An interventional study of liposic and Tears Naturale Forte in Meibomian Gland Dysfunction and Sjögren's Syndrome, sponsored by LanZhou University. Status unknown at 1 site in China. Open to female participants aged 45 Years to 60 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2018-02-15.
Sponsored by LanZhou University · Not applicable, Interventional, and Treatment
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.
172 studies on the registry are indexed under Meibomian Gland Dysfunction; 23 are open to participants now.
This study's planned enrollment of 60 is above the median of 50 across 138 interventional studies indexed under Meibomian Gland Dysfunction.
Browse Meibomian Gland Dysfunction studies →LanZhou University is the lead sponsor of 27 studies on the registry; 13 are open to participants now.
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Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
A condition in which the immune system attacks the body’s own tissues, such as rheumatoid arthritis, lupus, psoriasis, type 1 diabetes or inflammatory bowel disease.
Immunotherapy studies often leave out active autoimmune disease, and some name exceptions, such as thyroid disease on replacement hormone. Check the exceptions this study lists.
Autoimmune disease
A condition in which the immune system attacks the body’s own tissues, such as rheumatoid arthritis, lupus, psoriasis, type 1 diabetes or inflammatory bowel disease.
Immunotherapy studies often leave out active autoimmune disease, and some name exceptions, such as thyroid disease on replacement hormone. Check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
The female patients with primary Sjögren's syndrome receive the Tears Naturale Forte and Liposic.
Drug: liposic · Drug: Tears Naturale Forte
The female patients with secondary Sjögren's syndrome receive Tears Naturale Forte and Liposic.
Drug: liposic · Drug: Tears Naturale Forte
The female patients with meibomian gland dysfunction receive the Tears Naturale Forte and Liposic.
Drug: liposic · Drug: Tears Naturale Forte
the female had no history of autoimmune disease receive the Tears Naturale Forte and Liposic.
Drug: liposic · Drug: Tears Naturale Forte
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
Also known as: Carbomer
This medication is used to relieve dry, irritated eyes
Also known as: DEXTRAN/HYPROMELLOSE/GLYCERIN
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
Time frame: 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.
Time frame: 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).
Time frame: 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.
Time frame: 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.
Time frame: up to 3 months after tear substitutes apply
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.
Time frame: 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.
Time frame: up to 3 months after tear substitutes apply
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Studies of the drug tested here: Carboxypolymethylene
LanZhou University