Examination of the efficacy of Conheal® artificial tears in dry eye patients suffering Sjögren's syndrome
| ISRCTN | ISRCTN17717813 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN17717813 |
| Secondary identifying numbers | N/A |
- Submission date
- 28/08/2017
- Registration date
- 24/09/2017
- Last edited
- 02/04/2019
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Eye Diseases
Plain English summary of protocol
Background and study aims
Dry eye complaints are one of the top reasons for visiting ophthalmologists. 12% of the aqueous (water) deficient patients are diagnosed with Sjögren's syndrome, which may cause moderate to severe objective end subjective dry eye symptoms. The aim of the study is to assess whether a preservative-free, inorganic salt-free unit-dose artificial tear, called Conheal® that contains isotonic glycerol and 0.015% hyaluronic acid, can improve vision-related quality of life among dry eye patients suffering Sjögren's syndrome.
Who can participate?
Adults aged 18 and older who have Sjögren's syndrome.
What does the study involve?
Participants are asked to use the Conheal® artificial tears 4 times a day for three months. After one and three months of treatment participants undergo ophthalmologic tests and undergo assessment of the subjective symptoms through completing a questionnaire.
What are the possible benefits and risks of participating?
Participants may benefit from improvements in their symptoms. There are no anticipated risks as Conheal® drop was proven safe in former studies.
Where is the study run from?
Semmelweis University (Hungary)
When is the study starting and how long is it expected to run for?
January 2016 to December 2017
Who is funding the study?
For Our Eyesight Foundation (EU)
Who is the main contact?
Dr Huba Kiss
kisshuba@gmail.com
Contact information
Scientific
Maria str 39
Budapest
H-1085
Hungary
 ORCID ID |
0000-0002-8885-6334 |
|---|
Study information
| Study design | Single-centre interventional trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Non randomised study |
| Study setting(s) | Hospital |
| Study type | Treatment |
| Participant information sheet | Not available in web format, please use the contact details below to request a patient information sheet |
| Scientific title | Examination of the efficacy of Conheal® glycerol and sodium hyaluronate containing artificial tears in dry eye patients suffering Sjögren's syndrome |
| Study objectives | Four times a day application of the artificial tear drops, Conheal® (provided by Pannonpharma Ltd., Pécsvárad, Hungary), containing isotonic glycerol and 0.015% hyaluronic acid in purified water for 1 and 3 months decreases improves the objective and subjective dry eye symptoms in patients suffering Sjögren's syndrome after one and three months of treatment. |
| Ethics approval(s) | Semmelweis University Regional and Institutional Committee of Science and Research Ethics, 16/12/2015, ref: 265/2015 |
| Health condition(s) or problem(s) studied | Moderate objective and subjective dry eye symptoms as a consequence of the dry eye disease caused by Sjögren's syndrome. |
| Intervention | Patients receive the artificial tear drops, Conheal® (provided by Pannonpharma Ltd., Pécsvárad, Hungary), four times a day for 3 months. The drops contain isotonic glycerol and 0.015% hyaluronic acid in purified water. There was only one active treatment arm with the study drug. Participants are followed up at one and three months with ophthalmologic tests are performed and symptoms are assessed using a questionnaire. |
| Intervention type | Drug |
| Pharmaceutical study type(s) | |
| Phase | Phase II |
| Drug / device / biological / vaccine name(s) | Conheal® eye drops (provided by Pannonpharma Ltd., Pécsvárad, Hungary) |
| Primary outcome measure | Decrease of the eye surface (lissamine green) staining is measured using the Oxford scheme grade at 1 and 3 months of treatment. |
| Secondary outcome measures | 1. Reduction of lid parallel conjunctival folds is measured using the slit lamp and the Höh classification at one and three months 2. Decrease of Ocular Surface Disease Index (OSDI) is measured using Ocular Surface Disease Index (OSDI) questionnaire score at one and three months 3. Tear production is measured using Schirmer's tests at three months |
| Overall study start date | 04/01/2016 |
| Completion date | 30/01/2017 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Both |
| Target number of participants | 21 |
| Key inclusion criteria | 1. Female and male patients older than 18 2. Lid parallel conjunctival folds (LIPCOF) degree 1 or higher) 3. Lissamine green staining of minimum grade 1 or higher on the Oxford Scheme grade 4. Decreased production of aqueous tear 5. Sjögren's syndrome |
| Key exclusion criteria | 1. Pregnancy or lactation 2. Pterygium 3. Prolonged treatment with eye drops with the exception of artificial tears 4. Active allergic keratoconjunctivitis 5. Current keratitis or conjunctivitis of infectious origin 6. Surgery affecting the eye surface or eye injuries occurred within 3 months before starting the treatment |
| Date of first enrolment | 01/02/2016 |
| Date of final enrolment | 24/10/2016 |
Locations
Countries of recruitment
- Hungary
Study participating centre
Mária str. 39
Budapest
H-1085
Hungary
Sponsor information
Not defined
Department of Ophthalmology
Maria str. 39
Budapest
H-1085
Hungary
"ROR" |
https://ror.org/01g9ty582 |
|---|
Funders
Funder type
Charity
No information available
Results and Publications
| Intention to publish date | 01/12/2017 |
|---|---|
| Individual participant data (IPD) Intention to share | Yes |
| IPD sharing plan summary | Available on request |
| Publication and dissemination plan | Planned publication of the results in PLoS one. |
| IPD sharing plan | The datasets generated during and/or analysed during the current study are/will be available upon request from Dr Huba Kiss at kisshuba@gmail.com |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Protocol file | 18/09/2017 | 02/04/2019 | No | No |
Additional files
- ISRCTN17717813_PROTOCOL_18Sep17.pdf
- Uploaded 02/04/2019
Editorial Notes
02/04/2019: Uploaded protocol (not peer reviewed).
