Efficacy of Diacerein on Ocular Surface Disease in Degenerative Arthritis Patients

• Sponsor: Chulalongkorn University (Other)
• Overall Status: Completed
• CT.gov ID: NCT04351100
• Collaborator: (none)
• Enrollment: 34
• Location: 1
• Actual Duration (Months): 10
• Patients Per Site Per Month: 3.4

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Ocular Surface Disease; Osteoarthritis; Diacerein	Drug: Diacerein

Study Design

• Study Type: Observational
• Actual Enrollment: 34 participants
• Observational Model: Case-Only
• Time Perspective: Prospective
• Official Title: Efficacy of Diacerein on Ocular Surface Disease in Degenerative Arthritis Patients
• Actual Study Start Date: Oct 1, 2019
• Actual Primary Completion Date: Jul 31, 2020
• Actual Study Completion Date: Jul 31, 2020

Arms and Interventions

Arm	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.

Outcome Measures

Primary Outcome Measures

1. 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

1. Ocular surface disease index score [At the time of enrollment and 2 months]

   Ocular Surface Disease Index : 0-100 (0=no any symptom)

2. Tear Osmolarity [At the time of enrollment and 2 months]

   Use Tearlab to measure tear osmolarity

3. 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

4. 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

5. 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)

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Faculty of medicine, Chulalongkorn university	Bangkok		Thailand	10330

Sponsors and Collaborators

• Chulalongkorn University

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Ngamjit Kasetsuwan, Associate professor, Chulalongkorn University
• ClinicalTrials.gov Identifier: NCT04351100
• Other Study ID Numbers: IRB No. 469/62
• First Posted: Apr 17, 2020
• Last Update Posted: Aug 10, 2021
• Last Verified: Aug 1, 2021

• Individual Participant Data (IPD) Sharing Statement: Undecided
• Plan to Share IPD: Undecided
• Keywords provided by Ngamjit Kasetsuwan, Associate professor, Chulalongkorn University: Dry Eye Syndromes; Osteoarthritis; Ocular surface inflammation; Interleukin-1; Interleukin-1 receptor antagonist
• Additional relevant MeSH terms: Osteoarthritis; Diacetylrhein

Study Results

No Results Posted as of Aug 10, 2021