Evaluation of Safety and Efficacy of DM-28 for Treatment of Moderate to Severe Ocular Dryness

NCT06607237 | Completed

• 1 other identifier: 23E2474
• Study Type: interventional
• Target: 44
• Locations: 1 country
• Sites: 2

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.

Conditions

Dry Eye

Outcome Measures

Primary Outcomes (2)

• Incidence of adverse device effects

  Adverse device effects will be evaluated via ocular examination and ocular symptoms after instillation reported by the subjects

  Day 35

• Cornea and conjunctiva staining (Oxford scale) (performance)

  Main change from baseline of cornea and conjunctiva staining (Oxford scale form 0 to 15, 15 meaning a worse outcome) in the worse eye

  Day 35

Secondary Outcomes (11)

• Far best corrected visual acuity (FBCVA)

  Day 35

• General safety

  Day 35

• Cornea and conjunctiva staining (Oxford scale)

  Day 35

• OSDI (questionnaire)

  Day 35

• Schirmer test

  Day 35

Study Arms (1)

Investigational Product

EXPERIMENTAL

Device: DM-28

Interventions

DM-28 DEVICE

1 drop in each eye, 4 to 6 times per day

Investigational Product

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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).

You may not qualify if:

• 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 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.
• 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).

Sponsors & Collaborators

• Horus Pharma: lead
• Eurofins Dermscan Pharmascan: collaborator

Study Sites (2)

Eurofins Dermscan Poland

Gdansk, Poland

Location

Tu sie Leczy

Gdansk, Poland

Location

MeSH Terms

Conditions

Dry Eye Syndromes

Condition Hierarchy (Ancestors)

Lacrimal Apparatus Diseases; Eye Diseases

Study Officials

• Ewa Paw, MD

  Eurofins Dermscan Poland

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 9, 2024
• First Posted: September 23, 2024
• Study Start: September 26, 2024
• Primary Completion: January 9, 2025
• Study Completion: January 9, 2025
• Last Updated: February 13, 2025

Record last verified: 2025-02

Locations

PL (2)