Condition category
Eye Diseases
Date applied
31/12/2014
Date assigned
15/01/2015
Last edited
23/07/2015
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. Conjunctivochalasis is a common dry eye disorder, which can cause an unstable tear film and ocular discomfort. It is characterised by excess folds of the conjunctiva between the glove of the eye and the eyelid margin and it usually requires surgery, although a conservative therapy would be highly desirable.
The aim of the study is to assess whether a preservative-free, inorganic salt-free unit-dose artificial tear, called Conheal®, can improve vision-related quality of life, even in the case of severe conjunctivochalasis which would traditionally require surgery.

Who can participate?
Adult patients with severe conjunctivochalasis.

What does the study involve?
Patients are given Conheal® eye drops four times a day for 3 months.

What are the possible benefits and risks of participating?
Not provided at time of registration.

Where is the study run from?
Department of Ophthalmology, Semmelweis University, Hungary

When is the study starting and how long is it expected to run for?
From August 2012 to November 2013

Who is funding the study?
"Four our Eyesight" Foundation (Budapest, Hungary).

Who is the main contact?
Dr Huba Kiss

Trial website

Contact information

Type

Scientific

Primary contact

Dr Huba Kiss

ORCID ID

Contact details

Mária str. 39.
Budapest
1085
Hungary

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

N/A

Study information

Scientific title

Examination of the efficiency of ConHeal® sodium-hyaluronate containing eye drops in conjunctival and corneal epithelial injuries on patients with severe conjunctivochalasis measured by the LId-Parallel COnjunctival Folds (LIPCOF) degree, tear film breakup time, corneal lissamine green staining and Ocular Surface Disease Index (OSDI) questionnaire score

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 the LId-Parallel COnjunctival Folds (LIPCOF) degree characterizing severe conjunctivochalasis; increases tear film breakup time; reduces corneal lissamine green staining and decreases Ocular Surface Disease Index (OSDI) questionnaire score after 1 and 3 months of treatment.

Ethics approval

Hungarian Scientific and Research-Ethics Committee (http://www.ett.hu/tukeb.htm, tukeb@emmi.gov.hu), 07/12/2011, ref 21455-1/2011-EKU

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

Condition

Severe conjunctivochalasis, characterized by high LIPCOF degree, as both a reason and consequence of the dry eye disease.

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

Intervention type

Drug

Phase

Phase II

Drug names

Conheal® eye drops (provided by Pannonpharma Ltd., Pécsvárad, Hungary)

Primary outcome measures

Decrease in LId-Parallel COnjunctival Folds (LIPCOF) degree characterizing severe conjunctivochalasis after 1 and 3 months of treatment.

Secondary outcome measures

1. Increase in tear film breakup time, reduction of corneal lissamine green staining, decrease of Ocular Surface Disease Index (OSDI) questionnaire score after 1 and 3 months of treatment.

Overall trial start date

27/08/2012

Overall trial end date

04/11/2013

Reason abandoned

Eligibility

Participant inclusion criteria

1. Female and male patients older than 18
2. Severe conjunctivochalasis (having LId-Parallel COnjunctival Folds, LIPCOF degree 2 or higher)
3. Lissamine green staining of minimum grade 1 or higher on the Oxford Scheme grade, indicating a more advanced dry eye disease

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

20

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
7. Eye injuries occurred within 3 months before starting the treatment

Recruitment start date

27/08/2012

Recruitment end date

24/07/2013

Locations

Countries of recruitment

Hungary

Trial participating centre

Department of Ophthalmology, Semmelweis University
Mária str. 39
Budapest
1085
Hungary

Sponsor information

Organisation

Semmelweis University, Department of Ophthalmology

Sponsor details

Mária str. 39.
Budapest
1085
Hungary

Sponsor type

University/education

Website

http://semmelweis.hu/english/department-of-ophthalmology/

Funders

Funder type

Not defined

Funder name

"Four our Eyesight" Foundation (Budapest, Hungary).

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Preliminary data of the 1 month treatment were published in the Hungarian scientific journal Szemészet (Ophthalmology in Hungarian) https://www.researchgate.net/publication/262485247_Examination_of_conservative_treatment_possibility_of_conjunctivochalasis__A_preliminary_report.
Full data of the 3-month study were published in PLoS ONE: http://journals.plos.org/plosone/article?id=10.1371/journal.pone.0132656.

Intention to publish date

14/07/2015

Participant level data

Available on request

Results - basic reporting

Publication summary

2015 results in: http://www.ncbi.nlm.nih.gov/pubmed/26172053

Publication citations

Additional files

Editorial Notes