Condition category
Eye Diseases
Date applied
28/08/2017
Date assigned
24/09/2017
Last edited
18/09/2017
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

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 measures

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

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

Sponsor information

Organisation

Semmelweis University

Sponsor details

Department of Ophthalmology
Maria str. 39
Budapest
H-1085
Hungary

Sponsor type

Not defined

Website

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

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes