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The goal of this prospective, open, monocentric study is to evaluate the clinical efficacy of a new preservative-free combination of trehalose, sodium hyaluronate and NAAGA in 30 patients with chronic dry eye disease and associated ocular surface inflammation.
The main question it aims to answer is:
- To assess the improvement of conjunctival hyperemia as well as subjective symptoms in patients with moderate to severe dry eye.
Participants will be asked to use T2769 on a daily basis.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group receiving T2769 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| T2769 | Device | Preservative-free combination of trehalose, sodium hyaluronate and N-Acetyl Aspartyl Glutamic Acid |
|
| Measure | Description | Time Frame |
|---|---|---|
| Patient satisfaction with Visual Analog Scale (0-10) at week 12 - Descriptive analysis | Scores will be determined using a 100 mm VAS on which 0 means "I do not agree" and 100 means "I totally agree". The following questions will be assessed using VAS: "I feel satisfied using this treatment" "With these eye drops, I have a feeling of freshness" "With these eye drops, I have a feeling of relief" "This product contributed to reduce my pain due to eye dryness" "This product is comfortable" | at week 12 |
| Conjunctival hyperaemia assesment with Efron scale at week 12 | Conjunctival hyperemia grading with Photographs (Efron) scale at week 12
| week 12 |
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Inclusion Criteria:
Exclusion Criteria:
Ophthalmic exclusion criteria
Best far corrected visual acuity < 1/10
Severe Dry Eye associated with:
History of any of the following within last 3 months:
Systemic treatment of dry eye
Systemic treatment of MGD
Isotretinoïde,
Cyclosporine,
Tacrolimus, Siromilus, Pimecrolimus
Punctual plugs
History of any of the following within previous six months:
ocular trauma
ocular infection, Ocular allergy
History of any of the following within last 12 months:
inflammatory corneal ulcer
Herpetic eye infection
or uveitis
Ocular surgery
Systemic / non ophthalmic exclusion criteria:
• Known hypersensitivity to any of the components of the medical device under investigation or other study medication
Specific exclusion criteria for women:
Exclusion criteria related to general conditions
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A total of 30 patients with moderate to severe dry eye disease and associated inflammation.
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Universitätsklinik für Klinische Pharmakologie, Allgemeines Krankenhaus Wien | Vienna | Austria |
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| ID | Term |
|---|---|
| D015352 | Dry Eye Syndromes |
| ID | Term |
|---|---|
| D007766 | Lacrimal Apparatus Diseases |
| D005128 | Eye Diseases |
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Schirmer test strips stored for proteomics and lipidomics analysis