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

August 19, 2019 updated by: Gerhard Garhofer, Medical University of Vienna

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.

Study Overview

Study Type

Interventional

Enrollment (Actual)

120

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

      • Vienna, Austria, 1090
        • Department of Clinical Pharmacology, Medical University of Vienna

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Basic Science
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Experimental: Patients with dry eye syndrome 1
40 Patients with dry eye syndrome
Manufacturer: Laboratoires Thea, France
Active Comparator: Experimental: Patients with dry eye syndrome 2
40 Patients with dry eye syndrome
Manufacturer: Allergan Pharmaceuticals, Ireland
Active Comparator: Experimental: Patients with dry eye syndrome 3
40 Patients with dry eye syndrome
Manufacturer: Alcon Pharma GmbH

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
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

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Tear Break Up Time (BUT)
Time Frame: 10 weeks
10 weeks
Subjective evaluation of ocular comfort with questionnaire
Time Frame: 10 weeks
10 weeks
Schirmer I test
Time Frame: 10 weeks
10 weeks
OSDI score
Time Frame: 10 weeks
10 weeks
Corneal fluorescein staining (Oxford grading scale)
Time Frame: 10 weeks
10 weeks
Conjunctival hyperemia score
Time Frame: 10 weeks
10 weeks
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
10 weeks
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
10 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 13, 2016

Primary Completion (Actual)

March 23, 2017

Study Completion (Actual)

March 23, 2017

Study Registration Dates

First Submitted

December 1, 2016

First Submitted That Met QC Criteria

December 5, 2016

First Posted (Estimate)

December 8, 2016

Study Record Updates

Last Update Posted (Actual)

August 20, 2019

Last Update Submitted That Met QC Criteria

August 19, 2019

Last Verified

August 1, 2019

More Information

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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