Dry Eye SyndromeNCT01753687
Correlation of Different Signs for Assessment of Dry Eye Syndrome
A study testing Ocular scattering of the tear film, Optical Coherence Tomography (OCT) and Measurement of tear film osmolarity in people with Dry Eye Syndrome, run by Medical University of Vienna at 1 site in Austria.
Trial summary
Dry eye syndrome (DES) is a highly prevalent ocular condition inducing an inflammatory response of the ocular surface. Common symptoms include ocular discomfort, visual impairment and instability of the tear film with potential damage to the ocular surface. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Dry Eye Syndrome
- What is being tested?
- Ocular scattering of the tear film, Optical Coherence Tomography (OCT) and Measurement of tear film osmolarity
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteAustria
- Study dates
- Sep 2011to Sep 2013
- 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
- Men and women aged over 18 years
- History of dry eye syndrome for at least 3 months
- At least 2 symptoms of dry eye syndrome (foreign body sensation, burning, photophobia, blurred vision, pain, itching) and/or tear break up time < 10 seconds
- Normal ophthalmic findings except dry eye syndrome
Who cannot join
- 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 that will interfere with the study aim as judged by the clinical investigator
- Wearing of contact lenses
- Intake of dietary supplements in the 3 months preceding the study
- Glaucoma
Show all 13Show fewer
- Treatment with corticosteroids in the 4 weeks preceding the study
- Topical treatment with any ophthalmic drug in the 4 weeks preceding the study except topical lubricants
- Ocular infection or clinically significant inflammation
- Ocular surgery in the 3 months preceding the study
- Sjögren's syndrome
- Stevens-Johnson syndrome
- Pregnancy, planned pregnancy or lactating
Trial locations and contacts
1 site in 1 country.
Austria1 site
Department of Clinical Pharmacology, Medical University of Vienna
Vienna, State of Vienna, 1090
About this study
Dry eye syndrome (DES) is a highly prevalent ocular condition inducing an inflammatory response of the ocular surface. Common symptoms include ocular discomfort, visual impairment and instability of the tear film with potential damage to the ocular surface.
The rationale of the present study is to compare signs as assessed with new methods such as measurement of tear film thickness, tear film osmolarity and scattering of the tear film with well established methods for assessment of the severity of DES (Break up time, staining of the cornea with fluorescein). Additionally, impression cytology and determination of tear cytokines/chemokines will be performed to obtain information about inflammatory processes on the ocular surface.
- Conditions
- Dry Eye Syndrome
- Being tested
- Ocular scattering of the tear film, Optical Coherence Tomography (OCT), Measurement of tear film osmolarity
- Keywords
- break up time, tear film thickness, tear film osmolarity, objective scattering index, impression cytology, tear cytokines/chemokines, visual acuity, fluorescein staining
- 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.
Ocular scattering of the tear filmOther
Also called OQAS, Visometrics, Spain
Optical Coherence Tomography (OCT)Other
Tear film thickness as measured with OCT
Measurement of tear film osmolarityOther
Also called TearLab®, OcuSens Inc, San Diego, USA
| Study group | Role | What they receive |
|---|---|---|
| 50 patients with dry eye syndrome | Other | Not described Receives: Other: Ocular scattering of the tear film; Other: Optical Coherence Tomography (OCT); Other: Measurement of tear film osmolarity |
What is being measured
The primary outcome is the main question the study is designed to answer.
Break up time
break up time of the tear film measured in seconds
Measured: once on the study day
Tear film thickness as measured with optical coherence tomography (OCT)
tear film thickness measured in micrometers
Measured: once on the study day
Secondary outcomes (7)
Visual Acuity
Total number of letters read using ETDRS Charts
Measured: once on the study day
Tear film osmolarity
Tear film osmolarity measured in mosmol/l
Measured: once on the study day
OSI (Objective Scattering Index)
The objective scattering index will be measured using the OQAS system (Visiometrics, Spain)
Measured: once on the study day
Staining of the cornea with fluorescein
The cornea will be divided into 5 regions (central, inferior, nasal, temporal, inferior) and each region will be graded from 0-4 in 0.5 steps as described in the Collaborative Longitudinal Evaluation of Keratoconus (CLEK) study.
Measured: once on the study day
Impression cytology
After topical anesthesia of the eye, filter material is placed on the conjunctiva to obtain cytological samples, which will be prepared and evaluated.
Measured: once on the study day
Tear cytokines/chemokines
Samples of 40 µl tears will be taken with a glass capillary and stored in vials. The concentrations of several cytokines and chemokines will be evaluated.
