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OpenTrials
Completed

NCT Number: NCT04351100

Efficacy of Diacerein on Ocular Surface Disease in Degenerative Arthritis Patients

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.

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Key information

Conditions

Ocular Surface Disease Arthritis Diacerein Dry Eye Syndromes Eye Diseases Joint Diseases Lacrimal Apparatus Diseases Musculoskeletal Diseases Osteoarthritis Rheumatic Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Faculty of medicine, Chulalongkorn university

Bangkok, 10330, Thailand

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Diacerein

Drug

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

Primary outcomes

  1. 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)

Secondary outcomes

  1. 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)

  2. Tear Osmolarity

    Time frame: At the time of enrollment and 2 months

    Use Tearlab to measure tear osmolarity

  3. 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

  4. 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

  5. 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)

Sponsors and collaborators

Lead sponsor

Chulalongkorn University

Other

Registry information

Important dates

Study start
2019
Primary completion
2020
Study completion
2020
First posted
Apr 17, 2020
Registry last updated
Aug 10, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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