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

Официальное название

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

Обзор

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

Вмешательства

• Препарат Artelac® Complete MDO® Eye Drops
  Self-administered eye drops
• Препарат VISMED® MULTI Eye Drops
  Self-administered eye drops

Первичные конечные точки

• The primary performance endpoint for this study is change from baseline (CFB) at Visit 3 (Day 90) in total OSDI score. [Срок оценки: Assessed at Visit 3 (Day 90)]

Критерии участия

Критерии включения

• 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®) 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).
• 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:

• 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 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).

Критерии исключения

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.
• 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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Двойное слепое

Основная цель

Лечение

Центры проведения

Германия · 5 центров

• Universitäts-Augenklinik Heidelberg — Heidelberg
• Chiemsee Augentagesklinik, Prien — Bad Endorf
• Augen & Haut Zentrum-Praxis Dr. Jacobi — Nuremberg
• Augen-Zentrum-Nordwest — Ahaus
• University Saarland Medical Center — Homburg

Идентификаторы

NCT: NCT07593885 · BL-CO04-ARTLCOMP-1401

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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