Dry Eye Disease (DED)
Conditions
Brief summary
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.
Interventions
DEVICET2769
Preservative-free combination of trehalose, sodium hyaluronate and N-Acetyl Aspartyl Glutamic Acid
Sponsors
Laboratoires Thea
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Age ≥ 18 years * Normal ophthalmic findings except dry eye disease * Chronic dry eye defined as longer than six months since diagnosis * OSDI ≥ 22 * Conjunctival Hyperemia≥ Grade 3 (Efron Scale) * Current use of topical lubricants since at least 3 months
Exclusion criteria
Ophthalmic
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Patient satisfaction with Visual Analog Scale (0-10) at week 12 - Descriptive analysis | at week 12 | 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 |
| Conjunctival hyperaemia assesment with Efron scale at week 12 | week 12 | Conjunctival hyperemia grading with Photographs (Efron) scale at week 12 * Descriptive analysis * Cross table baseline vs week 12; McNemar Bowker (0) = None 1. = Trace 2. = Mild 3. = Moderate 4. = Severe |
Countries
Austria
Outcome results
None listed