Status:
COMPLETED
Influence of Lachrymal Substitutes on Tear Film Thickness in Patients With Moderate Dry Eye Syndrome
Lead Sponsor:
Medical University of Vienna
Conditions:
Dry Eye Syndrome
Eligibility:
All Genders
18+ years
Phase:
PHASE4
Brief Summary
Dry eye syndrome is a highly prevalent ocular disease with an increasing incidence in the elderly population. Topically administered lubricants are the basis for treatment of this disease. However, in...
Eligibility Criteria
Inclusion
- Men and women aged over 18 years
- Signed and dated written informed consent.
- History of dry eye syndrome for at least 3 months
- Tear Break Up Time (BUT) ≤ 10 seconds or Schirmer I test ≤ 5 mm and ≥ 2mm
- OSDI (Ocular Surface Disease Index) ≤ 32 and ≥ 13
- Normal ophthalmic findings except dry eye syndrome, ametropia \< 6 Dpt.
- No administration of topical lubricants 24 hours before the screening examination
Exclusion
- Participation in a clinical trial in the 3 weeks preceding the study
- Symptoms of a clinically relevant illness in the 3 weeks before the first study day
- Presence or history of a severe medical condition as judged by the clinical investigator
- Intake of parasympathomimetic or anti-psychotic drugs
- Wearing of contact lenses
- Glaucoma
- Treatment with corticosteroids in the 4 weeks preceding the study
- Topical treatment with any ophthalmic drug except topical lubricants in the 4 weeks preceding the study
- Ocular infection or clinically significant inflammation
- Ocular surgery in the 3 months preceding the study
- Sjögren's syndrome
- Stevens-Johnson syndrome
- History of allergic conjunctivitis
- Ametropia \>= 6 Dpt
- Pregnancy, planned pregnancy or lactating
- Known hypersensitivity to any component of the study medication.
- Any medical or surgical history, disorder or disease such as acute or chronic severe organic disease
- Inability to understand the study procedures
Key Trial Info
Start Date :
May 1 2013
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 1 2013
Estimated Enrollment :
60 Patients enrolled
Trial Details
Trial ID
NCT01864330
Start Date
May 1 2013
End Date
September 1 2013
Last Update
November 27 2013
Active Locations (1)
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1
Department of Clinical Pharmacology
Vienna, Vienna, Austria, 1090