Evaluation of the Efficacy and Safety of DM934 Versus Théalose on Eye Dryness

Multicentric, Randomized, Comparative Clinical Study on the Evaluation of the Efficacy and Safety of DM934 Versus Théalose on the Treatment of Moderate to Severe Ocular Dryness

This study is a multicentric, comparative, randomized, investigator-blinded, parallel group study to demonstrate the non-inferiority of DM934 in comparison with Théalose in terms of cornea and conjunctiva staining (Oxford score) on patients with moderate to severe ocular dryness, after 35 days of treatment

Study Overview

• Status: Completed
• Conditions: Dry Eye
• Intervention / Treatment: Device: DM934; Device: Théalose

• Study Type: Interventional
• Enrollment (Actual): 85
• Phase: Not Applicable

Contacts and Locations

Study Locations

• France
  • Aix-en-Provence, France
    • Eurofins DERMSCAN
  • Bordeaux, France
    • Eurofins EVIC
• Poland
  • Gdańsk, Poland
    • Eurofins Dermscan Poland
• Spain
  • Valladolid, Spain
    • IOBA
• United Kingdom
  • London, United Kingdom
    • Ocular Technology Group

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 needing artificial tears in the 3 months preceding the inclusion.
• Subject having used only artificial tears without preservative (NaCl 0.9%, Larmabak®) during 1 to 2 weeks before inclusion (up to 6 times a day) (given during wash-out period).
• Subject with a score ≥ 18 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.
  • For applicable countries: 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.

Exclusion Criteria:

• Far best corrected visual acuity < 1/10 (according to Snellen Chart)

• Subject with severe ocular dryness with one of these conditions:

  • 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 .
• Subjects who underwent ocular surgery, including laser surgery, in either eye within the last 6 months.
• Use of the following ocular treatments: isotretinoïd, cyclosporine, tacrolimus, sirolimus, pimecrolimus, punctual plugs 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 stabilised 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 deprived of freedom by administrative or legal decision.
• Subject in a social or health institution.
• Subject who is under guardianship or who is not able to express his/her consent.
• Subject being in an exclusion period for a previous study.
• Subject suspected to be non-compliant according to the Investigator's judgment.
• Subject wearing contact lenses during the study.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Investigational product	Device: DM934; 1 drop in each eye, 4 to 6 times per day
Active Comparator: Comparator	Device: Théalose; 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
Cornea and conjunctiva staining (Oxford score)	Evaluation of the non-inferiority of DM934 in comparison with Théalose, in terms of cornea and conjunctiva staining (Oxford score), on worse eye	35 days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Tear-Film Break Up Time (TBUT) (performance)	Main change from baseline of Tear-Film Break Up Time (TBUT) in the worse eye and contralateral eye	84 days
Cornea and conjunctiva staining (Oxford score) (performance)	Main change from baseline of cornea and conjunctiva staining (Oxford score) in the worse eye and contralateral eye	84 days
Global performance by the investigator (performance)	Global performance assessment by the investigator using a 4-point scale (Unsatisfactory, Not very satisfactory, Satisfactory, Very satisfactory)	84 days
Cornea and conjunctiva staining (Oxford score) (performance)	Main change from baseline of cornea and conjunctiva staining (Oxford score) in the worse eye and contralateral eye	35 days
Tear-Film Break Up Time (TBUT) (performance)	Main change from baseline of Tear-Film Break Up Time (TBUT) in the worse eye and contralateral eye	35 days
OSDI (questionnaire)(performance)	Main change from baseline of Ocular Surface Disease Index (OSDI) score	35 days
OSDI (questionnaire)(performance)	Main change from baseline of Ocular Surface Disease Index (OSDI) score	84 days
Van Bijsterveld score (performance)	Main change from baseline of Van Bijsterveld score (lissamine green staining) in the worse eye and contralateral eye	35 days
Van Bijsterveld score (performance)	Main change from baseline of Van Bijsterveld score (lissamine green staining) in the worse eye and contralateral eye	84 days
Schirmer test (performance)	Main change from baseline of Schirmer test result in the worse eye and contralateral eye	35 days
Schirmer test (performance)	Main change from baseline of Schirmer test result in the worse eye and contralateral eye	84 days
Dry eye symptoms (performance)	Mean change from Baseline in the global sum score of dry eye symptoms at D84 : discomfort,burning, stinging,eye dryness sensation, itching,foreign body sensation,photophobia, blurred vision.Each graded from 0 to 10	35 days
Dry eye symptoms (performance)	Mean change from Baseline in the global sum score of dry eye symptoms at D84 : discomfort,burning, stinging,eye dryness sensation, itching,foreign body sensation,photophobia, blurred vision.Each graded from 0 to 10	84 days
Global performance by the investigator (performance)	Global performance assessment by the investigator using a 4-point scale (Unsatisfactory, Not very satisfactory, Satisfactory, Very satisfactory)	35 days
Global performance by the patient (performance)	Global performance assessment by the patient using a 4-point scale (Unsatisfactory, Not very satisfactory, Satisfactory, Very satisfactory)	35 days
Global performance by the patient (performance)	lobal performance assessment by the patient using a 4-point scale (Unsatisfactory, Not very satisfactory, Satisfactory, Very satisfactory)	84 days
Number of Adverse Events (safety)	Collection of ocular and systemic adverse events	84 days

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Lacrimal meniscus height (exploratory, optional)	Main change from baseline of lacrimal meniscus height in the worse eye and contralateral eye	35 days
Lacrimal meniscus height (exploratory, optional)	Main change from baseline of lacrimal meniscus height in the worse eye and contralateral eye	84 days

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): March 7, 2024
• Primary Completion (Actual): August 12, 2024
• Study Completion (Actual): September 30, 2024

Study Registration Dates

• First Submitted: January 30, 2024
• First Submitted That Met QC Criteria: January 30, 2024
• First Posted (Actual): February 7, 2024

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: February 11, 2025
• Last Verified: July 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Eye Diseases; Lacrimal Apparatus Diseases; Dry Eye Syndromes
• Other Study ID Numbers: 23E0548

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