Page 7 - THEALOZ DUO LEAFLET CONGRES 2021_Slide

FOR PATIENTS WITH DRY EYES

TREHALOSE 3% | HYALURONIC ACID 0.15% | CARBOMER 0.25% MEDICAL DEVICE

Combination of trehalose, sodium hyaluronate and
carbomer for maximum comfort and bioprotection

• LONGER RESIDENCE TIME

The combination of trehalose 3% + hyaluronic acid 0.15% coupled with
carbomer 0.25%, offers a significantly longer increase in tear film
thickness indicating for a longer residence time 14
TH-HA-Carbomer Randomized, single masked, observer blinded parallel group
TFT (% change from baseline) 35 60 patients with history of DED for at least 3 months, BUT≤10s or
PG-PRG
HA
30
*
design.
*
25
Schirmer I test between 2 mm and 5 mm and OSDI≥22.
20
3 arms, patients received a single dose of either: Unpreserved.
15
Trehalose 3% + HA 0.15% + Carbomer 0.25% (Thealoz ® Duo Gel),
Hyaluronic Acid 0.2%, Polyethylene glycol 0.4% + propylene
10
glycol 0.3%.
5
0
30 60 120 240 360 Measurement of TFT.
Time (min)
*Significant vs baseline
• FEWER INSTILLATIONS
Lower instillation frequency when using Thealoz Duo Gel compared to artificial
®
tears 15
Drops PRN + Gel
Gel PRN* before going to bed
p-value
6 Baseline Study day Baseline Study day
p=0.02 Break Up Time 3.5 ± 1.7 4.2 ± 1.7 3.4 ± 1.4 4.3 ± 1.9 <0.001
5
* Corneal Fluorescein 3.5 ± 2.3 2.7 ± 2.1 3.1 ± 1.7 2.2 ± 1.4 <0.001
Staining
Average drops / day 3 2 N=40 patients with moderate to severe dry eye disease. Randomized,
4
Conjunctival Lissamine
<0.001
3.5 ± 2.6
4.4 ± 2.5
2.8 ± 2.3
4.5 ± 2.8
Green Staining
*PRN = pro re nata = according to needs
eye drops for use during the day combined with Thealoz ® Duo gel before
1 observer-masked, cross-over study. Patients received either Thealoz ® Duo
going to bed or Thealoz ® Duo Gel only to use as needed (PRN) for one week.
Then, after another one week washout period, patients crossed over to the
0 other treatment group.
Eye Drops PRN + Gel Gel PRN
14. Thealoz Duo gel OCT study : Schmidl D. et al. Effect of gel-based artificial tears on tear film thickness in patients with dry eye diseas. Investigate
®
Ophthalmology & Visual Science September 2016, Vol .57, 2881. 7
15. Cross over study : Schmidl D. et al. Difference in the frequency of use of lachrymal substitutes in patients with moderate to severe dry eye disease . Poster
on 8th International Conference on the Tear Film & Ocular Surface 2016.