Efficacy of Diacerein on Ocular Surface Disease in Degenerative Arthritis Patients

August 9, 2021 updated by: Ngamjit Kasetsuwan, Chulalongkorn University
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

34

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Thailand
      • Bangkok, Thailand, 10330
        • Faculty of Medicine, Chulalongkorn University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

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

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Diacerein group
Osteoarthritis and dry eye patients treated with Diacerein
Drug: Diacerein
Diacerein prescribing by orthopedist. Dry eye sign and symptom was asses before start diacerein and after 2 months.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Corneal staining score change from baseline at 2 months
Time Frame: 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)
At the time of enrollment and 2 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Ocular surface disease index score
Time Frame: At the time of enrollment and 2 months
Ocular Surface Disease Index : 0-100 (0=no any symptom)
At the time of enrollment and 2 months
Tear Osmolarity
Time Frame: At the time of enrollment and 2 months
Use Tearlab to measure tear osmolarity
At the time of enrollment and 2 months
Tear break up time
Time Frame: At the time of enrollment and 2 months
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
Time Frame: At the time of enrollment and 2 months
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
Time Frame: 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)
At the time of enrollment and 2 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Chulalongkorn University

Investigators

  • Principal Investigator: Ngamjit Kasetsuwan, Department of Ophthalmology, Chulalongkorn University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 1, 2019

Primary Completion (Actual)

July 31, 2020

Study Completion (Actual)

July 31, 2020

Study Registration Dates

First Submitted

April 10, 2020

First Submitted That Met QC Criteria

April 16, 2020

First Posted (Actual)

April 17, 2020

Study Record Updates

Last Update Posted (Actual)

August 10, 2021

Last Update Submitted That Met QC Criteria

August 9, 2021

Last Verified

August 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IRB No. 469/62

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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