Evaporative dry eye and meibomian gland dysfunction Eye Diseases Other disorders of lacrimal gland
Conditions
Interventions
Screening comprises 30 patients with evaporative dry eye disease and mild to moderate meibomian gland dysfunction. 30 patients are included and treated (10 patients per treatment group). The three gro
Sponsors
URSAPHARM Arzneimittel GmbH
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Male and female patients aged > 18 years 2. Patients with evaporative dry eye and mild to moderate meibomian gland dysfunction: 2.1. Hyposecretion and reduced manual expression of meibomian glands 2.2. NIBUT = 10 s 2.3. Staining of the ocular surface: = 4 and = 9 points on the Oxford grading scale (15 points max) 3. Subjective feeling of evaporative dry eye discomfort more than 3 months 3.1. Visual analogue scale (VAS) = 2/10 3.2. OSDI = 15 4. Stable therapy (topical and systemic) = 4 weeks 5. Patient willing and being able to fulfil the requirements of the trial protocol
Exclusion criteria
Exclusion criteria: 1. Dry eye due to systemic disease, concomitant medication, malign conditions or idiopathic causes 2. History of ocular surgery during the past 3 months 3. Malposition of the lids and/or lagophthalmos 4. Punctum plugs during the past 3 months 5. Contact lens wearers 6. Use of lipid-containing eye drops during the past 3 months 7. Use of other therapeutic ophthalmics during the past 3 months 8. Sensitivity against any of the ingredients 9. Patient pregnant or breastfeeding 10. Women with childbearing potential without regular and correct use of contraception with an error rate < 1% (e.g. sexual abstinence, estrogen and gestagen containing contraceptives, vasectomy, intrauterine pessary with hormones) 11. Concomitant clinical trial participation within the last 4 weeks 12. Earlier participation at this clinical trial or the patient being an investigator or a member of the personnel involved at this clinical trial 13. Inability to understand written patient information
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Non-invasive Tear Break Up Time (NIBUT) measured using Dry Eye Monitor (KOWA DR-1 a) at day 1, day 7 ±2 and day 28 ±2 | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Subjective discomfort feeling measured using a questionnaire (VAS/OSDI) at day 1, day 7 ±2 and day 28 ±2 2. Visual acuity (VA) measured by refraction at day 1, day 7 ±2 and day 28 ±2 3. Thickness of lipid layer (LLT) measured using LipiView at day 1, day 7 ±2 and day 28 ±2 4. Examination of eyelids, conjunctiva, and cornea using slit lamp at day 1, day 7 ±2 and day 28 ±2 as follows: 4.1. Assessment of eyelid margin (redness, secretion, manual expression of meibomian glands) 4.2. Conjunctival hyperemia 4.3. LIPCOF 4.4. Corneal staining with fluorescein 5. Intraocular pressure (IOP) measured using tonometry at day 1, day 7 ±2 and day 28 ±2 6. Subjective assessment of tolerability by the patient using interview at day 28 ±2 7. Evaluation of efficacy and tolerability by the investigator using interview at day 28 ±2 | — |
Countries
Germany
Outcome results
None listed