Status:
COMPLETED
Evaluation of Safety and Efficacy of DM-28 for Treatment of Moderate to Severe Ocular Dryness
Lead Sponsor:
Horus Pharma
Collaborating Sponsors:
Eurofins Dermscan Pharmascan
Conditions:
Dry Eye
Eligibility:
All Genders
18+ years
Phase:
NA
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
- 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
- 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
Key Trial Info
Start Date :
September 26 2024
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 9 2025
Estimated Enrollment :
44 Patients enrolled
Trial Details
Trial ID
NCT06607237
Start Date
September 26 2024
End Date
January 9 2025
Last Update
February 13 2025
Active Locations (2)
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1
Eurofins Dermscan Poland
Gdansk, Poland
2
Tu sie Leczy
Gdansk, Poland