Dry Eye SyndromesNCT03161080
Effect of Single Instillation of Three Different Topical Lubricants on Tear Film Thickness in Patients With Dry Eye Syndrome
A study testing Neovis Total Multi® Eye Drops, Vismed Multi® Eye Drops and Hydrabak® Eye Drops in people with Dry Eye Syndromes, run by Medical University of Vienna at 1 site in Austria.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Dry Eye Syndromes
- What is being tested?
- Neovis Total Multi® Eye Drops, Vismed Multi® Eye Drops and Hydrabak® Eye Drops
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteAustria
- Study dates
- 9 Feb 2017to 12 May 2017
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Show all 9Show fewer
- Tear Break Up Time (BUT) ≤ 10 seconds or Schirmer I test ≤ 10 mm
- OSDI score ≥ 23 points
- Normal ophthalmic findings except dry eye syndrome
Who cannot join
- 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
Show all 16Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
Austria1 site
Department of Clinical Pharmacology, Medical University of Vienna
Vienna, 1090
About this study
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.
Read more
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.
- Conditions
- Dry Eye Syndromes
- Being tested
- Neovis Total Multi® Eye Drops, Vismed Multi® Eye Drops, Hydrabak® Eye Drops
- Medical subject headings
- Dry Eye Syndromes
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Neovis Total Multi® Eye DropsDevice
Eye Drops containing Sodium hyaluronate (0.18%), lipoic acid, hydroxypropyl methylcellulose
Vismed Multi® Eye DropsDevice
Eye Drops containing Sodium hyaluronate (0.18%), potassium chloride, disodium phosphate
Hydrabak® Eye DropsDevice
Eye Drops containing sodium chloride (0,9%), sodium dihydrogen phosphate dehydrate
| Study group | Role | What they receive |
|---|---|---|
| Dry Eye Neovis | Experimental | 20 Patients with dry eye syndrome receiving Neovis Total Multi Eyedrops Receives: Device: Neovis Total Multi® Eye Drops |
| Dry Eye Vismed | Experimental | 20 Patients with dry eye syndrome receiving Vismed Multi Eyedrops Receives: Device: Vismed Multi® Eye Drops |
| Dry Eye Hydrabak | Experimental | 20 Patients with dry eye syndrome receiving Hydrabak Eyedrops Receives: Device: Hydrabak® Eye Drops |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 1 day
Secondary outcomes (8)
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
Measured: 1 day
Tear Break Up Time (TBUT)
Tear Break Up Time measured at screening visit and on study day
Measured: 2 weeks
Visual Analogue Scale (VAS)
Visual Analogue Scale about dry eye symptoms at screening visit and on study day
Measured: 2 weeks
Schirmer I test
Schirmer I test measured at screening visit and on study
Measured: 2 weeks
Ocular Surface Disease Index (OSDI) score
Ocular Surface Disease Index (OSDI) score assessed with questionnaire at screening visit
Measured: 1 day
Corneal fluorescein staining
Corneal fluorescein staining at screening visit and on study day
Measured: 2 weeks
Visual acuity
Visual acuity assessed at screening visit and on study day
Measured: 2 weeks
Intraocular pressure (IOP)
Intraocular pressure measured at screening visit
Measured: 1 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 May 2017
- Study start9 Feb 2017
- Primary completion12 May 2017
- Study completion12 May 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Dry Eye SyndromesStudies of the same condition, open and under way.
- More trials run by Medical University of ViennaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Medical University of Vienna
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Gerhard Garhofer, Medical University of Vienna
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03161080
- Sponsor's protocol ID
- OPHT-250716
- Status last verified
- Aug 2019
- First submitted
- 28 Mar 2017
- Last updated
- 22 Aug 2019
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 30325687
Study at a glance
From the registry record, last updated by the sponsor on 22 Aug 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Single Instillation of Three Different Topical Lubricants on Tear Film Thickness in Patients With Dry Eye Syndrome
- ClinicalTrials.gov ID
- NCT03161080
- Acronym / sponsor ID
- OPHT-250716
- Conditions
- Dry Eye Syndromes
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Medical University of ViennaUniversity, hospital or other
- Study start
- 9 Feb 2017 (actual)
- Primary completion
- 12 May 2017 (actual)
- Study completion
- 12 May 2017 (actual)
- First posted
- 19 May 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Dry Eye Neovis | Experimental | Device: Neovis Total Multi® Eye Drops20 Patients with dry eye syndrome receiving Neovis Total Multi Eyedrops |
| Dry Eye Vismed | Experimental | Device: Vismed Multi® Eye Drops20 Patients with dry eye syndrome receiving Vismed Multi Eyedrops |
| Dry Eye Hydrabak | Experimental | Device: Hydrabak® Eye Drops20 Patients with dry eye syndrome receiving Hydrabak Eyedrops |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- 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
Key exclusion criteria (16 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Neovis Total Multi® Eye DropsEye Drops containing Sodium hyaluronate (0.18%), lipoic acid, hydroxypropyl methylcellulose | Device | Dry Eye Neovis |
| Vismed Multi® Eye DropsEye Drops containing Sodium hyaluronate (0.18%), potassium chloride, disodium phosphate | Device | Dry Eye Vismed |
| Hydrabak® Eye DropsEye Drops containing sodium chloride (0,9%), sodium dihydrogen phosphate dehydrate | Device | Dry Eye Hydrabak |
Primary outcome
Change in tear film thickness
Time frame: 1 day
Change in tear film thickness measured with optical coherence tomography (OCT) at predose and at defined time points after instillation of eyedrops
8 secondary outcomes
Change in lipid layer thickness
Time frame: 1 day
Tear Break Up Time (TBUT)
Time frame: 2 weeks
Visual Analogue Scale (VAS)
Time frame: 2 weeks
Schirmer I test
Time frame: 2 weeks
Ocular Surface Disease Index (OSDI) score
Time frame: 1 day
Corneal fluorescein staining
Time frame: 2 weeks
Visual acuity
Time frame: 2 weeks
Intraocular pressure (IOP)
Time frame: 1 day
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Aug 2019.
- Derived from this study: PubMed 30325687Szegedi 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Neovis Total Multi® Eye Drops, Vismed Multi® Eye Drops and Hydrabak® Eye Drops in people with Dry Eye Syndromes, run by Medical University of Vienna at 1 site in Austria.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 22 Aug 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Austria. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in tear film thickness (time frame: 1 day). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03161080, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Aug 2019.