- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02986750
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
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
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Actual)
Phase
- Phase 4
Contacts and Locations
Study Locations
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-
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Vienna, Austria, 1090
- Department of Clinical Pharmacology, Medical University of Vienna
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Men and women aged over 18 years
- Signed and dated written informed consent
- History of dry eye syndrome for at least 3 months
- Tear Break Up Time (BUT) ≤ 10 seconds or Schirmer I test ≤ 5 mm and ≥ 2mm
- OSDI ≥ 22
- Normal ophthalmic findings except dry eye syndrome, ametropia < 6 Dpt.
- No administration of topical lubricants 24 hours before the screening examination
Exclusion Criteria:
- Presence of an ocular pathology judged by the investigator as incompatible with the study.
- Any other clinical relevant ocular abnormality except DES.
- History of allergy, known hypersensitivity to one of the components: the study medications or Fluorescein.
- History of known clinically relevant allergy.
- 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.).
- History of a recent acute illness with a recovery period within the 2 weeks before the inclusion visit (Day 0).
- Pregnancy, lactation.
- Pre-menopausal woman who is not using a reliable birth control method (oral contraceptives or coil) or is not surgically sterilised.
- Participation in any high-speed or water-sports during the study without ocular protection (goggles or glasses).
- Subject unable to understand the study instructions or unlikely to comply with the study schedule and treatment.
- 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.
- Subject is a ward of court.
Study Plan
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
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Manufacturer: Laboratoires Thea, France
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Active Comparator: Experimental: Patients with dry eye syndrome 2
40 Patients with dry eye syndrome
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Manufacturer: Allergan Pharmaceuticals, Ireland
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Active Comparator: Experimental: Patients with dry eye syndrome 3
40 Patients with dry eye syndrome
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Manufacturer: Alcon Pharma GmbH
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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
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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
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10 weeks
|
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Subjective evaluation of ocular comfort with questionnaire
Time Frame: 10 weeks
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10 weeks
|
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Schirmer I test
Time Frame: 10 weeks
|
10 weeks
|
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OSDI score
Time Frame: 10 weeks
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10 weeks
|
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Corneal fluorescein staining (Oxford grading scale)
Time Frame: 10 weeks
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10 weeks
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Conjunctival hyperemia score
Time Frame: 10 weeks
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10 weeks
|
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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:
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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:
|
10 weeks
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- LT2258-PIV-0216
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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