Dry eye disease Eye Diseases Other disorders of lacrimal gland
Conditions
Interventions
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
Sponsors
URSAPHARM (Germany)
Eligibility
Sex/Gender
All
Inclusion criteria
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
Exclusion criteria
Exclusion criteria: 1. Change of therapeutic (pharmacological) ophthalmic or systemic agents and dosage within the last 3 months and during the course of the study 2. Ocular operations within the last 3 months 3. Eyelid misalignment and/or lagophthalmos 4. Use of punctum plugs within the last 3 months 5. Contact lens wearers 6. Hypersensitivity to any of the ingredients 7. The patient is pregnant or breastfeeding 8. The patient is a woman of childbearing age without regular and correct use of a contraceptive method with an error rate of <1% (e.g. sexual abstinence, contraceptives containing estrogen and gestagen, vasectomy, intrauterine device with hormones) 9. Simultaneous participation in a clinical trial or in another clinical trial within the last 4 weeks 10. Previous participation in this study or the patient is the investigator or a member of the staff involved in the study 11. Inability to understand the written patient information linguistically and/or in terms of content
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Non-invasive Tear Break Up Time (NIBUT) measured using a Scheimpflug camera at day 1 and day 28±3 | — |
Secondary
| Measure | Time frame |
|---|---|
| 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 | — |
Countries
Sweden
Outcome results
None listed