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

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

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.

Study Overview

• Status: Completed
• Conditions: Dry Eye
• Intervention / Treatment: Device: DM-28

• Study Type: Interventional
• Enrollment (Actual): 44
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Poland
  • Gdańsk, Poland
    • Eurofins Dermscan Poland
  • Gdańsk, Poland
    • Tu sie Leczy

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Investigational Product	Device: DM-28; 1 drop in each eye, 4 to 6 times per day

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Far best corrected visual acuity (FBCVA)	Change from baseline of FBCVA	Day 35
General safety	Collection and description of ocular and systemic Adverse Events	Day 35
Cornea and conjunctiva staining (Oxford scale)	Main change from baseline of cornea and conjunctiva staining (Oxford scale from 0 to 15, 15 meaning a worse outcome) in the contralateral eye	Day 35
OSDI (questionnaire)	Main change from baseline of Ocular Surface Disease Index (OSDI) score	Day 35
Schirmer test	Main change from baseline of Schirmer test result in the worse eye and contralateral eye	Day 35
Tear-Film Break Up Time (TBUT)	Main change from baseline of Tear-Film Break Up Time (TBUT) in the worse eye and contralateral eye	Day 35
Conjunctival hyperaemia	Main change from baseline of conjunctival hyperaemia using the McMonnies scale (from 0 to 5, 5 meaning a worse outcome) in the worse eye and contralateral eye	Day 35
Global performance by the investigator	Global performance assessment by the investigator using a 4-point scale (Unsatisfactory, Not very satisfactory, Satisfactory, Very satisfactory)	Day 35
Global performance by the patient	Global performance assessment by the patient using a 4-point scale (Unsatisfactory, Not very satisfactory, Satisfactory, Very satisfactory)	Day 35
Comfort upon device administration	Evaluation of the comfort upon device administration by the patient using a 5-points scale (from very uncomfortable to very comfortable)	Day 4, Day 11, Day 18, Day 25, Day 32
Patient satisfaction on device performance	Evaluation of patient satisfaction on 5 Visual Analogical Scales (VAS) from 0 to 100 and calculation of the total score	Day 0, Day 7, Day 14, Day 21, Day 28, Day 35

Collaborators and Investigators

• Sponsor: Horus Pharma
• Collaborators: Eurofins Dermscan Pharmascan
• Investigators: Principal Investigator: Ewa Paw, MD, Eurofins Dermscan Poland

Study record dates

Study Major Dates

• Study Start (Actual): September 26, 2024
• Primary Completion (Actual): January 9, 2025
• Study Completion (Actual): January 9, 2025

Study Registration Dates

• First Submitted: September 9, 2024
• First Submitted That Met QC Criteria: September 18, 2024
• First Posted (Actual): September 23, 2024

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: February 11, 2025
• Last Verified: February 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Eye Diseases; Lacrimal Apparatus Diseases; Dry Eye Syndromes
• Other Study ID Numbers: 23E2474

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED
• IPD Plan Description: Depending on any journal publication of the results

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No