Dry EyeNCT06245421
Evaluation of the Efficacy and Safety of DM934 Versus Théalose on Eye Dryness
A study testing DM934 and Théalose in people with Dry Eye, run by Horus Pharma at 5 sites in 4 countries.
Trial 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 Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Dry Eye
- What is being tested?
- DM934 and Théalose
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 85 participants
- Where
- 5 sitesin 4 countries
- Study dates
- 7 Mar 2024to 30 Sep 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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:
Show all 12Show fewer
- 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.
Who cannot join
- 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
Show all 22Show fewer
- 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.
Trial locations and contacts
5 sites in 4 countries.
5 sites in 4 countries
About this study
Official title: 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
- Conditions
- Dry Eye
- Being tested
- DM934, Théalose
- Medical subject headings
- Dry Eye Syndromes
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DM934Device
1 drop in each eye, 4 to 6 times per day
ThéaloseDevice
1 drop in each eye, 4 to 6 times per day
| Study group | Role | What they receive |
|---|---|---|
| Investigational product | Experimental | Not described Receives: Device: DM934 |
| Comparator | Active comparator | Not described Receives: Device: Théalose |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 35 days
Secondary outcomes (17)
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
Measured: 35 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
Measured: 84 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
Measured: 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
Measured: 84 days
OSDI (questionnaire)(performance)
Main change from baseline of Ocular Surface Disease Index (OSDI) score
Measured: 35 days
OSDI (questionnaire)(performance)
Main change from baseline of Ocular Surface Disease Index (OSDI) score
Measured: 84 days
Van Bijsterveld score (performance)
Main change from baseline of Van Bijsterveld score (lissamine green staining) in the worse eye and contralateral eye
Measured: 35 days
Van Bijsterveld score (performance)
Main change from baseline of Van Bijsterveld score (lissamine green staining) in the worse eye and contralateral eye
Measured: 84 days
Schirmer test (performance)
Main change from baseline of Schirmer test result in the worse eye and contralateral eye
Measured: 35 days
Schirmer test (performance)
Main change from baseline of Schirmer test result in the worse eye and contralateral eye
Measured: 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
Measured: 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
Measured: 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)
Measured: 35 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)
Measured: 84 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)
Measured: 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)
Measured: 84 days
Number of Adverse Events (safety)
Collection of ocular and systemic adverse events
Measured: 84 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Feb 2024
- Study start7 Mar 2024
- Primary completion12 Aug 2024
- Study completion30 Sep 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Dry EyeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 85 participants (actual)
Sponsor and investigators
- Lead sponsor
- Horus Pharma
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Eurofins Dermscan Pharmascan
- Responsible party
- Sponsor
- Investigators
- Ewa Paw, MD, Principal investigator, Eurofins Dermscan Poland
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06245421
- Sponsor's protocol ID
- 23E0548
- Status last verified
- Jul 2024
- First submitted
- 30 Jan 2024
- Last updated
- 13 Feb 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: Depending on any journal publication of the results
Study at a glance
From the registry record, last updated by the sponsor on 13 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT06245421
- Acronym / sponsor ID
- 23E0548
- Conditions
- Dry Eye
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 85 participants (actual)
- Lead sponsor
- Horus PharmaIndustry (pharma, biotech, devices)
- Collaborators
- Eurofins Dermscan Pharmascan
- Study start
- 7 Mar 2024 (actual)
- Primary completion
- 12 Aug 2024 (actual)
- Study completion
- 30 Sep 2024 (actual)
- First posted
- 7 Feb 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Investigational product | Experimental | Device: DM934 |
| Comparator | Active comparator | Device: Théalose |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- 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:
- Schirmer test ≥ 3 mm/5 min and ≤ 9 mm/5 min OR
Key exclusion criteria (22 listed)
- Far best corrected visual acuity < 1/10 (according to Snellen Chart)
- Subject with severe ocular dryness with one of these conditions:
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| DM9341 drop in each eye, 4 to 6 times per day | Device | Investigational product |
| Théalose1 drop in each eye, 4 to 6 times per day | Device | Comparator |
Primary outcome
Cornea and conjunctiva staining (Oxford score)
Time frame: 35 days
Evaluation of the non-inferiority of DM934 in comparison with Théalose, in terms of cornea and conjunctiva staining (Oxford score), on worse eye
17 secondary outcomes
Cornea and conjunctiva staining (Oxford score) (performance)
Time frame: 35 days
Cornea and conjunctiva staining (Oxford score) (performance)
Time frame: 84 days
Tear-Film Break Up Time (TBUT) (performance)
Time frame: 35 days
Tear-Film Break Up Time (TBUT) (performance)
Time frame: 84 days
OSDI (questionnaire)(performance)
Time frame: 35 days
OSDI (questionnaire)(performance)
Time frame: 84 days
Van Bijsterveld score (performance)
Time frame: 35 days
Van Bijsterveld score (performance)
Time frame: 84 days
Schirmer test (performance)
Time frame: 35 days
Schirmer test (performance)
Time frame: 84 days
Dry eye symptoms (performance)
Time frame: 35 days
Dry eye symptoms (performance)
Time frame: 84 days
Global performance by the investigator (performance)
Time frame: 35 days
Global performance by the investigator (performance)
Time frame: 84 days
Global performance by the patient (performance)
Time frame: 35 days
Global performance by the patient (performance)
Time frame: 84 days
Number of Adverse Events (safety)
Time frame: 84 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Feb 2025.
- Individual participant dataSharing planned: Undecided. Depending on any journal publication of the results
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ewa Paw, MD principal investigator
Eurofins Dermscan Poland
5 sites in 4 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing DM934 and Théalose in people with Dry Eye, run by Horus Pharma at 5 sites in 4 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 12 inclusion and 22 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 13 Feb 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in France, Poland, Spain, United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Cornea and conjunctiva staining (Oxford score) (time frame: 35 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Feb 2025.