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

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

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

ISRCTN

Registry ID

ISRCTN81112701

Enrollment

Registered

2015-01-15

Start date

2012-08-27

Completion date

Unknown

Last updated

2023-02-20

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

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

Interventions

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

Eligibility

Sex/Gender

All

Inclusion criteria

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

Exclusion criteria

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

Design outcomes

Primary

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

Secondary

Measure	Time frame
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.	—

Countries

Hungary

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Mar 4, 2026