Efficacy of Diacerein on Ocular Surface Disease in Degenerative Arthritis Patients

NCT04351100 | Completed

• 1 other identifier: IRB No. 469/62
• Study Type: observational
• Target: 34
• Locations: 1 country
• Sites: 1

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.

Conditions

Ocular Surface Disease; Osteoarthritis; Diacerein

Keywords

Dry Eye Syndromes; Osteoarthritis; Ocular surface inflammation; Interleukin-1; Interleukin-1 receptor antagonist

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (5)

• Ocular surface disease index score

  At the time of enrollment and 2 months

• Tear Osmolarity

  At the time of enrollment and 2 months

• Tear break up time

  At the time of enrollment and 2 months

• Schirmer 1 test

  At the time of enrollment and 2 months

• Interleukin-1 receptor antagonist, Interleukin-1 alpha, Interleukin-1 beta level in tear

  At the time of enrollment and 2 months

Study Arms (1)

Diacerein group

Osteoarthritis and dry eye patients treated with Diacerein

Drug: Diacerein

Interventions

Diacerein DRUG

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

Diacerein group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients diagnosed with osteoarthritis that prescribed Diacerein at out-patient clinic, Department of Orthopedic, King Chulalongkorn Memorial Hospital

You may qualify if:

• Osteoarthritis with
• Ocular surface index score ≥ 13 with
• Corneal staining score ≥ 3

You may not qualify if:

• Allergic to diacerein
• Use Cyclosporin within 30 days
• Eyelid problem
• Change artificial tear while in the study
• Pregnancy or breast feeding

Sponsors & Collaborators

• Chulalongkorn University: lead

Study Sites (1)

Faculty of medicine, Chulalongkorn university

Bangkok, 10330, Thailand

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

Tears within Schirmer paper

MeSH Terms

Conditions

Osteoarthritis; Dry Eye Syndromes

Interventions

diacerein

Condition Hierarchy (Ancestors)

Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Lacrimal Apparatus Diseases; Eye Diseases

Study Officials

• Ngamjit Kasetsuwan

  Department of Ophthalmology, Chulalongkorn University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate professor

Study Record Dates

• First Submitted: April 10, 2020
• First Posted: April 17, 2020
• Study Start: October 1, 2019
• Primary Completion: July 31, 2020
• Study Completion: July 31, 2020
• Last Updated: August 10, 2021

Record last verified: 2021-08

Locations

TH (1)