Dry Eye Syndrome
Conditions
Keywords
topical lubricants, optical coherence tomography, tear break up time, Schirmer I test
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, information about the corneal residence time of topical lubricants is still sparse, therefore no ideal treatment regimen has been found. Recently a new method for assessment of tear film thickness based on optical coherence tomography (OCT) has become available. The aim of the present study is to assess corneal residence time of three different formulations of topical lubricants, in particular Thealoz Duo® Eye Drops, Hyabak® Eye Drops and Hydrabak® Eye Drops in patients with moderate dry eye disease. In addition, standard tests for dry eye syndrome, such as the ocular surface disease index (OSDI©), Schirmer I test and determination of tear break up time (BUT) will be performed..
Sponsors
Medical University of Vienna
Study design
Allocation
RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* 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 criteria
* 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Tear film thickness | Change in tear film thickness from predose to 10 ± 3 minutes, 20 ± 3 minutes, 40 ± 5 minutes, 60 ± 5 minutes, 120 ± 10 minutes and 240 ± 10 minutes after instillation | Change in tear film thickness as measured with OCT. Total time frame is 4 hours |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Tear Break Up Time | change from screening to the last OCT measurement | Total time frame is 14 days |
| Subjective evaluation of ocular comfort | change after instillation and after the last OCT measurement | Ocular comfort will be assessed immediately after instillation and at the end of the study day. Total time frame is 4 hours. |
| Schirmer I test | change from screening to after the last OCT measurement | Total time frame is 14 days |
| Visual Acuity | change from screening to after the last OCT measurement | Total time frame is 14 days. |
| Intraocular Pressure | change from screening to after the last OCT measurement | Total time frame is 14 days |
Countries
Austria
Outcome results
None listed