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Influence of Three Different Formulations of Lachrymal Substitutes on Tear Film Thickness and Other Signs and Symptoms in Patients With Moderate to Severe Dry Eye Syndrome

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02986750
Recruitment Status : Completed
First Posted : December 8, 2016
Last Update Posted : August 20, 2019
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. However, exact information about influence on tear film thickness and 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 ultra-high resolution optical coherence tomography (OCT) has become available. The aim of the present study is to assess the influence on tear film thickness of three different formulations of topical lubricants, in particular Thealoz Duo® Eye Drops, Optive® Eye Drops and Systane Ultra® Eye Drops in patients with moderate to severe dry eye disease. In addition, standard tests for dry eye syndrome, such as the ocular surface disease index (OSDI©), Schirmer I test, corneal fluorescein staining and determination of tear break up time (BUT) will be performed to compare the product effects.


Condition or disease Intervention/treatment Phase
Dry Eye Syndromes Device: Thealoz Duo Eye Drops Device: Optive Eye Drops Device: Systane Ultra Eye Drops Phase 4

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 120 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Investigator)
Primary Purpose: Basic Science
Actual Study Start Date : February 13, 2016
Actual Primary Completion Date : March 23, 2017
Actual Study Completion Date : March 23, 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Tears

Arm Intervention/treatment
Experimental: Experimental: Patients with dry eye syndrome 1
40 Patients with dry eye syndrome
Device: Thealoz Duo Eye Drops
Manufacturer: Laboratoires Thea, France

Active Comparator: Experimental: Patients with dry eye syndrome 2
40 Patients with dry eye syndrome
Device: Optive Eye Drops
Manufacturer: Allergan Pharmaceuticals, Ireland

Active Comparator: Experimental: Patients with dry eye syndrome 3
40 Patients with dry eye syndrome
Device: Systane Ultra Eye Drops
Manufacturer: Alcon Pharma GmbH




Primary Outcome Measures :
  1. Change in tear film thickness as measured with Optical Coherence Tomography (OCT) [ Time Frame: 10 weeks; at baseline, 10 minutes, 20 minutes, 40 minutes, 60 minutes, 120 minutes and 240 minutes after instillation of eye drops as well as 4 weeks and 8 weeks after the first instillation ]
    Tear film thickness as measured with Optical Coherence Tomography (OCT) predose and at defined time points after the first instillation, as well as on each study day


Secondary Outcome Measures :
  1. Tear Break Up Time (BUT) [ Time Frame: 10 weeks ]
  2. Subjective evaluation of ocular comfort with questionnaire [ Time Frame: 10 weeks ]
  3. Schirmer I test [ Time Frame: 10 weeks ]
  4. OSDI score [ Time Frame: 10 weeks ]
  5. Corneal fluorescein staining (Oxford grading scale) [ Time Frame: 10 weeks ]
  6. Conjunctival hyperemia score [ Time Frame: 10 weeks ]
  7. Efficacy assessment of eye drops by the patient with questionnaire [ Time Frame: 10 weeks ]

    Efficacy of eye drops will be performed by the patient by choosing one of the following options:

    • Very satisfactory
    • Satisfactory
    • Not very satisfactory
    • Unsatisfactory

  8. Efficacy assessment of eye drops by the investigator with questionnaire [ Time Frame: 10 weeks ]

    Efficacy of eye drops will be performed by the investigator by choosing one of the following options:

    • Very satisfactory
    • Satisfactory
    • Not very satisfactory
    • Unsatisfactory



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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, ametropia < 6 Dpt.
  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 study medications or Fluorescein.
  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, haematological 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 sterilised.
  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.
  12. Subject is a ward of court.

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): NCT02986750


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

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Responsible Party: Gerhard Garhofer, Assoc. Prof. PD Dr., Medical University of Vienna
ClinicalTrials.gov Identifier: NCT02986750    
Other Study ID Numbers: LT2258-PIV-0216
First Posted: December 8, 2016    Key Record Dates
Last Update Posted: August 20, 2019
Last Verified: August 2019
Additional relevant MeSH terms:
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Keratoconjunctivitis Sicca
Dry Eye Syndromes
Syndrome
Disease
Pathologic Processes
Keratoconjunctivitis
Conjunctivitis
Conjunctival Diseases
Eye Diseases
Keratitis
Corneal Diseases
Lacrimal Apparatus Diseases
Ophthalmic Solutions
Pharmaceutical Solutions