Efficacy and Safety of BUFY02 Versus TRB02 in the Treatment of Dry Eye Disease

Study Overview
=================
Brief Summary
-----------------
The goal of this interventional investigation is to compare BUFY02 with TRB02 in the treatment of patients with dry eye disease. The main questions it aims to answer are: Is BUFY02 non-inferior to TRB02 in terms of signs of DED? Is BUFY02 non-inferior to TRB02 in terms of symptoms of DED? Participants will be asked to: Visit the trial site at 4 different timepoints Use the allocated study treatment everyday until the end of the study (during 3 months) Be examined by the investigator Complete several questionnaires Return unused study treatment. Researchers will compare BUFY02 to TRB02 to see if both study treatments provide similar effects on signs and symptoms of the disease, together with comparable safety.

Official Title
-----------------
Efficacy and Safety of BUFY02 Versus TRB02 in the Treatment of Dry Eye Disease: a Non-inferiority Investigation

Conditions
-----------------
Dry Eye Disease

Intervention / Treatment
-----------------
* Device: BUFY02 eye drops in single-dose containers
* Device: TRB02 eye drops in single-dose containers


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria include: At least a 3-month documented history of bilateral dry eye syndrome needing artificial tears; At least one eye with Oxford score ≥ 4 and ≤ 9; At least one objective sign of tear deficiency (in at least one eligible eye); Having a health insurance. Exclusion Criteria include: Wear of contact lenses starting within the last 2 months; Best-corrected visual acuity (BCVA) < 1/10; Severe DED with one of the listed conditions: Severe blepharitis; Seasonal allergy; Any issues of the ocular surface not related to DED; History of ocular trauma, infection or inflammation not related to DED; History of ocular surgery, including laser surgery; Unstable glaucoma; Use of artificial tears with preservative within the last 2 weeks; Systemic (enteral or parenteral) or local (topical) use of one of the listed medications: Known hypersensitivity to any constituent of the study treatments; Pregnancy or breastfeeding; Participation in another clinical study within the last 90 days; Legally restricted autonomy, freedom of decision and action.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: BUFY02<br>0.3% Sodium Hyaluronate (trometamol buffer) in single-dose containers of 0.45 mL | Device: BUFY02 eye drops in single-dose containers<br>* 1 to 2 drops in each eye, as often as needed<br>|
| Active Comparator: TRB02<br>0.3% Sodium Hyaluronate (phosphate buffer) in single-dose containers of 0.45 mL | Device: TRB02 eye drops in single-dose containers<br>* 1 to 2 drops in each eye, as often as needed<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Signs | Change from baseline in Oxford score (0-15, a higher score meaning a worse outcome) | Day 28 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Symptoms | Change from baseline in Ocular Surface Disease Index | Day 28 |