Efficacy of Diacerein on Ocular Surface Disease in Degenerative Arthritis Patients

Completed

• Conditions: Ocular Surface Disease; Diacerein; Osteoarthritis
• Interventions: Drug: Diacerein

• Registration Number: NCT04351100
• Lead Sponsor: Chulalongkorn University

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2019-10-01
• Study First Submitted: 2020-04-10
• Study First Submitted QC: 2020-04-16
• Study First Posted: 2020-04-17
• Primary Completion: 2020-07-31
• Study Completion: 2020-07-31
• Status Verified: 2021-08
• Last Update Submitted: 2021-08-09
• Last Update Posted: 2021-08-10

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 34

Inclusion Criteria

1. Osteoarthritis with
2. Ocular surface index score ≥ 13 with
3. Corneal staining score ≥ 3

Exclusion Criteria

1. Allergic to diacerein
2. Use Cyclosporin within 30 days
3. Eyelid problem
4. Change artificial tear while in the study
5. Pregnancy or breast feeding

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Diacerein group	Diacerein	Osteoarthritis and dry eye patients treated with Diacerein

Primary Outcome Measures

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

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Faculty of medicine, Chulalongkorn university; 🇹🇭 Bangkok, Thailand