Measured: once on the study day
Subjective symptoms of dry eye syndrome
a questionaire will be used
Measured: once on the study day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Dec 2012 (estimated)
- Study startSep 2011
- Primary completionJul 2013
- Study completionSep 2013
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 SyndromeStudies 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
- Not applicable
- Intervention model
- Single group
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 50 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
- NCT01753687
- Sponsor's protocol ID
- OPHT-300511
- Status last verified
- Nov 2013
- First submitted
- 7 Dec 2012
- Last updated
- 27 Nov 2013
- Results posted
- No
- Data monitoring committee
- No
Publications
Schmidl D, Witkowska KJ, Kaya S, Baar C, Faatz H, Nepp J, Unterhuber A, Werkmeister RM, Garhofer G, Schmetterer L. The association between subjective and objective parameters for the assessment of dry-eye syndrome. Invest Ophthalmol Vis Sci. 2015 Feb 3;56(3):1467-72. doi: 10.1167/iovs.14-15814.
PubMed 25650419
Study at a glance
From the registry record, last updated by the sponsor on 27 Nov 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Correlation of Different Signs for Assessment of Dry Eye Syndrome
- ClinicalTrials.gov ID
- NCT01753687
- Acronym / sponsor ID
- OPHT-300511
- Conditions
- Dry Eye Syndrome
- Keywords
- break up time, tear film thickness, tear film osmolarity, objective scattering index, impression cytology, tear cytokines/chemokines, visual acuity, fluorescein staining
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Medical University of ViennaUniversity, hospital or other
- Study start
- Sep 2011
- Primary completion
- Jul 2013 (actual)
- Study completion
- Sep 2013 (actual)
- First posted
- 20 Dec 2012 (estimated)
- 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.
Dry eye syndrome (DES) is a highly prevalent ocular condition inducing an inflammatory response of the ocular surface. Common symptoms include ocular discomfort, visual impairment and instability of the tear film with potential damage to the ocular surface.
The rationale of the present study is to compare signs as assessed with new methods such as measurement of tear film thickness, tear film osmolarity and scattering of the tear film with well established methods for assessment of the severity of DES (Break up time, staining of the cornea with fluorescein). Additionally, impression cytology and determination of tear cytokines/chemokines will be performed to obtain information about inflammatory processes on the ocular surface.
Study design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 50 patients with dry eye syndrome | Other | Other: Ocular scattering of the tear film, Other: Optical Coherence Tomography (OCT), Other: Measurement of tear film osmolarity |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Men and women aged over 18 years
- History of dry eye syndrome for at least 3 months
- At least 2 symptoms of dry eye syndrome (foreign body sensation, burning, photophobia, blurred vision, pain, itching) and/or tear break up time < 10 seconds
- Normal ophthalmic findings except dry eye syndrome
Key exclusion criteria (13 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 that will interfere with the study aim as judged by the clinical investigator
- Wearing of contact lenses
- Intake of dietary supplements in the 3 months preceding the study
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 |
|---|---|---|
| Ocular scattering of the tear filmAlso: OQAS, Visometrics, Spain | Other | 50 patients with dry eye syndrome |
| Optical Coherence Tomography (OCT)Tear film thickness as measured with OCT | Other | 50 patients with dry eye syndrome |
| Measurement of tear film osmolarityAlso: TearLab®, OcuSens Inc, San Diego, USA | Other | 50 patients with dry eye syndrome |
Primary outcome
Break up time
Time frame: once on the study day
break up time of the tear film measured in seconds
Tear film thickness as measured with optical coherence tomography (OCT)
Time frame: once on the study day
tear film thickness measured in micrometers
7 secondary outcomes
Visual Acuity
Time frame: once on the study day
Tear film osmolarity
Time frame: once on the study day
OSI (Objective Scattering Index)
Time frame: once on the study day
Staining of the cornea with fluorescein
Time frame: once on the study day
Impression cytology
Time frame: once on the study day
Tear cytokines/chemokines
Time frame: once on the study day
Subjective symptoms of dry eye syndrome
Time frame: once on the study 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 27 Nov 2013.
- Derived from this study: PubMed 25650419Schmidl D, Witkowska KJ, Kaya S, Baar C, Faatz H, Nepp J, Unterhuber A, Werkmeister RM, Garhofer G, Schmetterer L. The association between subjective and objective parameters for the assessment of dry-eye syndrome. Invest Ophthalmol Vis Sci. 2015 Feb 3;56(3):1467-72. doi: 10.1167/iovs.14-15814.
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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 Ocular scattering of the tear film, Optical Coherence Tomography (OCT) and Measurement of tear film osmolarity in people with Dry Eye Syndrome, 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 4 inclusion and 13 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 27 Nov 2013. 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?
Break up time (time frame: once on the study day). The study lists 2 primary outcomes in all. 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 NCT01753687, 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 27 Nov 2013.