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Difference in the Frequency of Use of Lachrymal Substitutes in Patients With Moderate to Severe Dry Eye Syndrome

Sponsor
Medical University of Vienna (Other)
Overall Status
Completed
CT.gov ID
NCT02980913
Collaborator
(none)
45
Enrollment
1
Location
2
Arms
3.2
Actual Duration (Months)
14.3
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Device: Thealoz Duo eye drops and Thealoz Duo gel
  • Device: Thealoz Duo gel
 N/A

Study Design

Study Type:
Interventional
Actual Enrollment :
45 participants
Allocation:
Randomized
Intervention Model:
Crossover Assignment
Masking:
Single (Investigator)
Primary Purpose:
Basic Science
Actual Study Start Date :
Feb 11, 2016
Actual Primary Completion Date :
May 17, 2016
Actual Study Completion Date :
May 17, 2016

Arms and Interventions

Arm Intervention/Treatment
Experimental: Experimental: Patients with dry eye syndrome 1

20 patients with dry eye syndrome, they will receive intervention 1 for one week and then cross over to intervention 2

Device: Thealoz Duo eye drops and Thealoz Duo gel
Thealoz Duo eye drops during the day + Thealoz Duo gel at night (1 drop before going to bed) for 7 days
Other Names:
  • Intervention 1

    • Device: Thealoz Duo gel
    Thealoz Duo gel during the day and at night for 7 days
    Other Names:
  • Intervention 2

    		•
    Experimental: Experimental: Patients with dry eye syndrome 2

    20 patients with dry eye syndrome, they will receive intervention 2 for one week and then cross over to intervention 1

    Device: Thealoz Duo eye drops and Thealoz Duo gel
    Thealoz Duo eye drops during the day + Thealoz Duo gel at night (1 drop before going to bed) for 7 days
    Other Names:
  • Intervention 1

    • Device: Thealoz Duo gel
    Thealoz Duo gel during the day and at night for 7 days
    Other Names:
  • Intervention 2

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Number of drops of Thealoz Duo® eye drops and Thealoz Duo® gel instilled during the day (patient diary) [4 weeks]

      Number of drops of Thealoz Duo® eye drops and Thealoz Duo® gel instilled during the day during the observation period of one week for each medical device (patient diary)

    Secondary Outcome Measures

    1. Tear Break Up Time (BUT) [4 weeks]

    2. Schirmer I test [4 weeks]

    3. Conjunctival and corneal staining [4 weeks]

    4. OSDI questionnaire [4 weeks]

    5. Quality of life of patients (VAS) [4 weeks]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts 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, 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.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Department of Clinical Pharmacology, Medical University of Vienna Vienna Austria 1090

    Sponsors and Collaborators

    • Medical University of Vienna

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Gerhard Garhofer, Assoc. Prof. PD Dr., Medical University of Vienna
    ClinicalTrials.gov Identifier:
    NCT02980913
    Other Study ID Numbers:
    • LT 2258-PIV-05/15
    First Posted:
    Dec 2, 2016
    Last Update Posted:
    Aug 22, 2019
    Last Verified:
    Aug 1, 2019
    Additional relevant MeSH terms:
    Dry Eye Syndromes
    Keratoconjunctivitis Sicca
    Syndrome
    Ophthalmic Solutions

    Study Results

    No Results Posted as of Aug 22, 2019