Examination of the efficacy of Conheal® artificial tears in dry eye patients suffering Sjögren's syndrome
Phase 2
Completed
- Conditions
- Moderate objective and subjective dry eye symptoms as a consequence of the dry eye disease caused by Sjögren's syndrome.Eye Diseases
- Registration Number
- ISRCTN17717813
- Lead Sponsor
- Semmelweis University
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- All
- Target Recruitment
- 21
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
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
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Decrease of the eye surface (lissamine green) staining is measured using the Oxford scheme grade at 1 and 3 months of treatment.
- Secondary Outcome Measures
Name Time Method <br> 1. Reduction of lid parallel conjunctival folds is measured using the slit lamp and the Höh classification at one and three months<br> 2. Decrease of Ocular Surface Disease Index (OSDI) is measured using Ocular Surface Disease Index (OSDI) questionnaire score at one and three months<br> 3. Tear production is measured using Schirmer's tests at three months<br>