Efficacy of Diacerein on Ocular Surface Disease in Degenerative Arthritis Patients

Study Overview
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Brief Summary
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Dry eyes is multi-factorial disease which inflammation play etiological role. Diacerein is drug which has anti-inflammatory effect by antagonist Interleukin-1, decrease Interleukin-1 receptor, increase Interleukin-1 Receptor antagonist. This observational study enrolled participants who going to take diacerein for osteoarthritis, measure corneal staining score, Ocular surface disease index score, Tear Osmolarity, Tear break up time, Schirmer 1 test, Interleukin-1 Receptor antagonist, Interleukin-1 alpha, Interleukin-1 beta level in tear at the time of enrollment and after 2 months.

Official Title
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Efficacy of Diacerein on Ocular Surface Disease in Degenerative Arthritis Patients

Conditions
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Ocular Surface Disease, Osteoarthritis, Diacerein

Intervention / Treatment
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* Drug: Diacerein


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Osteoarthritis with Ocular surface index score ≥ 13 with Corneal staining score ≥ 3 Exclusion Criteria: Allergic to diacerein Use Cyclosporin within 30 days Eyelid problem Change artificial tear while in the study Pregnancy or breast feeding

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Diacerein group<br>Osteoarthritis and dry eye patients treated with Diacerein | Drug: Diacerein<br>* Diacerein prescribing by orthopedist. Dry eye sign and symptom was asses before start diacerein and after 2 months.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Corneal staining score change from baseline at 2 months | Stain Cornea with Fluorescine, count and score staining at the cornea according to National eye institute : score 0-15 (0=no staining) | At the time of enrollment and 2 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Ocular surface disease index score | Ocular Surface Disease Index : 0-100 (0=no any symptom) | At the time of enrollment and 2 months | 
| Tear Osmolarity | Use Tearlab to measure tear osmolarity | At the time of enrollment and 2 months | 
| Tear break up time | Stain Cornea with Fluorescine, wait until tear film break, record time that tear break | At the time of enrollment and 2 months | 
| Schirmer 1 test | place Schirmer strip at the fornix without anesthesia, wait for 5 min, record tear distance | At the time of enrollment and 2 months | 
| Interleukin-1 receptor antagonist, Interleukin-1 alpha, Interleukin-1 beta level in tear | Extract tear from Schirmer strip and use Bioplex for cytokine measurement of Interleukin-1 receptor antagonist(picogram/ml), Interleukin-1 alpha(picogram/ml), Interleukin-1 beta(picogram/ml) | At the time of enrollment and 2 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Dry Eye Syndromes, Osteoarthritis, Ocular surface inflammation, Interleukin-1, Interleukin-1 receptor antagonist