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

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ClinicalTrials.gov Identifier: NCT02980913
Recruitment Status : Active, not recruiting
First Posted : December 2, 2016
Last Update Posted : December 29, 2017
Sponsor:
Information provided by (Responsible Party):
Gerhard Garhofer, Medical University of Vienna

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
Dry Eye Syndromes Device: Thealoz Duo eye drops and Thealoz Duo gel Device: Thealoz Duo gel Not Applicable

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 45 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Single (Investigator)
Primary Purpose: Basic Science
Actual Study Start Date : February 11, 2016
Actual Primary Completion Date : May 17, 2016
Estimated Study Completion Date : July 2018

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 Name: Intervention 1

Device: Thealoz Duo gel
Thealoz Duo gel during the day and at night for 7 days
Other Name: 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 Name: Intervention 1

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




Primary Outcome Measures :
  1. Number of drops of Thealoz Duo® eye drops and Thealoz Duo® gel instilled during the day (patient diary) [ Time Frame: 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) [ Time Frame: 4 weeks ]
  2. Schirmer I test [ Time Frame: 4 weeks ]
  3. Conjunctival and corneal staining [ Time Frame: 4 weeks ]
  4. OSDI questionnaire [ Time Frame: 4 weeks ]
  5. Quality of life of patients (VAS) [ Time Frame: 4 weeks ]


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02980913


Locations
Austria
Department of Clinical Pharmacology, Medical University of Vienna
Vienna, Austria, 1090
Sponsors and Collaborators
Medical University of Vienna

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Gerhard Garhofer, Assoc. Prof. PD Dr., Medical University of Vienna
ClinicalTrials.gov Identifier: NCT02980913     History of Changes
Other Study ID Numbers: LT 2258-PIV-05/15
First Posted: December 2, 2016    Key Record Dates
Last Update Posted: December 29, 2017
Last Verified: December 2017

Additional relevant MeSH terms:
Syndrome
Keratoconjunctivitis Sicca
Dry Eye Syndromes
Disease
Pathologic Processes
Keratoconjunctivitis
Conjunctivitis
Conjunctival Diseases
Eye Diseases
Keratitis
Corneal Diseases
Lacrimal Apparatus Diseases
Ophthalmic Solutions
Pharmaceutical Solutions