 4-point scale from zero (indicating no problems) to four (indicating a significant problem). Responses to all of the questions are combined to generate a composite OSDI score that ranges from 0 to 100, with higher OSDI scores indicating more severe symptoms. Symptoms of dry eye, such as dryness, burning, foreign body sensation, stabbing pain, photophobia, and visual fluctuations, are also noted
meibomian gland function
Time frame: up to 3 months after tear substitutes apply
assessment of the quality of meibomian gland secretions, according to a published classification system (21). In brief, the grading scheme was "0" for clear excreta with small particles, "1" for opaque excreta with normal viscosity, "2" for opaque excreta with increased viscosity, and "3" for secreta that retained shape after digital expression.
fluorescein staining of the cornea
Time frame: up to 3 months after tear substitutes apply
Upper, lower, nasal, temporal and central quadrants were used. Superficial punctate keratopathy (SPK) in the cornea was scored from 0 to 3 in each quadrant: 0, no staining in the cornea; 1, <5 punctuate stains; 2, >5 punctuate stains but <10; and 3, >10 or filamentous staining detected. The total number was obtained by adding the scores of the four quadrants for each eye (0-15).
noninvasive tear breakup time
Time frame: up to 3 months after tear substitutes apply
Four IR diodes were set on the Keratograph 5 (Oculus, Wetzlar, Germany) and arranged in two pairs, located one above the other. The red ring illumination used for corneal topography was deactivated; this ensured a dark background for the examination. An illuminated ring pattern was then projected onto the cornea. At the start of the recording, the subject will be asked to blink his or her eyes three times and then to keep them open as long as possible. Irregularities in the reflected image will be observed closely. Special attention will be given to distortions and gaps in individual rings and the time such deviations from the original ring pattern took to occur. The examination will be recorded on video.
Schirmer's test with and without anesthesia
Time frame: up to 3 months after tear substitutes apply
The Schirmer test without anesthesia (S1T) for tear secretion function will be performed by inserting a 30-mm Schirmer tear test strip (Jingming, Tianjing, China) into the inferior fornix at the junction of the middle and lateral thirds of the lower eyelid margin. Schirmer test strips will remain in place for 5 minutes with the eyes closed. The extent of wetting will be subsequently measured according to the scale provided by the manufacturer. Potential scores ranged from 0 to 30 mm, with lower scores indicating greater tear production abnormalities.
2 secondary outcomes
tear meniscus
Time frame: up to 3 months after tear substitutes apply
rose bengal staining of the conjunctiva
Time frame: up to 3 months after tear substitutes apply
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Feb 2018.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing liposic and Tears Naturale Forte in people with Meibomian Gland Dysfunction and Sjögren's Syndrome, run by LanZhou University 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 3 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: status not confirmed, as of the sponsor's last update on 15 Feb 2018. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Jingmin Yuan, MD (+(86)15002626556, 15002626556@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Ocular Surface Disease Index (time frame: up to 3 months after tear substitutes apply). The study lists 5 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 15 Feb 2018.