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Examination of the efficacy of Conheal® artificial tears in dry eye patients suffering Sjögren's syndrome

Examination of the efficacy of Conheal® glycerol and sodium hyaluronate containing artificial tears in dry eye patients suffering Sjögren's syndrome

Status
Active, not recruiting
Phases
Phase 2
Study type
Interventional
Source
ISRCTN
Registry ID
ISRCTN17717813
Enrollment
21
Registered
2017-09-24
Start date
2016-02-01
Completion date
Unknown
Last updated
2019-04-29

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

Conditions

Moderate objective and subjective dry eye symptoms as a consequence of the dry eye disease caused by Sjögren's syndrome. Eye Diseases Moderate objective and subjective dry eye symptoms as a consequence of the dry eye disease caused by Sjögren's syndrome.

Interventions

Sponsors

Semmelweis University
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1. Female and male patients older than 18 2. Lid parallel conjunctival folds (LIPCOF) degree 1 or higher) 3. Lissamine green staining of minimum grade 1 or higher on the Oxford Scheme grade 4. Decreased production of aqueous tear 5. Sjögren's syndrome

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 or eye injuries occurred within 3 months before starting the treatment

Design outcomes

Secondary

MeasureTime frame
1. Reduction of lid parallel conjunctival folds is measured using the slit lamp and the Höh classification at one and three months 2. Decrease of Ocular Surface Disease Index (OSDI) is measured using Ocular Surface Disease Index (OSDI) questionnaire score at one and three months 3. Tear production is measured using Schirmer's tests at three months

Primary

MeasureTime frame
Decrease of the eye surface (lissamine green) staining is measured using the Oxford scheme grade at 1 and 3 months of treatment.

Countries

Hungary

Outcome results

None listed

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