HYLO DUAL INTENSE® versus THEALOZ DUO GEL eye drops in the treatment of patients with dry eye symptoms

INTERVENTION: Screening comprises 60 patients with moderate to severe dry eye disease (30 patients per group). The groups formed are: Group 1: HYLO DUAL INTENSE®, 3 x 1 drop per day Group 2: THEALOZ DUO GEL, 3 x 1 drop per day The eye drops are applied into the conjunctival sac of the patient. Randomisation numbers are calculated using block randomisation for sequence generation. A randomisation list is created by an independent person. Due to the single‐blind set‐up, it is not evident to the investigator whether HYLO DUAL INTENSE® or THEALOZ DUO GEL is applied. Emergency envelopes (code breakers) are prepared for urgent unblinding. CONDITION: Dry eye disease ; Eye Diseases ; Other disorders of lacrimal gland PRIMARY OUTCOME: Non‐invasive Tear Break Up Time (NIBUT) measured using a Scheimpflug camera at day 1 and day 28±3 SECONDARY OUTCOME: ; 1. Examination of eyelid margins using a slit lamp at day 1, day 28±3 and day 56±4; 2. Examination of the conjunctiva (hyperaemia and after vital staining) using a slit lamp at day 1, day 28±3 and day 56±4; 3. Examination of the cornea after vital staining using a slit lamp at day 1, day 28±3 and day 56±4; 4. Thickness of lipid layer (LLT) measured with the Kowa DR‐1 a Dry Eye Monitor at day 1, day 28±3 and day 56±4; 5. Subjective discomfort feeling measured using the Ocular Surface Disease Index at day 1, day 28±3 and day 56±4; 6. Intraocular pressure (IOP) measured using a Huvitz non‐contact tonometer at day 1, day 28±3 and day 56±4; 7. Visual acuity measured in decimal numbers by line read with correction at day 1, day 28±3 and day 56±4; 8. Tolerability evaluated by questioning the patient at day 28±3 and day 56±4; 9. Efficacy assessed by questioning the investigator at day 56±4; 10. Tolerability assessed by questioning the investigator at day 56±4; 11. Frequency and number of investigational product‐related adverse, and serious adverse events by questioning at day 28±3 and day 56±4; 12. Non‐invasive tear break up time (NIBUT) measured using a Scheimpflug camera at day 1, 28±3 and 56±4; INCLUSION CRITERIA: 1. Male and female patients =18 years of age 2. Patients with binocular moderate to severe dry eyes since at least 3 month and defined as: 2.1. Non‐invasive tear‐film breakup time (NIBUT) =5 sec 2.2. Degree of staining of the eye surface is between =3 and =9 on the Oxford Grading Scale with 15 points 3. Subjective complaints in the sense of a moderate to severe dry eye since at least 3 months: OSDI© =23 4. Ability of the patient to provide informed consent 5. The patient is able and ready to meet the requirements of the protocol