Dry Eye SyndromesNCT03399292
Effect of Lipid Based Eye Drops on Tear Film Lipid Layer Thickness
An observational study of Dry Eye Syndromes, run by Medical University of Vienna at 1 site in Austria.
Trial summary
Dry eye disease (DED) is a common ocular disease, especially in the elderly population. Despite many treatment approaches, instillation of topical lubricants remains the mainstay of therapy. However, most of the topical lubricants available are not very well characterised and data about efficacy is sparse. 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?
- Cationorm MD sine eye drops
- How many people
- 12 participants
- Where
- 1 siteAustria
- Study dates
- 12 Apr 2017to 26 Nov 2024
- Phase
- Observational
- 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
Study population: 10 healthy male and female volunteers 10 male and female subjects with dry eye disease 10 male and female subjects with Meibomian gland dysfunction 10 male and female subjects with blepharospasm
Who may be able to join
- All groups
- Men and women aged over 18 years
- Normal findings in the medical history unless the investigator considers an abnormality to be clinically irrelevant
- Ametropy < 6 dpt
- No application of eye drops or ointments in the 24 hours preceding the screening visit as well as the study day Dry eye disease group
- History of dry eye disease ≥ 3 months
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- Schirmer I test ≤ 10 mm and ≥ 2 mm or BUT ≤ 10 sec
- Normal ophthalmic findings with the exception of DED Meibomian gland disease group
- Dry eye disease most likely caused by MGD, no other cause identifiable which is more likely (e.g. intake of concomitant medication that could induce DED, systemic diseases such as systemic arthritis or diabetes), as judged by the investigator
- History of dry eye disease ≥ 3 months
- Normal ophthalmic findings except dry eye disease
- BUT ≤ 10 seconds Blepharospasm group
- Clinical diagnosis of blepharospasm
- Normal ophthalmic findings with the exception of blepharospasm and dry eye
- Schirmer I test > 10 mm and BUT > 10 sec
Who cannot join
- All groups
- Clinically relevant illness in the 3 weeks before the screening or study day
- Ametropy ≥ 6 dpt
- Pregnancy or planned pregnancy
- Difference of more than 5 mm in Schirmer I test or difference of > 3 sec in BUT between the two eyes
- Known medical history of allergy, hypersensitivity or poor tolerance to any components of the medical device used in the study
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- Treatment with topical or systemic steroids, immune suppressants, NSAIDs: ongoing or in the last 4 weeks
- Treatment with medication known to have a detrimental effect on tear film (e.g. antidepressants, anxiolytics, neuroleptics, antihistaminic drugs, cholinergic drugs, antimuscarinic drugs, phenothiazine, beta blockers): treatment duration ≤ 4 weeks or changed dose since ≤ 4 weeks or during the study
- Alcohol abuse
- Contact lens wear Meibomian gland dysfunction group
- Sjögren's syndrome
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
Official title: Effect of Lipid Based Eye Drops on Tear Film Lipid Layer Thickness in Subjects With Dry Eye Disease, Meibomian Gland Dysfunction, Blepharospasm and Healthy Subjects - a Pilot Study
Dry eye disease (DED) is a common ocular disease, especially in the elderly population. Despite many treatment approaches, instillation of topical lubricants remains the mainstay of therapy. However, most of the topical lubricants available are not very well characterised and data about efficacy is sparse.
The aim of the present pilot study is to investigate the effect of topically administered lipid based eye drops on tear film lipid layer thickness in subjects with dry eye disease, Meibomian gland dysfunction, blepharospasm and healthy subjects.
Tear film lipid layer and tear film thickness will be assessed using the Lipiview II interferometer and OCT. Measurements will be performed before instillation of the eye drops and every 10 minutes after instillation for one hour. One eye will receive lipid based eye drops, the other eye will receive no eye drops and will be used as control. The study eye will be chosen randomly. In addition, Dynamic Meibomian gland imaging, Schirmer I test, corneal fluorescein staining and determination of tear break up time (BUT) will be performed
- Conditions
- Dry Eye Syndromes
- Being tested
- Cationorm MD sine eye drops
- Keywords
- Lipid based eye drops, Tearfilm lipid layer thickness
- 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.
