Effect of Lipid Based Eye Drops on Tear Film Lipid Layer Thickness (NCT03399292) | Clinical Trial Compass
CompletedNot Applicable
Effect of Lipid Based Eye Drops on Tear Film Lipid Layer Thickness
Austria12 participantsStarted 2017-04-12
Plain-language 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.
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
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
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
* 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
Exclusion Criteria:
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
* Treatment with topical or systemic steroids,…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Tear film lipid layer thickness as measured with Lipiview II