Health Condition 1: null- PATIENTS WITH DRY EYE RELATED TO SJOGRENS SYNDROME Health Condition 2: M350- Sicca syndrome [Sjogren]
Conditions
Interventions
Intervention1: REBAMIPIDE: MUCIN SECRETOGAUGE, given by oral route for 3 months in intervention group in dose of 100 mg BID.
Control Intervention1: CARBOXY METHYL CELLULOSE: 0.5% CARBOXY METHYL CELLUL
Sponsors
Indian Council of Medical research
Eligibility
Inclusion criteria
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 d)Willing to participate in the study e)Age between 18 and 65 years
Exclusion criteria
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| a. Tear Break Up Time b. PAS positive cell density by Impression Cytology Timepoint: EVERY MONTH FOR 6 MONTHS OF WHICH 3 MONTHS WITH TREATMENT AND 3 MONTHS WITHOUT TREATMENT | — |
Secondary
| Measure | Time frame |
|---|---|
| 1 Changes in OSDI Score 2 Lissamine green staining 3Schirmer test 4Improvement of Xerostomia A)Symptomatic improvement B)Saxon Test Timepoint: EVERY MONTH FOR 6 MONTHS OF WHICH 3 MONTHS WITH TREATMENT AND 3 MONTHS WITHOUT TREATMENT | — |
Countries
India
Contacts
Public ContactVineet Mutha
All india Institute of Medical Sciences
Outcome results
None listed