Dry Eye SyndromesNCT04597762
Effect of Ciclosporin Eyedrops on Sjögren Syndrome
A study testing Cyclosporin and Hydrocortisone in people with Dry Eye Syndromes, run by Hospital Hietzing at 1 site in Austria.
Trial summary
Keratoconjunctivitis sicca, also known as dry eye syndrome, is one of the most common ophthalmological diseases and is treated with tear substitutes to moisten the surface of the eye and, in more severe cases of this disease, with local anti-inflammatory therapy with corticosteroids or ciclosporin A. Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Dry Eye Syndromes
- What is being tested?
- Cyclosporin and Hydrocortisone
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12 participants
- Where
- 1 siteAustria
- Study dates
- 31 Aug 2020to 31 Mar 2021
- Phase
- Interventional
- 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 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Diagnosis of severe keratoconjunctivitis sicca defined by:
- Staining of the cornea ≥ grade III according to the Oxford scale
- OSDI value ≥ 12
- Age between 18 and 90 years
- Primary or secondary Sjogren's syndrome (defined according to the American-European Consensus Group criteria) with a stable course and unchanged treatment for 6 months
Who cannot join
- Pregnancy (excluded with a pregnancy test in patients of childbearing potential)
- Children and young people up to the age of 18
- Eye surgery in the past 6 months
- Simultaneous participation in another study
- Regular use of eye drops, with the exception of tear substitutes
- Use of eye drops containing ciclosporin or glucocorticoids in the last 6 months
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effect of Ciclosporin Eyedrops on Ocular Symptoms and Optical Quality in Patients With Sjögren Syndrome
Keratoconjunctivitis sicca, also known as dry eye syndrome, is one of the most common ophthalmological diseases and is treated with tear substitutes to moisten the surface of the eye and, in more severe cases of this disease, with local anti-inflammatory therapy with corticosteroids or ciclosporin A. In patients with rheumatological diseases, such as Sjögren's syndrome, dry eye syndrome of severe extent occurs particularly frequently, which is why topical anti-inflammatory therapy is often necessary in these patients.
Aim of this study is to evaluate the treatment of severe dry eye syndrome with topical cyclosporin eyedrops with and without topical corticosteroids at the beginning of the treatment.
- Conditions
- Dry Eye Syndromes
- Being tested
- Cyclosporin, Hydrocortisone
- Medical subject headings
- Dry Eye Syndromes
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CyclosporinDrug
Cyclosporin eyedrops
HydrocortisoneDrug
Hydrocortisone eyedrops
| Study group | Role | What they receive |
|---|---|---|
| right eye: Ciclosporin, left eye: Ciclosporin + Hydrocortisone | Experimental | Patients receive treatment with Ciclosporin eyedrops for the right eye and Ciclosporin eyedrops + Hydrocortisone eyedrops for the left eye Receives: Drug: Cyclosporin; Drug: Hydrocortisone |
| left eye: Ciclosporin, right eye: Ciclosporin + Hydrocortisone | Experimental | Patients receive treatment with Ciclosporin eyedrops for the left eye and Ciclosporin eyedrops + Hydrocortisone eyedrops for the right eye Receives: Drug: Cyclosporin; Drug: Hydrocortisone |
What is being measured
The primary outcome is the main question the study is designed to answer.
