Dry Eye
Conditions
Brief summary
A Double-Masked, Randomized, Parallel Group, Non-Inferiority Study to Evaluate the Performance and Safety of Artelac® Complete MDO® Versus VISMED® MULTI Eye Drops in the Management of Moderate to Severe Dry Eye Disease
Interventions
Self-administered eye drops
DRUGArtelac® Complete MDO® Eye Drops
Self-administered eye drops
Sponsors
Dr. Gerhard Mann chem.-pharm. Fabrik GmbH
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Subject must be of legal age (at least 18) on the date the Informed Consent Form (ICF) is signed and must be able to read, understand, and provide written voluntary informed consent on the Ethics Committee (EC) approved ICF. 2. Subject who is able and willing to comply with all treatment and follow-up/study procedures. 3. Subject who have a history of using tear substitutes for at least 1 month prior to Visit 0 (Screening), and who will use preservative-free tear substitute (Artelac® Splash MDO®) at least 3 times a day for at least 10 days (± 3 days) immediately prior to randomization. All previously used tear substitutes will be discontinued at Visit 0 (Screening). 4. Subject with dry eye disease (DED) secondary to Sjögren's disease with clear functional disorders or subjects with epidermolysis bullosa, or ocular pemphigoid, absence or damage to the lacrimal gland, facial paralysis or lagophthalmos requiring use of tear substitutes. 5. Have a total OSDI score ≥ 23 at Visit 0 (Screening) and Visit 1 (Randomization) 6. Subject with at least 1 eye with the following signs of moderate to severe DED: 1. TFBUT of \< 10sec (mean of 2 measurements) at both Visit 0 (Screening) and Visit 1 (Randomization). 2. Total ocular surface staining score ≥ 4 at both Visit 0 (Screening) and Visit 1 (Randomization). This assessment combines corneal, nasal, and temporal bulbar conjunctival fluorescein staining, each graded 0-5 according to the Oxford Scheme. 7. If the subject is female, must fall into 1 of the following categories: a. Post-menopausal (12 months after last menses) b. Surgically sterile c. Using one of the following birth control methods throughout the duration of the study: i. Intrauterine device (inserted at least 14 days prior to Visit 0 \[Screening\]) ii. Barrier method (condom or diaphragm) with spermicide (at least 14 days prior to Visit 0 \[Screening\]) iii. Hormonal contraception (stable dose and formulation for at least 6 months prior to Visit 0 \[Screening\]) iv. Abstinence (if this is in alignment with the lifestyle of the subject) Female subject who are of childbearing potential (i.e., who are not post-menopausal or not surgically sterile), must have a negative urine pregnancy test result at Visit 0 (Screening).
Exclusion criteria
Ocular
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The primary performance endpoint for this study is change from baseline (CFB) at Visit 3 (Day 90) in total OSDI score. | Assessed at Visit 3 (Day 90) |
Countries
Germany
Contacts
CONTACTNatasa Orlic-Pleyer
Outcome results
None listed