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Influence of Lachrymal Substitute Gels on Tear Film Thickness 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. Identifier: NCT02585453
Recruitment Status : Completed
First Posted : October 23, 2015
Last Update Posted : December 3, 2015
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 the tear film thickness and the 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 tear film thickness and corneal residence time of three different formulations of topical lubricants, in particular Thealoz Duo® Eye Drops, Hylo® Gel Eye Drops and Systane® Gel 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 and determination of tear break up time (BUT) will be performed.

Condition or disease Intervention/treatment Phase
Dry Eye Syndromes Device: Thealoz Duo Gel Device: Hylo-Gel Device: Systane Gel Drops Phase 4

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Investigator)
Primary Purpose: Basic Science
Study Start Date : April 2015
Actual Primary Completion Date : September 2015
Actual Study Completion Date : November 2015

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Tears

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

Active Comparator: Patients with dry eye syndrome 2
20 Patients with dry eye syndrome
Device: Hylo-Gel
Manufacturer: Ursapharm, Saarbrücken, Germany

Active Comparator: Patients with dry eye syndrome 3
20 Patients with dry eye syndrome
Device: Systane Gel Drops
Manufacturer: Alcon Pharma GmbH, Fort Worth, TX, USA

Primary Outcome Measures :
  1. Tear Film thickness as measured with optical coherence tomography (OCT) [ Time Frame: 360 minutes ]

Secondary Outcome Measures :
  1. Tear Break Up Time [ Time Frame: 1 month ]
  2. Schirmer 1 test [ Time Frame: 1 month ]
  3. Subjective evaluation of ocular comfort [ Time Frame: 1 month ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
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, ametropia < 6 Dpt.
  7. No administration of topical lubricants 12-24 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, neoplastic, 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 identifier (NCT number): NCT02585453

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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 Identifier: NCT02585453    
Other Study ID Numbers: LT2258-PIV-0614
First Posted: October 23, 2015    Key Record Dates
Last Update Posted: December 3, 2015
Last Verified: December 2015
Additional relevant MeSH terms:
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Keratoconjunctivitis Sicca
Dry Eye Syndromes
Pathologic Processes
Conjunctival Diseases
Eye Diseases
Corneal Diseases
Lacrimal Apparatus Diseases