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| Name | Class |
|---|---|
| Lamellar Biomedical Ltd | INDUSTRY |
| University of Glasgow | OTHER |
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Single-blind, randomised, single centre, 2-way crossover study to collect post-market clinical follow-up data on the CE-marked Lamelleye dry eye drops medical device.
The study is a 2-way crossover design comprising 2 treatments: the CE-marked Lamelleye dry eye drops, and a CE-marked comparator product. All Participants will be allocated to a treatment group in a random order.
This study design allows observations to be made between the treatments at both an intra- and inter-patient level regarding relationships between the patients' disease specific quality of life, symptoms and adverse events.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Treatment A, followed by Treatment B | Other | Treatment group that will receive Treatment A for 14 days, followed by Treatment B for 14 days. There will be a minimum 7 day washout between Treatments. Lamelleye Dry Eye Drops and Optive Plus will be administered to all subjects in this arm. Treatments will be self-administered at least 3 times a day. |
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| Treatment B, followed by Treatment A | Other | Treatment group that will receive Treatment B for 14 days, followed by Treatment A for 14 days. There will be a minimum 7 day washout between Treatments. Lamelleye Dry Eye Drops and Optive Plus will be administered to all subjects in this arm. Treatments will be self-administered at least 3 times a day. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Lamelleye Dry Eye Drops | Device | Liposomal multi-dose preservative-free sterile suspension which contains soy lecithin phospholipids, sphingomyelin and cholesterol, suspended in saline. |
| Measure | Description | Time Frame |
|---|---|---|
| Non-invasive tear break-up time (outcome used to power study) | Measure of time taken from blink to breakup of tear film | 14 days (analysed for each Treatment period) |
| Measure | Description | Time Frame |
|---|---|---|
| Ocular Surface Disease Index (OSDI) | 12-item questionnaire designed to assess the symptoms of ocular irritation consistent with dry eye disease and their impact on vision-related functioning | 14 days (analysed for each Treatment period) |
| Symptom Assessment in Dry Eye (SANDE) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Ian Pearce | Glasgow Caledonian University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Glasgow Caledonian University | Glasgow | Scotland | G4 0BA | United Kingdom |
No individual participant data will be made available
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| ID | Term |
|---|---|
| D015352 | Dry Eye Syndromes |
| ID | Term |
|---|---|
| D007766 | Lacrimal Apparatus Diseases |
| D005128 | Eye Diseases |
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| Optive Plus | Device | Multi-dose sterile solution which contains sodium carboxymethylcellulose, glycerine, Castor Oil, Polysorbate 80, levocarnitine, and erythritol, preserved with PURITEĀ® which breaks down into natural tear components in the eye |
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Two questions which each use a horizontal visual analogue technique to quantify patient symptomatology of dryness and/or irritation |
| 14 days (analysed for each Treatment period) |
| Evaporimetry | Measure of the rate of evaporation of the tear film from the surface of the eye. | 14 days (analysed for each Treatment period) |
| Interferometry | Tear film lipid layer interferometry is a test to study the structure and quality of the lipid layer in the tear film. | 14 days (analysed for each Treatment period) |
| Osmolarity | Tear osmolarity is a test to determine the solute concentration of the tear film. | 14 days (analysed for each Treatment period) |
| Corneal and Conjunctival Staining | Corneal and conjunctival damage due to dry eye can be measured by staining the surface of the eye with fluorescein and examining under a lamp with a cobalt blue filter | 14 days (analysed for each Treatment period) |