Ocular Surface DiseaseNCT04351100
Efficacy of Diacerein on Ocular Surface Disease in Degenerative Arthritis Patients
An observational study of Ocular Surface Disease and Osteoarthritis, run by Chulalongkorn University at 1 site in Thailand.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Ocular Surface Disease, Osteoarthritis, Diacerein
- What is being tested?
- Diacerein
- How many people
- 34 participants
- Where
- 1 siteThailand
- Study dates
- 1 Oct 2019to 31 Jul 2020
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients diagnosed with osteoarthritis that prescribed Diacerein at out-patient clinic, Department of Orthopedic, King Chulalongkorn Memorial Hospital
Who may be able to join
- Osteoarthritis with
- Ocular surface index score ≥ 13 with
- Corneal staining score ≥ 3
Who cannot join
- Allergic to diacerein
- Use Cyclosporin within 30 days
- Eyelid problem
- Change artificial tear while in the study
- Pregnancy or breast feeding
Trial locations and contacts
1 site in 1 country.
About this study
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
- Being tested
- Diacerein
- Keywords
- Dry Eye Syndromes, Osteoarthritis, Ocular surface inflammation, Interleukin-1, Interleukin-1 receptor antagonist
- Medical subject headings
- Osteoarthritis, Dry Eye Syndromes
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DiacereinDrug
Diacerein prescribing by orthopedist. Dry eye sign and symptom was asses before start diacerein and after 2 months.
| Study group | Role | What they receive |
|---|---|---|
| Diacerein group | Osteoarthritis and dry eye patients treated with Diacerein Receives: Drug: Diacerein |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: At the time of enrollment and 2 months
Secondary outcomes (5)
Ocular surface disease index score
Ocular Surface Disease Index : 0-100 (0=no any symptom)
Measured: At the time of enrollment and 2 months
Tear Osmolarity
Use Tearlab to measure tear osmolarity
Measured: At the time of enrollment and 2 months
Tear break up time
Stain Cornea with Fluorescine, wait until tear film break, record time that tear break
Measured: At the time of enrollment and 2 months
Schirmer 1 test
place Schirmer strip at the fornix without anesthesia, wait for 5 min, record tear distance
Measured: At the time of enrollment and 2 months
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)
Measured: At the time of enrollment and 2 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Apr 2020
- Study start1 Oct 2019
- Primary completion31 Jul 2020
- Study completion31 Jul 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ocular Surface DiseaseStudies of the same condition, open and under way.
- More trials run by Chulalongkorn UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 34 participants (actual)
Sponsor and investigators
- Lead sponsor
- Chulalongkorn University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ngamjit Kasetsuwan, Chulalongkorn University
- Investigators
- Ngamjit Kasetsuwan, Principal investigator, Department of Ophthalmology, Chulalongkorn University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04351100
- Sponsor's protocol ID
- IRB No. 469/62
- Status last verified
- Aug 2021
- First submitted
- 10 Apr 2020
- Last updated
- 10 Aug 2021
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 10 Aug 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of Diacerein on Ocular Surface Disease in Degenerative Arthritis Patients
- ClinicalTrials.gov ID
- NCT04351100
- Acronym / sponsor ID
- IRB No. 469/62
- Conditions
- Ocular Surface Disease, Osteoarthritis, Diacerein
- Keywords
- Dry Eye Syndromes, Osteoarthritis, Ocular surface inflammation, Interleukin-1, Interleukin-1 receptor antagonist
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 34 participants (actual)
- Lead sponsor
- Chulalongkorn UniversityUniversity, hospital or other
- Study start
- 1 Oct 2019 (actual)
- Primary completion
- 31 Jul 2020 (actual)
- Study completion
- 31 Jul 2020 (actual)
- First posted
- 17 Apr 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Diacerein group | – | Drug: DiacereinOsteoarthritis and dry eye patients treated with Diacerein |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients diagnosed with osteoarthritis that prescribed Diacerein at out-patient clinic, Department of Orthopedic, King Chulalongkorn Memorial Hospital
Key inclusion criteria (3 listed)
- Osteoarthritis with
- Ocular surface index score ≥ 13 with
- Corneal staining score ≥ 3
Key exclusion criteria (5 listed)
- Allergic to diacerein
- Use Cyclosporin within 30 days
- Eyelid problem
- Change artificial tear while in the study
- Pregnancy or breast feeding
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| DiacereinDiacerein prescribing by orthopedist. Dry eye sign and symptom was asses before start diacerein and after 2 months. | Drug | Diacerein group |
Primary outcome
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)
5 secondary outcomes
Ocular surface disease index score
Time frame: At the time of enrollment and 2 months
Tear Osmolarity
Time frame: At the time of enrollment and 2 months
Tear break up time
Time frame: At the time of enrollment and 2 months
Schirmer 1 test
Time frame: 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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Aug 2021.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ngamjit Kasetsuwan principal investigator
Department of Ophthalmology, Chulalongkorn University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Ocular Surface Disease and Osteoarthritis, run by Chulalongkorn University at 1 site in Thailand.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 10 Aug 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Thailand. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Corneal staining score change from baseline at 2 months (time frame: At the time of enrollment and 2 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Aug 2021.