Clinical trial NCT02980913: Difference in the Frequency of Use of Lachrymal Substitutes in Patients With Moderate to Severe Dry Eye Syndrome
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Dry Eye Syndromes
Lead sponsor: Medical University of Vienna
Sponsor class: OTHER
First posted: 2016-12-02
Enrollment: 45
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: BASIC_SCIENCE

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.


Eligibility criteria: 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, neoplasic, 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.

Primary outcomes:
measure: Number of drops of Thealoz Duo® eye drops and Thealoz Duo® gel instilled during the day (patient diary)
timeFrame: 4 weeks
Secondary outcomes:
measure: Tear Break Up Time (BUT)
timeFrame: 4 weeks
measure: Schirmer I test
timeFrame: 4 weeks
measure: Conjunctival and corneal staining
timeFrame: 4 weeks
measure: OSDI questionnaire
timeFrame: 4 weeks
measure: Quality of life of patients (VAS)
timeFrame: 4 weeks
Other outcomes:
Locations:
city: Vienna
country: Austria
facility: Department of Clinical Pharmacology, Medical University of Vienna
Study officials:
References:
citation: Fondi K, Wozniak PA, Schmidl D, Bata AM, Witkowska KJ, Popa-Cherecheanu A, Schmetterer L, Garhofer G. Effect of Hyaluronic Acid/Trehalose in Two Different Formulations on Signs and Symptoms in Patients with Moderate to Severe Dry Eye Disease. J Ophthalmol. 2018 Aug 1;2018:4691417. doi: 10.1155/2018/4691417. eCollection 2018.