Back to resultsEffect of Single Instillation of Three Different Topical Lubricants on Tear Film Thickness in Patients With Dry Eye Syndrome
Primary Purpose
Dry Eye Syndromes
Status
Completed
Phase
Not Applicable
Locations
Austria
Study Type
Interventional
Intervention
Neovis Total Multi® Eye Drops
Vismed Multi® Eye Drops
Hydrabak® Eye Drops
Sponsored by
About this trial
This is an interventional basic science trial for Dry Eye Syndromes
Eligibility Criteria
Inclusion Criteria
Patients will be eligible for inclusion if all these criteria are respected:
- Age of at least 18 years
- Provides written informed consent prior to study-related procedures at the screening visit
- Is able to understand and willing to comply with the procedures and the actions asked of him/her
- History of dry eye syndrome for at least 3 months
- Reports at least 2 of the following symptoms related to dry eye syndrome: foreign body sensation, pain, itching, stinging, epiphora, photophobia or blurred vision
- Tear Break Up Time (BUT) ≤ 10 seconds or Schirmer I test ≤ 10 mm
- OSDI score ≥ 23 points
- Normal ophthalmic findings except dry eye syndrome
Exclusion Criteria
Patients will be excluded under the following circumstances:
- Participation in a clinical trial in the 3 weeks preceding the study
- Symptoms of a clinically relevant illness in the 3 weeks before the first study day
- Presence or history of a severe medical condition as judged by the clinical investigator
- Intake of parasympathomimetic or anti-psychotic drugs
- Wearing of contact lenses
- Glaucoma in the medical history
- Treatment with corticosteroids in the 4 weeks preceding the study
- Topical treatment with any ophthalmic drug except topical lubricants in the 4 weeks preceding the study
- Ocular infection or clinically significant inflammation not related to dry eye syndrome
- Ocular surgery in the 3 months preceding the study
- Sjögren's syndrome
- Stevens-Johnson syndrome
- History of allergic conjunctivitis
- Pregnancy, planned pregnancy or lactating
- Known hypersensitivity to any component of the study medication
Sites / Locations
- Department of Clinical Pharmacology, Medical University of Vienna
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Experimental
Experimental
Arm Label
Dry Eye Neovis
Dry Eye Vismed
Dry Eye Hydrabak
Arm Description
20 Patients with dry eye syndrome receiving Neovis Total Multi Eyedrops
20 Patients with dry eye syndrome receiving Vismed Multi Eyedrops
20 Patients with dry eye syndrome receiving Hydrabak Eyedrops
Outcomes
Primary Outcome Measures
Change in tear film thickness
Change in tear film thickness measured with optical coherence tomography (OCT) at predose and at defined time points after instillation of eyedrops
Secondary Outcome Measures
Change in lipid layer thickness
Change in lipid layer thickness measured with the LipiViewII Ocular Surface Interferometer at predose and at defined time points after instillation of eyedrops
Tear Break Up Time (TBUT)
Tear Break Up Time measured at screening visit and on study day
Visual Analogue Scale (VAS)
Visual Analogue Scale about dry eye symptoms at screening visit and on study day
Schirmer I test
Schirmer I test measured at screening visit and on study
Ocular Surface Disease Index (OSDI) score
Ocular Surface Disease Index (OSDI) score assessed with questionnaire at screening visit
Corneal fluorescein staining
Corneal fluorescein staining at screening visit and on study day
Visual acuity
Visual acuity assessed at screening visit and on study day
Intraocular pressure (IOP)
Intraocular pressure measured at screening visit
Full Information
NCT ID
NCT03161080
First Posted
March 28, 2017
Last Updated
August 21, 2019
Sponsor
Medical University of Vienna
1. Study Identification
Unique Protocol Identification Number
NCT03161080
Brief Title
Effect of Single Instillation of Three Different Topical Lubricants on Tear Film Thickness in Patients With Dry Eye Syndrome
Official Title
Effect of Single Instillation of Three Different Topical Lubricants on Tear Film Thickness in Patients With Dry Eye Syndrome
Study Type
Interventional
2. Study Status
Record Verification Date
August 2019
Overall Recruitment Status
Completed
Study Start Date
February 9, 2017 (Actual)
Primary Completion Date
May 12, 2017 (Actual)
Study Completion Date
May 12, 2017 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Medical University of Vienna
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
Brief Summary
The prevalence and incidence of dry eye syndrome (DES) is constantly increasing. Several therapeutic strategies have been proposed, but still no ideal regimen has been found. Recently, a new method for the non- invasive measurement of tear film thickness (TFT) based on optical coherence tomography (OCT) has been developed. It has been shown in previous studies that TFT correlates well with objective signs as well as with subjective symptoms of DES.
In the present study the effects of three different topical lubricants (Neovis total multi®, Vismed multi® and Hydrabak® eye drops) on tear film thickness in patients with moderate to severe DES will be investigated using this device.
Tear film thickness will be measured at baseline and at defined time points after single instillation. The course of tear film thickness during this study day will provide information about the corneal residency time of the three different eye drops. Patients with moderate to severe DES will be randomized to receive either Neovis total multi®, Vismed multi® or Hydrabak® eye drops. Assessment of lipid layer thickness of the tear film will be performed before and at pre-specified time points after instillation as secondary outcome.