tearfilm breakup time
tearfilm breakup time measured with Fluorescein
Measured: 6 months
corneal fluorescein staining
corneal fluorescein staining staged with Oxford grading scale, ranging from 0 (no staining) to 5 (maximal staining)
Measured: 6 months
corneal optical aberrations
corneal optical aberrations measured with iTrace aberrometry
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Oct 2020
- Study start31 Aug 2020
- Primary completion30 Mar 2021
- Study completion31 Mar 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Dry Eye SyndromesStudies of the same condition, open and under way.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 12 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hospital Hietzing
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Prof. Dr. Pia Vécsei-Marlovits, Hospital Hietzing
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04597762
- Sponsor's protocol ID
- SiccaIkervis
- Status last verified
- Apr 2021
- First submitted
- 16 Oct 2020
- Last updated
- 8 Apr 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Apr 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Ciclosporin Eyedrops on Ocular Symptoms and Optical Quality in Patients With Sjögren Syndrome
- ClinicalTrials.gov ID
- NCT04597762
- Acronym / sponsor ID
- SiccaIkervis
- Conditions
- Dry Eye Syndromes
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 12 participants (actual)
- Lead sponsor
- Hospital HietzingUniversity, hospital or other
- Study start
- 31 Aug 2020 (actual)
- Primary completion
- 30 Mar 2021 (actual)
- Study completion
- 31 Mar 2021 (actual)
- First posted
- 22 Oct 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.
Keratoconjunctivitis sicca, also known as dry eye syndrome, is one of the most common ophthalmological diseases and is treated with tear substitutes to moisten the surface of the eye and, in more severe cases of this disease, with local anti-inflammatory therapy with corticosteroids or ciclosporin A. In patients with rheumatological diseases, such as Sjögren's syndrome, dry eye syndrome of severe extent occurs particularly frequently, which is why topical anti-inflammatory therapy is often necessary in these patients.
Aim of this study is to evaluate the treatment of severe dry eye syndrome with topical cyclosporin eyedrops with and without topical corticosteroids at the beginning of the treatment.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| right eye: Ciclosporin, left eye: Ciclosporin + Hydrocortisone | Experimental | Drug: Cyclosporin, Drug: HydrocortisonePatients receive treatment with Ciclosporin eyedrops for the right eye and Ciclosporin eyedrops + Hydrocortisone eyedrops for the left eye |
| left eye: Ciclosporin, right eye: Ciclosporin + Hydrocortisone | Experimental | Drug: Cyclosporin, Drug: HydrocortisonePatients receive treatment with Ciclosporin eyedrops for the left eye and Ciclosporin eyedrops + Hydrocortisone eyedrops for the right eye |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Diagnosis of severe keratoconjunctivitis sicca defined by:
- Staining of the cornea ≥ grade III according to the Oxford scale
- OSDI value ≥ 12
- Age between 18 and 90 years
- Primary or secondary Sjogren's syndrome (defined according to the American-European Consensus Group criteria) with a stable course and unchanged treatment for 6 months
Key exclusion criteria (6 listed)
- Pregnancy (excluded with a pregnancy test in patients of childbearing potential)
- Children and young people up to the age of 18
- Eye surgery in the past 6 months
- Simultaneous participation in another study
- Regular use of eye drops, with the exception of tear substitutes
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 |
|---|---|---|
| CyclosporinCyclosporin eyedrops | Drug | left eye: Ciclosporin, right eye: Ciclosporin + Hydrocortisone, right eye: Ciclosporin, left eye: Ciclosporin + Hydrocortisone |
| HydrocortisoneHydrocortisone eyedrops | Drug | left eye: Ciclosporin, right eye: Ciclosporin + Hydrocortisone, right eye: Ciclosporin, left eye: Ciclosporin + Hydrocortisone |
Primary outcome
tearfilm breakup time
Time frame: 6 months
tearfilm breakup time measured with Fluorescein
corneal fluorescein staining
Time frame: 6 months
corneal fluorescein staining staged with Oxford grading scale, ranging from 0 (no staining) to 5 (maximal staining)
corneal optical aberrations
Time frame: 6 months
corneal optical aberrations measured with iTrace aberrometry
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 8 Apr 2021.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Cyclosporin and Hydrocortisone in people with Dry Eye Syndromes, run by Hospital Hietzing at 1 site in Austria.
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 5 inclusion and 6 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 8 Apr 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 Austria. 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?
tearfilm breakup time (time frame: 6 months). The study lists 3 primary outcomes in all. 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 8 Apr 2021.