1. A Randomised Cross Over Comparison of Trehalose/Hyaluronate Eye Drops and Standard Treatment: Patient Satisfaction in the Treatment of Dry Eye Syndrome
Juan Carlos Pinto-Bonilla, MD PhD 
Alberto Del Olmo-Jimeno, OD
Clínica Baviera
26 Avda. Sancho el Fuerte
Pamplona (Navarra)
Spain
Background
Dry Eye
The incidence of dry eye is increasing and despite better understanding of its pathophysiology more effective treatments are still required.
Thealoz Duo®
is a novel preparation that combines trehalose, an anhydrobiotic disaccharide widespread in single-celled organisms, plants and lower animals, with hyaluronic acid, a polymeric substance that is widespread in higher animals and is associated with water-retentive and lubricative functions.
Study Objective
To evaluate patient satisfaction with Thealoz Duo® and Systane® eye drops in the treatment of moderate to severe dry eye syndrome.

2. Methods 17 Patients were recruited, randomised, treated and evaluated
Single centre randomised, open label, cross-over trial.
Patients
20 patients were intended to be included with a target of 15 evaluable patients.
Male or female.
Moderate to severe dry eye syndrome (OSDI >25).
Patient having used tear substitutes in last 3 months should have at least 7 to 5 days wash out period.
Treatment
Patients were randomised to THEALOZ DUO® or SYSTANE®.
Primary Efficacy Variable
Patient satisfaction evaluated by a Visual Analogue Scale evaluated on days 0, 7, 12 and 19.
Secondary Efficacy Variables
OSDI
Patient diary; Global score of dry eye symptoms, on daily life, on daily activities, on emotions, on work, and global symptoms ocular score assessed by the patient.
Ocular staining (fluorescein test and the lissamine green staining)
Ocular clinical signs
Schirmer test, TBUT
Global efficacy as assessed by patient and investigator.
Treatment
THEALOZ DUO®, one drop 5 times daily for both eyes for 7 days
versus
SYSTANE®, one drop 5 times daily for both eyes for 7 days
17 Patients were recruited, randomised, treated and evaluated

3. Results – Primary Efficacy Variable
VAS satisfaction improved in both Thealoz Duo® and Systane® treated patients.
Thealoz Duo® resulted in greater improvement in patient satisfaction than did Systane® (p=0.043).

4. Results – Secondary efficacy variables
Two secondary efficacy parameters from patient’s diary showed statistically significant advantages for Thealoz Duo® over Systane®
Change of Dry eye symptoms; 16 questions evaluating the intensity of symptoms due to dryness
Change of Eye dryness impact on work.
There were no statistically significant advantages for Systane® over Thealoz Duo® for any parameter.

5. Conclusion
Thealoz Duo® is an effective treatment for dry eye syndrome. It is at least as effective as Systane® on all parameters examined.
There are statistically significant advantages for Thealoz- Duo® versus Systane for
The improvement of patient satisfaction concerning their eyes after treatment
The change between baseline and 7 days treatment for dry eye symptoms.
Change between baseline and 3 days and baseline and 7 days for dry eye symptoms impact on work.
There were no adverse events.