Oral Rebamipide in Sjogren Syndrome
Not Applicable
Completed
- Conditions
- Health Condition 1: null- PATIENTS WITH DRY EYE RELATED TO SJOGRENS SYNDROMEHealth Condition 2: M350- Sicca syndrome [Sjogren]
- Registration Number
- CTRI/2020/11/029161
- Lead Sponsor
- Indian Council of Medical research
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 40
Inclusion Criteria
Patients with
a) Dry Eye disease in Sjogrens Syndrome
b) Schirmers test basic secretion test 5-10mm
c)Tear Fluorescein Break Up Time < 10 seconds
d)Willing to participate in the study
e)Age between 18 and 65 years
Exclusion Criteria
a) Patients with punctal plugs
b)Patients with severe eyelid disease
(trichiasis)
c)Patients having undergone LASIK less than 1
year prior to observation period.
d)Patients having undergone other ocular
surgery (e.g. cataract) less than 1 year
prior to observatonal period ago.
e)Patients below 18 years of age ,above
65 years
f)Pregnant/lactating patient
g)Patients on drugs known to affect tear
film parameters i.e. beta blockers, anti-
cholinergics, anti-histaminics and oral
contraceptives.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method a.Tear Break Up Time <br/ ><br>b. PAS positive cell density by Impression Cytology <br/ ><br>Timepoint: EVERY MONTH FOR 6 MONTHS OF WHICH <br/ ><br>3 MONTHS WITH TREATMENT AND 3 MONTHS WITHOUT TREATMENT <br/ ><br>
- Secondary Outcome Measures
Name Time Method 1 Changes in OSDI Score <br/ ><br>2 Lissamine green staining <br/ ><br>3Schirmer test <br/ ><br>4Improvement of Xerostomia <br/ ><br> A)Symptomatic improvement <br/ ><br>B)Saxon Test <br/ ><br>Timepoint: EVERY MONTH FOR 6 MONTHS OF WHICH <br/ ><br>3 MONTHS WITH TREATMENT AND 3 MONTHS WITHOUT TREATMENT <br/ ><br>