Other clinical measures for DES such as determination of tear film break up time (TFBUT), corneal fluorescein staining, Schirmer I test and subjective assessments will also be performed.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Dry Eye Syndromes
7. Study Design
Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Investigator
Allocation
Randomized
Enrollment
60 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Dry Eye Neovis
Arm Type
Experimental
Arm Description
20 Patients with dry eye syndrome receiving Neovis Total Multi Eyedrops
Arm Title
Dry Eye Vismed
Arm Type
Experimental
Arm Description
20 Patients with dry eye syndrome receiving Vismed Multi Eyedrops
Arm Title
Dry Eye Hydrabak
Arm Type
Experimental
Arm Description
20 Patients with dry eye syndrome receiving Hydrabak Eyedrops
Intervention Type
Device
Intervention Name(s)
Neovis Total Multi® Eye Drops
Intervention Description
Eye Drops containing Sodium hyaluronate (0.18%), lipoic acid, hydroxypropyl methylcellulose
Intervention Type
Device
Intervention Name(s)
Vismed Multi® Eye Drops
Intervention Description
Eye Drops containing Sodium hyaluronate (0.18%), potassium chloride, disodium phosphate
Intervention Type
Device
Intervention Name(s)
Hydrabak® Eye Drops
Intervention Description
Eye Drops containing sodium chloride (0,9%), sodium dihydrogen phosphate dehydrate
Primary Outcome Measure Information:
Title
Change in tear film thickness
Description
Change in tear film thickness measured with optical coherence tomography (OCT) at predose and at defined time points after instillation of eyedrops
Time Frame
1 day
Secondary Outcome Measure Information:
Title
Change in lipid layer thickness
Description
Change in lipid layer thickness measured with the LipiViewII Ocular Surface Interferometer at predose and at defined time points after instillation of eyedrops
Time Frame
1 day
Title
Tear Break Up Time (TBUT)
Description
Tear Break Up Time measured at screening visit and on study day
Time Frame
2 weeks
Title
Visual Analogue Scale (VAS)
Description
Visual Analogue Scale about dry eye symptoms at screening visit and on study day
Time Frame
2 weeks
Title
Schirmer I test
Description
Schirmer I test measured at screening visit and on study
Time Frame
2 weeks
Title
Ocular Surface Disease Index (OSDI) score
Description
Ocular Surface Disease Index (OSDI) score assessed with questionnaire at screening visit
Time Frame
1 day
Title
Corneal fluorescein staining
Description
Corneal fluorescein staining at screening visit and on study day
Time Frame
2 weeks
Title
Visual acuity
Description
Visual acuity assessed at screening visit and on study day
Time Frame
2 weeks
Title
Intraocular pressure (IOP)
Description
Intraocular pressure measured at screening visit
Time Frame
1 day
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria
Patients will be eligible for inclusion if all these criteria are respected:
Age of at least 18 years
Provides written informed consent prior to study-related procedures at the screening visit
Is able to understand and willing to comply with the procedures and the actions asked of him/her
History of dry eye syndrome for at least 3 months
Reports at least 2 of the following symptoms related to dry eye syndrome: foreign body sensation, pain, itching, stinging, epiphora, photophobia or blurred vision
Tear Break Up Time (BUT) ≤ 10 seconds or Schirmer I test ≤ 10 mm
OSDI score ≥ 23 points
Normal ophthalmic findings except dry eye syndrome
Exclusion Criteria
Patients will be excluded under the following circumstances:
Participation in a clinical trial in the 3 weeks preceding the study
Symptoms of a clinically relevant illness in the 3 weeks before the first study day
Presence or history of a severe medical condition as judged by the clinical investigator
Intake of parasympathomimetic or anti-psychotic drugs
Wearing of contact lenses
Glaucoma in the medical history
Treatment with corticosteroids in the 4 weeks preceding the study
Topical treatment with any ophthalmic drug except topical lubricants in the 4 weeks preceding the study
Ocular infection or clinically significant inflammation not related to dry eye syndrome
Ocular surgery in the 3 months preceding the study
Sjögren's syndrome
Stevens-Johnson syndrome
History of allergic conjunctivitis
Pregnancy, planned pregnancy or lactating
Known hypersensitivity to any component of the study medication
Facility Information:
Facility Name
Department of Clinical Pharmacology, Medical University of Vienna
City
Vienna
ZIP/Postal Code
1090
Country
Austria
12. IPD Sharing Statement
Citations:
PubMed Identifier
30325687
Citation
Szegedi S, Scheschy U, Schmidl D, Aranha Dos Santos V, Stegmann H, Adzhemian N, Fondi K, Bata AM, Werkmeister RM, Couderc C, Schmetterer L, Garhofer G. Effect of Single Instillation of Two Hyaluronic Acid-Based Topical Lubricants on Tear Film Thickness in Patients with Dry Eye Syndrome. J Ocul Pharmacol Ther. 2018 Nov;34(9):605-611. doi: 10.1089/jop.2018.0069. Epub 2018 Oct 16.
Results Reference
derived
Learn more about this trial
Effect of Single Instillation of Three Different Topical Lubricants on Tear Film Thickness in Patients With Dry Eye Syndrome
We'll reach out to this number within 24 hrs