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
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
Scientific
Mária str. 39.
Budapest
1085
Hungary
Study information
| Study design | Single-centre interventional trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Non randomised study |
| Study setting(s) | Hospital |
| Study type | Treatment |
| 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 |
| Study objectives | 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(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) studied | 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 |
| Pharmaceutical study type(s) | |
| Phase | Phase II |
| Drug / device / biological / vaccine name(s) | Conheal® eye drops (provided by Pannonpharma Ltd., Pécsvárad, Hungary) |
| Primary outcome measure | 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 study start date | 27/08/2012 |
| Completion date | 04/11/2013 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Both |
| Target number of participants | 20 |
| Total final enrolment | 20 |
| Key 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 |
| Key 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 |
| Date of first enrolment | 27/08/2012 |
| Date of final enrolment | 24/07/2013 |
Locations
Countries of recruitment
- Hungary
Study participating centre
Budapest
1085
Hungary
Sponsor information
University/education
Mária str. 39.
Budapest
1085
Hungary
| Website | http://semmelweis.hu/english/department-of-ophthalmology/ |
|---|---|
"ROR" |
https://ror.org/01g9ty582 |
Funders
Funder type
Not defined
No information available
Results and Publications
| Intention to publish date | 14/07/2015 |
|---|---|
| Individual participant data (IPD) Intention to share | Yes |
| IPD sharing plan summary | Available on request |
| 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. |
| IPD sharing plan | The 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.
