Efficacy of Diacerein on Ocular Surface Disease in Degenerative Arthritis Patients

Osteoarthritis Clinical Trial

Official title:

Efficacy of Diacerein on Ocular Surface Disease in Degenerative Arthritis Patients

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04351100
• Other study ID #: IRB No. 469/62
• Status: Completed
• Start date: October 1, 2019
• Est. completion date: July 31, 2020

Study information

• Verified date: August 2021
• Source: Chulalongkorn University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 34
• Est. completion date: July 31, 2020
• Est. primary completion date: July 31, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Diacerein
• Ocular Surface Disease
• Osteoarthritis

Intervention

Drug:
• Diacerein
Diacerein prescribing by orthopedist. Dry eye sign and symptom was asses before start diacerein and after 2 months.

Locations

Country	Name	City	State
Thailand	Faculty of medicine, Chulalongkorn university	Bangkok

Sponsors (1)

Lead Sponsor	Collaborator
Chulalongkorn University

Country where clinical trial is conducted

Thailand, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Ocular surface disease index score	Ocular Surface Disease Index : 0-100 (0=no any symptom)	At the time of enrollment and 2 months
Secondary	Tear Osmolarity	Use Tearlab to measure tear osmolarity	At the time of enrollment and 2 months
Secondary	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
Secondary	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
Secondary	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