Clinical trial NCT06607237: Evaluation of Safety and Efficacy of DM-28 for Treatment of Moderate to Severe Ocular Dryness
Official title: Prospective, Single Arm, Open-label Clinical Investigation on the Evaluation of Safety and Efficacy of DM-28 for Treatment of Moderate to Severe Ocular Dryness
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Dry Eye
Lead sponsor: Horus Pharma
Sponsor class: INDUSTRY
Collaborators: name: Eurofins Dermscan Pharmascan
First posted: 2024-09-23
Enrollment: 44
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This study is a pilot, exploratory study to check safety and efficacy of DM-28 device, a new medical device intended to treat moderate to severe ocular dryness.


Eligibility criteria: Inclusion Criteria:

* Subject with a moderate to severe dry eye syndrome.
* Subject with a score ≥ 23 for the OSDI (Ocular Surface Disease Index).
* Subject with at least one eye with:

  * Global ocular staining (cornea and conjunctiva) ≥4 and ≤9 on the Oxford scale (0 to 15)

AND one of the following criteria:

* Schirmer test ≥ 3 mm/5 min and ≤ 9 mm/5 min OR
* Sum of 3 measurements of Tear film Break-Up Time (TBUT) ≤ 30s.

  * Subject, having given freely and expressly his/her informed consent.
  * Subject who is able to comply with the study requirements, as defined in the present CIP, at the Investigator's appreciation (investigator expertise).
  * Subject being affiliated to a health social security system.
  * Female subjects of childbearing potential should use a medically accepted contraceptive regimen since at least 12 weeks before the beginning of the study, during all the study and at least 1 month after the study end (subject declaration).

Exclusion Criteria:

* Far best corrected visual acuity (FBCVA) \< 1/10 (according to Snellen Chart)
* Subject with severe ocular dryness with one of these conditions (investigator expertise):

  * Eyelid or blinking malfunction
  * Corneal disorders not related to dry eye syndrome
  * Ocular metaplasia
  * Filamentous keratitis
  * Corneal neovascularization
* Subject with severe meibomian gland dysfunction (MGD)
* History of ocular trauma, infection or inflammation, not related to dry eye syndrome within the last 3 months prior to the inclusion
* History of ocular allergy or ocular herpes within the last 12 months.
* Any troubles of the ocular surface not related to dry eye syndrome.
* Subject with hypersensitivity to one of the components of the investigational device.
* Subjects who underwent ocular surgery, including laser surgery, in either eye within the last 6 months.
* Use of the following systemic or ocular treatments: isotretinoïd, cyclosporine, tacrolimus, sirolimus, pimecrolimus, punctual plugs, corticoids or dry eye therapy (intense pulse light, stem cells) during the month preceding the inclusion.
* Subjects who have received ocular therapy (either eye) with any ophthalmic medication, except tear substitutes, within 2 weeks prior to study start or expected to receive ocular therapy during the study.
* Any not stabilized systemic treatment, which can have an effect on performance or safety criteria, at the investigator appreciation.
* Pregnant or nursing woman or planning a pregnancy during the study (subject declaration/ pregnancy test).
* Subject deprived of freedom by administrative or legal decision (subject declaration).
* Subject in a social or health institution (subject declaration).
* Subject who is under guardianship or who is not able to express his/her consent (subject declaration/ investigator expertise).
* Subject being in an exclusion period for a previous study (subject declaration).
* Subject suspected to be non-compliant according to the Investigator's judgment (investigator expertise).
* Subject wearing contact lenses during the study

Primary outcomes:
measure: Incidence of adverse device effects
timeFrame: Day 35
measure: Cornea and conjunctiva staining (Oxford scale) (performance)
timeFrame: Day 35
Secondary outcomes:
measure: Far best corrected visual acuity (FBCVA)
timeFrame: Day 35
measure: General safety
timeFrame: Day 35
measure: Cornea and conjunctiva staining (Oxford scale)
timeFrame: Day 35
measure: OSDI (questionnaire)
timeFrame: Day 35
measure: Schirmer test
timeFrame: Day 35
measure: Tear-Film Break Up Time (TBUT)
timeFrame: Day 35
measure: Conjunctival hyperaemia
timeFrame: Day 35
measure: Global performance by the investigator
timeFrame: Day 35
measure: Global performance by the patient
timeFrame: Day 35
measure: Comfort upon device administration
timeFrame: Day 4, Day 11, Day 18, Day 25, Day 32
measure: Patient satisfaction on device performance
timeFrame: Day 0, Day 7, Day 14, Day 21, Day 28, Day 35
Other outcomes:
Locations:
city: Gdańsk
country: Poland
facility: Eurofins Dermscan Poland
city: Gdańsk
country: Poland
facility: Tu sie Leczy
Study officials:
affiliation: Eurofins Dermscan Poland
name: Ewa Paw, MD
role: PRINCIPAL_INVESTIGATOR
References: