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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT03060005
Other study ID # 2017DHLL001
Secondary ID
Status Recruiting
Phase N/A
First received January 23, 2017
Last updated May 14, 2017
Start date May 1, 2017
Est. completion date September 1, 2017

Study information

Verified date May 2017
Source Tung Wah Hospital
Contact Chi Zhang, MD,PhD
Phone +8613790077756
Email mike0946@163.com
Is FDA regulated No
Health authority
Study type Interventional

Clinical 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 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.


Recruitment information / eligibility

Status Recruiting
Enrollment 80
Est. completion date September 1, 2017
Est. primary completion date August 1, 2017
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Female
Age group 50 Years to 60 Years
Eligibility Inclusion Criteria:

- 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

Exclusion Criteria:

- The control history of autoimmune disease

Study Design


Intervention

Drug:
Tears Naturale Forte
This medication is used to relieve dry, irritated eyes
liposic
Liposic eye gel contain the active ingredient carbomer, which is a type of medicine known as an eye lubricant. It is used for the treatment of the symptoms of dry eye.

Locations

Country Name City State
China Tungwah Hospital of Sun Yat-sen University Dongguan Guangdong

Sponsors (1)

Lead Sponsor Collaborator
Tung Wah Hospital

Country where clinical trial is conducted

China, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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 up to 3 months after tear substitutes apply
Primary 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 up to 3 months after tear substitutes apply
Primary 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. up to 3 months after tear substitutes apply
Primary 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). up to 3 months after tear substitutes apply
Primary 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. up to 3 months after tear substitutes apply
Primary 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. up to 3 months after tear substitutes apply
Secondary 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 up to 3 months after tear substitutes apply
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