Dry EyeNCT07593885
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
A study testing Artelac® Complete MDO® Eye Drops and VISMED® MULTI Eye Drops in people with Dry Eye, run by Dr. Gerhard Mann chem.-pharm. Fabrik GmbH at 12 sites in Germany.
Trial 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 Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Dry Eye
- What is being tested?
- Artelac® Complete MDO® Eye Drops and VISMED® MULTI Eye Drops
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 160 participants
- Where
- 12 sitesGermany
- Study dates
- 30 Apr 2026to Nov 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
- Subject who is able and willing to comply with all treatment and follow-up/study procedures.
- 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®) for at least 10 days (± 3 days) immediately prior to randomization. All previously used tear substitutes will be discontinued at Visit 0 (Screening).
- 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.
- Have a total OSDI score ≥ 23 at Visit 0 (Screening) and Visit 1 (Randomization)
- Subject with at least 1 eye with the following signs of moderate to severe DED:
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- TFBUT of < 10sec (mean of 2 measurements) at both Visit 0 (Screening) and Visit 1 (Randomization).
- 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.
- If the subject is female, must not be breastfeeding and must fall into 1 of the following categories:
- 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).
Who cannot join
- Ocular Exclusion Criteria
- Subject who has received ocular surgery, including laser surgery, intraocular injections in either eye within 90 days prior to study start.
- Subject with acute ocular trauma, acute (non-dry eye) ocular inflammation, or acute ocular infection in either eye within 45 days prior to study start.
- Treatment Exclusion Criteria
- Subject with known hypersensitivity or contraindications to any of the ingredients in the study or comparator products or ART, (especially, hyaluronic acid, glycerol, Myritol and carbomer)
- Subject with initiation of, or changes to, concomitant treatments that could affect dry eye within 30 days prior to Visit 0 (Screening) or with planned initiation, changes of such treatments during the study unless the investigator considers it clinically irrelevant.
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- Subject with initiation of, or changes to topical glucocorticoid and doxycycline treatments that could affect dry eye within 30 days prior to Visit 0 (Screening) or with planned initiation or changes of such medications during the study unless the investigator considers it clinically irrelevant.
- Subject with initiation of, or changes to, topical cyclosporine that could affect dry eye within 90 days prior to Visit 0 (Screening), or with planned initiation or changes of such medications during the study
- Subject that is using or used serum or plasma derived eye drops within three months before start of screening.
- Subject have used an investigational drug or device within 30 days of Visit 0 (Screening) or be concurrently enrolled in another investigational drug or device study.
- Subject has previously been randomized in the present Study BL-CO04-ARTLCOMP-1401.
- The subject has a condition or is in a situation that, in the Investigator's opinion, may put the subject at significant risk, may confound the study results, or may interfere significantly with the subject's participation in the study.
- Vulnerable subject who is unable to fully understand all aspects of the investigation that are relevant to the decision to participate, or who could be manipulated or unduly influenced as a result of a compromised position, expectation of benefits or fear of retaliatory response.
Trial locations and contacts
12 sites in 1 country. Contact the study team or a site near you to ask about taking part.
12 sites in 1 country
Germany12 sites, 12 recruiting
- Recruiting
Augen-Zentrum-Nordwest
Ahaus, North Rhine-Westphalia, 48683
- Not yet recruiting
Medizinisches Versorungszentrum AR Augenblick Rheinland GmbH
Brühl, North Rhine-Westphalia, 50321
- Not yet recruiting
University Eye Clinic Cologne
Cologne, North Rhine-Westphalia, 50937
- Not yet recruiting
Klinik für Augenheilkunde / Universitätsklinikum Düsseldorf
Düsseldorf, North Rhine-Westphalia, 40225
- Recruiting
Klinik für Augenheilkunde, Universitätklinikum Freiburg
Freiburg im Breisgau, Baden-Wurttemberg, 79106
- Recruiting
Universitäts-Augenklinik Heidelberg
Heidelberg, Baden-Wurttemberg, 69120
- Recruiting
University Saarland Medical Center
Homburg, Saarland, 66421
- Recruiting
Department of Ophthalmology, University Medical Center, Johannes Gutenberg-University Mainz
Mainz, Rhineland-Palatinate, 55131
- Recruiting
Department of Ophthalmology, Ludwig Maximilian University
Munich, Bavaria, 80337
- Recruiting
Augen & Haut Zentrum-Praxis Dr. Jacobi
Nuremberg, Bavaria, 90403
- Recruiting
Chiemsee Augentagesklinik, Prien
Prien am Chiemsee, Bavaria, 83209
- Recruiting
Universitätsklinikum Tübingen, Department für Augenheilkunde
Tübingen, Baden-Wurttemberg, 72074
About this study
Official title: 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
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
- Conditions
- Dry Eye
- Being tested
- Artelac® Complete MDO® Eye Drops, VISMED® MULTI Eye Drops
- Medical subject headings
- Dry Eye Syndromes
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Artelac® Complete MDO® Eye DropsDrug
Self-administered eye drops
VISMED® MULTI Eye DropsDrug
Self-administered eye drops
| Study group | Role | What they receive |
|---|---|---|
| Artelac® Complete MDO® Eye Drops | Experimental | Not described Receives: Drug: Artelac® Complete MDO® Eye Drops |
| VISMED® MULTI Eye Drops | Active comparator | Not described Receives: Drug: VISMED® MULTI Eye Drops |
What is being measured
The primary outcome is the main question the study is designed to answer.
