Examination of the efficiency of ConHeal® sodium-hyaluronate containing eye drops in conjunctival and corneal epithelial injuries

ISRCTN ISRCTN81112701
DOI https://doi.org/10.1186/ISRCTN81112701
Secondary identifying numbers N/A
Submission date
31/12/2014
Registration date
15/01/2015
Last edited
09/02/2023
Recruitment status
No longer recruiting
Overall study status
Completed
Condition category
Eye Diseases
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data

Plain English summary of protocol

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

Contact information

Dr Huba Kiss
Scientific

Mária str. 39.
Budapest
1085
Hungary

Study information

Study designSingle-centre interventional trial
Primary study designInterventional
Secondary study designNon randomised study
Study setting(s)Hospital
Study typeTreatment
Scientific titleExamination 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
Study objectivesFour 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(s)Hungarian Scientific and Research-Ethics Committee (http://www.ett.hu/tukeb.htm, tukeb@emmi.gov.hu), 07/12/2011, ref 21455-1/2011-EKU
Health condition(s) or problem(s) studiedSevere conjunctivochalasis, characterized by high LIPCOF degree, as both a reason and consequence of the dry eye disease.
InterventionPatients 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 typeDrug
Pharmaceutical study type(s)
PhasePhase II
Drug / device / biological / vaccine name(s)Conheal® eye drops (provided by Pannonpharma Ltd., Pécsvárad, Hungary)
Primary outcome measureDecrease in LId-Parallel COnjunctival Folds (LIPCOF) degree characterizing severe conjunctivochalasis after 1 and 3 months of treatment.
Secondary outcome measures1. 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 study start date27/08/2012
Completion date04/11/2013

Eligibility

Participant type(s)Patient
Age groupAdult
Lower age limit18 Years
SexBoth
Target number of participants20
Total final enrolment20
Key inclusion criteria1. 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
Key exclusion criteria1. 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
Date of first enrolment27/08/2012
Date of final enrolment24/07/2013

Locations

Countries of recruitment

  • Hungary

Study participating centre

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

Sponsor information

Semmelweis University, Department of Ophthalmology
University/education

Funders

Funder type

Not defined

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

No information available

Results and Publications

Intention to publish date14/07/2015
Individual participant data (IPD) Intention to shareYes
IPD sharing plan summaryAvailable on request
Publication and dissemination planPreliminary 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.
IPD sharing planThe datasets generated during and/or analysed during the current study are/will be available upon request

Study outputs

Output type Details Date created Date added Peer reviewed? Patient-facing?
Results article results 14/07/2015 Yes No
Protocol (other) 09/02/2023 No No

Editorial Notes

09/02/2023: Protocol and total final enrolment added.