Plain English Summary
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
Trial website
Contact information
Type
Scientific
Primary contact
Dr Huba Kiss
ORCID ID
http://orcid.org/0000-0002-8885-6334
Contact details
Maria str 39
Budapest
H-1085
Hungary
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
N/A
Study information
Scientific title
Examination of the efficacy of Conheal® glycerol and sodium hyaluronate containing artificial tears in dry eye patients suffering Sjögren's syndrome
Acronym
Study hypothesis
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
Semmelweis University Regional and Institutional Committee of Science and Research Ethics, 16/12/2015, ref: 265/2015
Study design
Single-centre interventional trial
Primary study design
Interventional
Secondary study design
Non randomised study
Trial setting
Hospitals
Trial type
Treatment
Patient information sheet
Not available in web format, please use the contact details below to request a patient information sheet
Condition
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
Phase
Phase II
Drug names
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 trial start date
04/01/2016
Overall trial end date
30/01/2017
Reason abandoned (if study stopped)
Eligibility
Participant 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
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
21
Participant 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
Recruitment start date
01/02/2016
Recruitment end date
24/10/2016
Locations
Countries of recruitment
Hungary
Trial participating centre
Semmelweis University
Department of Ophthalmology
Mária str. 39
Budapest
H-1085
Hungary
Funders
Funder type
Charity
Funder name
For Our Eyesight Foundation
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Planned publication of the results in PLoS one.
IPD sharing statement:
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
Intention to publish date
01/12/2017
Participant level data
Available on request
Basic results (scientific)
Publication list
Publication citations
Additional files
- ISRCTN17717813_PROTOCOL_18Sep17.pdf Uploaded 02/04/2019