NCT06245421

Brief 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

Trial Health

90
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
85

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Mar 2024

Shorter than P25 for not_applicable

Geographic Reach
4 countries

5 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 30, 2024

Completed
8 days until next milestone

First Posted

Study publicly available on registry

February 7, 2024

Completed
29 days until next milestone

Study Start

First participant enrolled

March 7, 2024

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 12, 2024

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 30, 2024

Completed
Last Updated

February 13, 2025

Status Verified

July 1, 2024

Enrollment Period

5 months

First QC Date

January 30, 2024

Last Update Submit

February 11, 2025

Conditions

Dry Eye

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (17)

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

    35 days

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

    84 days

  • Tear-Film Break Up Time (TBUT) (performance)

    35 days

  • Tear-Film Break Up Time (TBUT) (performance)

    84 days

  • OSDI (questionnaire)(performance)

    35 days

  • +12 more secondary outcomes

Other Outcomes (2)

  • Lacrimal meniscus height (exploratory, optional)

    35 days

  • Lacrimal meniscus height (exploratory, optional)

    84 days

Study Arms (2)

Investigational product

EXPERIMENTAL
Device: DM934

Comparator

ACTIVE COMPARATOR
Device: Théalose

Interventions

DM934DEVICE

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

Investigational product
ThéaloseDEVICE

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

Comparator

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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 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.
  • 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.
  • +4 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (5)

Eurofins Dermscan

Aix-en-Provence, France

Location

Eurofins EVIC

Bordeaux, France

Location

Eurofins Dermscan Poland

Gdansk, Poland

Location

IOBA

Valladolid, Spain

Location

Ocular Technology Group

London, United Kingdom

Location

MeSH Terms

Conditions

Dry Eye Syndromes

Condition Hierarchy (Ancestors)

Lacrimal Apparatus DiseasesEye Diseases

Study Officials

  • Ewa Paw, MD

    Eurofins Dermscan Poland

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 30, 2024

First Posted

February 7, 2024

Study Start

March 7, 2024

Primary Completion

August 12, 2024

Study Completion

September 30, 2024

Last Updated

February 13, 2025

Record last verified: 2024-07

Locations

GB(1)FR(2)PL(1)ES(1)