Influence of Three Different Formulations of Lachrymal Substitutes on Tear Film Thickness and Other Signs and Symptoms in Patients With Moderate to Severe Dry Eye Syndrome

Recruitment & Eligibility

Inclusion Criteria

Men and women aged over 18 years
Signed and dated written informed consent
History of dry eye syndrome for at least 3 months
Tear Break Up Time (BUT) ≤ 10 seconds or Schirmer I test ≤ 5 mm and ≥ 2mm
OSDI ≥ 22
Normal ophthalmic findings except dry eye syndrome, ametropia < 6 Dpt.
No administration of topical lubricants 24 hours before the screening examination

Exclusion Criteria

Presence of an ocular pathology judged by the investigator as incompatible with the study.
Any other clinical relevant ocular abnormality except DES.
History of allergy, known hypersensitivity to one of the components: the study medications or Fluorescein.
History of known clinically relevant allergy.
Medical or surgical history judged by the investigator to be incompatible with the study participation (hepatic or renal insufficiency; all chronic severe organic disease: metabolic, endocrine, neoplasic, haematological disease; severe psychiatric illness, etc.).
History of a recent acute illness with a recovery period within the 2 weeks before the inclusion visit (Day 0).
Pregnancy, lactation.
Pre-menopausal woman who is not using a reliable birth control method (oral contraceptives or coil) or is not surgically sterilised.
Participation in any high-speed or water-sports during the study without ocular protection (goggles or glasses).
Subject unable to understand the study instructions or unlikely to comply with the study schedule and treatment.
Participation in another clinical study in the 4 weeks before the start of the present study or at the same time as the present study.
Subject is a ward of court.

Study & Design

Arm && Interventions

Group	Intervention	Description
Experimental: Patients with dry eye syndrome 1	Thealoz Duo Eye Drops	40 Patients with dry eye syndrome
Experimental: Patients with dry eye syndrome 3	Systane Ultra Eye Drops	40 Patients with dry eye syndrome
Experimental: Patients with dry eye syndrome 2	Optive Eye Drops	40 Patients with dry eye syndrome

Primary Outcome Measures

Name	Time	Method
Change in tear film thickness as measured with Optical Coherence Tomography (OCT)	10 weeks; at baseline, 10 minutes, 20 minutes, 40 minutes, 60 minutes, 120 minutes and 240 minutes after instillation of eye drops as well as 4 weeks and 8 weeks after the first instillation	Tear film thickness as measured with Optical Coherence Tomography (OCT) predose and at defined time points after the first instillation, as well as on each study day

Secondary Outcome Measures

Name	Time	Method
OSDI score	10 weeks
Subjective evaluation of ocular comfort with questionnaire	10 weeks
Corneal fluorescein staining (Oxford grading scale)	10 weeks
Tear Break Up Time (BUT)	10 weeks
Schirmer I test	10 weeks
Efficacy assessment of eye drops by the patient with questionnaire	10 weeks	Efficacy of eye drops will be performed by the patient by choosing one of the following options: * Very satisfactory * Satisfactory * Not very satisfactory * Unsatisfactory
Conjunctival hyperemia score	10 weeks
Efficacy assessment of eye drops by the investigator with questionnaire	10 weeks	Efficacy of eye drops will be performed by the investigator by choosing one of the following options: * Very satisfactory * Satisfactory * Not very satisfactory * Unsatisfactory

Recruitment & Eligibility