Actively Recruiting
A Double-Masked, Randomized Study to Evaluate Performance and Safety of Artelac Complete MDO Versus VISMED MULTI Eye Drops for Moderate to Severe Dry Eye Disease
Led by Dr. Gerhard Mann chem.-pharm. Fabrik GmbH · Updated on 2026-05-18
160
Participants Needed
5
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are studying the management of moderate to severe dry eye disease by comparing two types of eye drops: Artelac Complete MDO and VISMED MULTI. The study aims to evaluate the performance and safety of these treatments. It is a double-masked, randomized, parallel group, non-inferiority study sponsored by Dr. Gerhard Mann chem.-pharm. Fabrik GmbH. Participants will self-administer either Artelac Complete MDO eye drops or VISMED MULTI eye drops. The study involves a treatment period leading to a key assessment at Day 90 (Visit 3). Before randomization, participants will use a preservative-free tear substitute at least three times daily for around 10 days. The study compares the two treatments by measuring eye health and dry eye symptoms over time. During the study, participants will have their dry eye symptoms evaluated using the Ocular Surface Disease Index (OSDI) score at baseline and Day 90. Other assessments include tear film break-up time and ocular surface staining at screening and randomization visits. The primary outcome is the change in total OSDI score after 90 days. Participants must comply with treatment and follow-up visits, which will monitor safety and treatment effects throughout the study duration.
CONDITIONS
Brief Title
A 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
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Must be 18 years or older and able to provide written informed consent
- Willing and able to comply with all treatment and follow-up procedures
- History of using tear substitute eye drops for at least 1 month prior to screening
- Will use preservative-free tear substitute at least 3 times daily for at least 10 days before randomization
- Diagnosed with dry eye disease secondary to specific conditions or requiring tear substitutes
- Total OSDI score of 23 or higher at screening and randomization visits
- At least one eye with tear film break-up time less than 10 seconds and ocular surface staining score of 4 or higher at screening and randomization
- Female participants must be post-menopausal, surgically sterile, or using approved birth control methods during the study
You will not qualify if you...
- Eye surgery or intraocular injections in either eye within 90 days before study start
- Acute eye trauma, inflammation, or infection within 45 days before study start
- Known allergy or contraindication to ingredients in study or comparator eye drops
- Recent or planned changes in treatments affecting dry eye within 30 days before screening or during the study
- Recent or planned use of topical glucocorticoids, doxycycline, or cyclosporine affecting dry eye within specified time frames
- Use of serum or plasma derived eye drops within 3 months before screening
- Participation in other investigational drug or device studies within 30 days before screening
- Previous randomization in this specific study
- Conditions or situations posing significant risk or interfering with study participation
- Vulnerable subjects unable to fully understand or consent to study participation
AI-Screening
AI-Powered Screening
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Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 90 days
Participants self-administer assigned eye drops to manage moderate to severe dry eye disease.
3 visits including baseline and follow-up assessments
Trial Site Locations
Total: 5 locations
1
Universitäts-Augenklinik Heidelberg
Heidelberg, Baden-Wurttemberg, Germany, 69120
Not Yet Recruiting
2
Chiemsee Augentagesklinik, Prien
Bad Endorf, Bavaria, Germany, 83093
Not Yet Recruiting
3
Augen & Haut Zentrum-Praxis Dr. Jacobi
Nuremberg, Bavaria, Germany, 90403
Actively Recruiting
4
Augen-Zentrum-Nordwest
Ahaus, North Rhine-Westphalia, Germany, 48683
Not Yet Recruiting
5
University Saarland Medical Center
Homburg, Saarland, Germany, 66421
Not Yet Recruiting
Research Team
N
Natasa Orlic-Pleyer
How is the study designed?
Study Type
INTERVENTIONAL
Masking
DOUBLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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