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

Not Applicable

Completed

• Conditions: Dry Eye
• Interventions: Device: DM-28

• Registration Number: NCT06607237
• Lead Sponsor: Horus Pharma

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2024-09-09
• Study First Submitted QC: 2024-09-18
• Study First Posted: 2024-09-23
• Study Start: 2024-09-26
• Primary Completion: 2025-01-09
• Study Completion: 2025-01-09
• Status Verified: 2025-02
• Last Update Submitted: 2025-02-11
• Last Update Posted: 2025-02-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 44

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Investigational Product	DM-28	-

Primary Outcome Measures

Name	Time	Method
Incidence of adverse device effects	Day 35	Adverse device effects will be evaluated via ocular examination and ocular symptoms after instillation reported by the subjects
Cornea and conjunctiva staining (Oxford scale) (performance)	Day 35	Main change from baseline of cornea and conjunctiva staining (Oxford scale form 0 to 15, 15 meaning a worse outcome) in the worse eye

Secondary Outcome Measures

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

Trial Locations

Locations (2)

Eurofins Dermscan Poland; 🇵🇱 Gdańsk, Poland

Tu sie Leczy; 🇵🇱 Gdańsk, Poland