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

Last updated: February 11, 2025
Sponsor: Horus Pharma
Overall Status: Completed

Phase

N/A

Condition

N/A

Treatment

DM934

Théalose

Clinical Study ID

NCT06245421
23E0548
  • Ages > 18
  • All Genders

Study Summary

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

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Subject with a moderate to severe dry eye syndrome needing artificial tears in the 3months 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 duringwash-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 thepresent CIP, at the Investigator's appreciation.

  • For applicable countries: subject being affiliated to a health social securitysystem.

  • Female subjects of childbearing potential should use a medically acceptedcontraceptive regimen since at least 12 weeks before the beginning of thestudy, during all the study and at least 1 month after the study end.

Exclusion

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 syndromewithin 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 withinthe 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 ophthalmicmedication, except tear substitutes, within 2 weeks prior to study start or expectedto receive ocular therapy during the study.

  • Any not stabilised systemic treatment, which can have an effect on performance orsafety 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 Design

Total Participants: 85
Treatment Group(s): 2
Primary Treatment: DM934
Phase:
Study Start date:
March 07, 2024
Estimated Completion Date:
September 30, 2024

Connect with a study center

  • Eurofins Dermscan

    Aix-en-Provence,
    France

    Site Not Available

  • Eurofins EVIC

    Bordeaux,
    France

    Site Not Available

  • Eurofins Dermscan Poland

    Gdańsk,
    Poland

    Site Not Available

  • IOBA

    Valladolid,
    Spain

    Site Not Available

  • Ocular Technology Group

    London,
    United Kingdom

    Site Not Available

Not the study for you?

Let us help you find the best match. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.