The primary performance endpoint for this study is change from baseline (CFB) at Visit 3 (Day 90) in total OSDI score.
Measured: Assessed at Visit 3 (Day 90)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 May 2026
- Study start30 Apr 2026
- Primary completionNov 2026 (estimated)
- Study completionNov 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Dry EyeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 160 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Dr. Gerhard Mann chem.-pharm. Fabrik GmbH
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07593885
- Sponsor's protocol ID
- BL-CO04-ARTLCOMP-1401
- Status last verified
- Sep 2026
- First submitted
- 12 May 2026
- Last updated
- 30 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT07593885
- Acronym / sponsor ID
- BL-CO04-ARTLCOMP-1401
- Conditions
- Dry Eye
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 160 participants (estimated)
- Lead sponsor
- Dr. Gerhard Mann chem.-pharm. Fabrik GmbHIndustry (pharma, biotech, devices)
- Study start
- 30 Apr 2026 (actual)
- Primary completion
- Nov 2026 (estimated)
- Study completion
- Nov 2026 (estimated)
- First posted
- 18 May 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Artelac® Complete MDO® Eye Drops | Experimental | Drug: Artelac® Complete MDO® Eye Drops |
| VISMED® MULTI Eye Drops | Active comparator | Drug: VISMED® MULTI Eye Drops |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- 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.
- Subject who is able and willing to comply with all treatment and follow-up/study procedures.
- 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®) for at least 10 days (± 3 days) immediately prior to randomization. All previously used tear substitutes will be discontinued at Visit 0 (Screening).
- 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.
- Have a total OSDI score ≥ 23 at Visit 0 (Screening) and Visit 1 (Randomization)
Key exclusion criteria (13 listed)
- Ocular Exclusion Criteria
- Subject who has received ocular surgery, including laser surgery, intraocular injections in either eye within 90 days prior to study start.
- Subject with acute ocular trauma, acute (non-dry eye) ocular inflammation, or acute ocular infection in either eye within 45 days prior to study start.
- Treatment Exclusion Criteria
- Subject with known hypersensitivity or contraindications to any of the ingredients in the study or comparator products or ART, (especially, hyaluronic acid, glycerol, Myritol and carbomer)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Artelac® Complete MDO® Eye DropsSelf-administered eye drops | Drug | Artelac® Complete MDO® Eye Drops |
| VISMED® MULTI Eye DropsSelf-administered eye drops | Drug | VISMED® MULTI Eye Drops |
Primary outcome
The primary performance endpoint for this study is change from baseline (CFB) at Visit 3 (Day 90) in total OSDI score.
Time frame: Assessed at Visit 3 (Day 90)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Sep 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
12 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Artelac® Complete MDO® Eye Drops and VISMED® MULTI Eye Drops in people with Dry Eye, run by Dr. Gerhard Mann chem.-pharm. Fabrik GmbH at 12 sites in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 30 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 12 sites in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Natasa Orlic-Pleyer (03033093318, natasa.orlic-pleyer@bausch.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The primary performance endpoint for this study is change from baseline (CFB) at Visit 3 (Day 90) in total OSDI score. (time frame: Assessed at Visit 3 (Day 90)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Sep 2026.