Dry Eye Syndromes
Conditions
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. Relief of symptoms in patients with moderate to severe dry eye disease is usually reached by the use of artificial tears during the day. Nighttime relief is often achieved by substances known to be more adhesive to the ocular surface, such as gels.
Interventions
DEVICEThealoz Duo Gel and Thealoz Duo eye drops
Thealoz Duo gel at night (1 drop before going to bed) + Thealoz Duo eye drops during the day (4 to 6 drops per day)
DEVICEThealoz Duo eye drops
Thealoz Duo eye drops during the day (4 to 6 drops per day)
Sponsors
Medical University of Vienna
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
BASIC_SCIENCE
Masking
SINGLE (Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Men and women aged over 18 years 2. Signed and dated written informed consent. 3. History of dry eye syndrome for at least 3 months 4. Tear Break Up Time (BUT) ≤ 10 seconds or Schirmer I test ≤ 5 mm and ≥ 2mm 5. OSDI ≥ 22 6. Normal ophthalmic findings except dry eye syndrome 7. No administration of topical lubricants 24 hours before the screening examination
Exclusion criteria
1. Presence of an ocular pathology judged by the investigator as incompatible with the study. 2. Any other clinical relevant ocular abnormality except DES. 3. History of allergy, known hypersensitivity to one of the components: the administered medical device product, fluorescein or lissamine green 4. History of known clinically relevant allergy 5. Medical or surgical history judged by the investigator to be incompatible with the study participation (hepatic or renal insufficiency; all chronic severe organic disease: metabolic, endocrine, neoplastic, hematological disease; severe psychiatric illness, etc.). 6. History of a recent acute illness with a recovery period within the 2 weeks before the inclusion visit (Day 0). 7. Pregnancy, lactation. 8. Pre-menopausal woman who is not using a reliable birth control method (oral contraceptives or coil) or is not surgically sterilized. 9. Participation in any high-speed or water-sports during the study without ocular protection (goggles or glasses). 10. Subject unable to understand the study instructions or unlikely to comply with the study schedule and treatment. 11. Participation in another clinical study in the 4 weeks before the start of the present study or at the same time as the present study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Patient satisfaction when awakening (VAS) | 4 weeks |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of drops of Thealoz Duo instilled during the day (patient diary) | 4 weeks | — |
| Tear break up time | 4 weeks | — |
| Quality of life | 4 weeks | — |
| Schirmer 1 Test | 4 weeks | — |
| OSDI questionnaire | 4 weeks | Ocular Surface Disease Index Questionnaire |
| Conjunctival and corneal staining | 4 weeks | — |
Countries
Austria
Outcome results
None listed