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
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
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