Cationorm MD sine eye dropsDrug
studyparticipants receive lipidbased eye drops once only in the study eye
| Study group | Role | What they receive |
|---|---|---|
| Group 1 | 10 male and female healthy subjects receive Cationorm MD sine eye drops once Receives: Drug: Cationorm MD sine eye drops | |
| Group 2 | 10 male and female volunteers with dry eye disease receive Cationorm MD sine eye drops once Receives: Drug: Cationorm MD sine eye drops | |
| Group 3 | 10 male and female volunteers with Maibomian gland disease receive Cationorm MD sine eye drops once Receives: Drug: Cationorm MD sine eye drops | |
| Group 4 | 10 male and female volunteers with receive Cationorm MD sine eye drops once Receives: Drug: Cationorm MD sine eye drops |
What is being measured
The primary outcome is the main question the study is designed to answer.
Tear film lipid layer thickness as measured with Lipiview II
Measured: 12.04.2017-30.12.2018
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jan 2018
- Study start12 Apr 2017
- Primary completion26 Nov 2024
- Study completion26 Nov 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 12 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
- NCT03399292
- Sponsor's protocol ID
- OPHT-031116
- Status last verified
- Apr 2022
- First submitted
- 8 Jan 2018
- Last updated
- 23 May 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Lipid Based Eye Drops on Tear Film Lipid Layer Thickness in Subjects With Dry Eye Disease, Meibomian Gland Dysfunction, Blepharospasm and Healthy Subjects - a Pilot Study
- ClinicalTrials.gov ID
- NCT03399292
- Acronym / sponsor ID
- OPHT-031116
- Conditions
- Dry Eye Syndromes
- Keywords
- Lipid based eye drops, Tearfilm lipid layer thickness
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 12 participants (actual)
- Lead sponsor
- Medical University of ViennaUniversity, hospital or other
- Study start
- 12 Apr 2017 (actual)
- Primary completion
- 26 Nov 2024 (actual)
- Study completion
- 26 Nov 2024 (actual)
- First posted
- 16 Jan 2018 (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.
Dry eye disease (DED) is a common ocular disease, especially in the elderly population. Despite many treatment approaches, instillation of topical lubricants remains the mainstay of therapy. However, most of the topical lubricants available are not very well characterised and data about efficacy is sparse.
The aim of the present pilot study is to investigate the effect of topically administered lipid based eye drops on tear film lipid layer thickness in subjects with dry eye disease, Meibomian gland dysfunction, blepharospasm and healthy subjects.
Tear film lipid layer and tear film thickness will be assessed using the Lipiview II interferometer and OCT. Measurements will be performed before instillation of the eye drops and every 10 minutes after instillation for one hour. One eye will receive lipid based eye drops, the other eye will receive no eye drops and will be used as control. The study eye will be chosen randomly. In addition, Dynamic Meibomian gland imaging, Schirmer I test, corneal fluorescein staining and determination of tear break up time (BUT) will be performed
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Group 1 | – | Drug: Cationorm MD sine eye drops10 male and female healthy subjects receive Cationorm MD sine eye drops once |
| Group 2 | – | Drug: Cationorm MD sine eye drops10 male and female volunteers with dry eye disease receive Cationorm MD sine eye drops once |
| Group 3 | – | Drug: Cationorm MD sine eye drops10 male and female volunteers with Maibomian gland disease receive Cationorm MD sine eye drops once |
| Group 4 | – | Drug: Cationorm MD sine eye drops10 male and female volunteers with receive Cationorm MD sine eye drops once |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- 10 healthy male and female volunteers 10 male and female subjects with dry eye disease 10 male and female subjects with Meibomian gland dysfunction 10 male and female subjects with blepharospasm
Key inclusion criteria (15 listed)
- All groups
- Men and women aged over 18 years
- Normal findings in the medical history unless the investigator considers an abnormality to be clinically irrelevant
- Ametropy < 6 dpt
- No application of eye drops or ointments in the 24 hours preceding the screening visit as well as the study day Dry eye disease group
Key exclusion criteria (11 listed)
- All groups
- Clinically relevant illness in the 3 weeks before the screening or study day
- Ametropy ≥ 6 dpt
- Pregnancy or planned pregnancy
- Difference of more than 5 mm in Schirmer I test or difference of > 3 sec in BUT between the two eyes
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 |
|---|---|---|
| Cationorm MD sine eye dropsstudyparticipants receive lipidbased eye drops once only in the study eye | Drug | Group 1, Group 2, Group 3, Group 4 |
Primary outcome
Tear film lipid layer thickness as measured with Lipiview II
Time frame: 12.04.2017-30.12.2018
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 23 May 2025.
- Individual participant dataSharing planned: No
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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?
An observational study of 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 15 inclusion and 11 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 23 May 2025. 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?
Tear film lipid layer thickness as measured with Lipiview II (time frame: 12.04.2017-30.12.2018). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 23 May 2025.