BridgeMD
Compares treatment options for Dry Eye
Official 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
ClinicalTrials.gov ID: NCT07593885
What this study is testing
What is Artelac® Complete MDO® Eye Drops?
Artelac® Complete MDO® Eye Drops is an investigational medicine, being studied as a potential treatment for dry eye.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- 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...
- 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...
- Subject with dry eye disease (DED) secondary to Sjögren's disease with clear functional disorders or people with epidermolysis bullosa, or ocular...
- Have a total OSDI score ≥ 23 at Visit 0 (Screening) and Visit 1 (Randomization)
You likely can't join if
- 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...
- Subject with known hypersensitivity or contraindications to any of the ingredients in the study or comparator products or ART, (especially...
- Subject with initiation of, or changes to, concomitant treatments that could affect dry eye within 30 days prior to Visit 0 (Screening) or with...
- Subject with initiation of, or changes to topical glucocorticoid and doxycycline treatments that could affect dry eye within 30 days prior to Visit 0...
See the full eligibility criteria
- 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...
- 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®) at least 3 times a day for at least 10...
- Subject with dry eye disease (DED) secondary to Sjögren's disease with clear functional disorders or people with epidermolysis bullosa, or ocular pemphigoid, absence or damage to the lacrimal gland, facial paralysis or...
- 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:
- 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...
- 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...
- 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...
- 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...
- 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 assigned by chance 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...
- 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...
The study team makes the final eligibility decision.
Where it's taking place
- Heidelberg, Baden-Wurttemberg, Germany
- Bad Endorf, Bavaria, Germany
- Nuremberg, Bavaria, Germany
- Ahaus, North Rhine-Westphalia, Germany
- Homburg, Saarland, Germany
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Heidelberg, Baden-Wurttemberg, Germany; Bad Endorf, Bavaria, Germany; Nuremberg, Bavaria, Germany; Ahaus, North Rhine-Westphalia, Germany; Homburg, Saarland, Germany. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.