Dry EyeNCT06607237
Evaluation of Safety and Efficacy of DM-28 for Treatment of Moderate to Severe Ocular Dryness
A study testing DM-28 in people with Dry Eye, run by Horus Pharma at 2 sites in Poland.
Trial 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. 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?
- DM-28
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 44 participants
- Where
- 2 sitesPoland
- Study dates
- 26 Sep 2024to 9 Jan 2025
- 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.
- 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
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- 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).
Who cannot join
- 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
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- 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
Trial locations and contacts
2 sites in 1 country.
About this study
Official title: Prospective, Single Arm, Open-label Clinical Investigation on the Evaluation of Safety and Efficacy of DM-28 for Treatment of Moderate to Severe Ocular Dryness
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.
- Conditions
- Dry Eye
- Being tested
- DM-28
- 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.
DM-28Device
1 drop in each eye, 4 to 6 times per day
| Study group | Role | What they receive |
|---|---|---|
| Investigational Product | Experimental | Not described Receives: Device: DM-28 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of adverse device effects
Adverse device effects will be evaluated via ocular examination and ocular symptoms after instillation reported by the subjects
Measured: Day 35
Cornea and conjunctiva staining (Oxford scale) (performance)
Main change from baseline of cornea and conjunctiva staining (Oxford scale form 0 to 15, 15 meaning a worse outcome) in the worse eye
Measured: Day 35
Secondary outcomes (11)
Far best corrected visual acuity (FBCVA)
Change from baseline of FBCVA
Measured: Day 35
General safety
Collection and description of ocular and systemic Adverse Events
Measured: Day 35
Cornea and conjunctiva staining (Oxford scale)
Main change from baseline of cornea and conjunctiva staining (Oxford scale from 0 to 15, 15 meaning a worse outcome) in the contralateral eye
Measured: Day 35
OSDI (questionnaire)
Main change from baseline of Ocular Surface Disease Index (OSDI) score
Measured: Day 35
Schirmer test
Main change from baseline of Schirmer test result in the worse eye and contralateral eye
Measured: Day 35
Tear-Film Break Up Time (TBUT)
Main change from baseline of Tear-Film Break Up Time (TBUT) in the worse eye and contralateral eye
Measured: Day 35
Conjunctival hyperaemia
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
Measured: Day 35
Global performance by the investigator
Global performance assessment by the investigator using a 4-point scale (Unsatisfactory, Not very satisfactory, Satisfactory, Very satisfactory)
Measured: Day 35
Global performance by the patient
Global performance assessment by the patient using a 4-point scale (Unsatisfactory, Not very satisfactory, Satisfactory, Very satisfactory)
Measured: Day 35
Comfort upon device administration
Evaluation of the comfort upon device administration by the patient using a 5-points scale (from very uncomfortable to very comfortable)
Measured: Day 4, Day 11, Day 18, Day 25, Day 32
Patient satisfaction on device performance
Evaluation of patient satisfaction on 5 Visual Analogical Scales (VAS) from 0 to 100 and calculation of the total score
Measured: Day 0, Day 7, Day 14, Day 21, Day 28, Day 35
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Sep 2024
- Study start26 Sep 2024
- Primary completion9 Jan 2025
- Study completion9 Jan 2025
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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 44 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
- NCT06607237
- Sponsor's protocol ID
- 23E2474
- Status last verified
- Feb 2025
- First submitted
- 9 Sep 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
- Prospective, Single Arm, Open-label Clinical Investigation on the Evaluation of Safety and Efficacy of DM-28 for Treatment of Moderate to Severe Ocular Dryness
- ClinicalTrials.gov ID
- NCT06607237
- Acronym / sponsor ID
- 23E2474
- Conditions
- Dry Eye
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 44 participants (actual)
- Lead sponsor
- Horus PharmaIndustry (pharma, biotech, devices)
- Collaborators
- Eurofins Dermscan Pharmascan
- Study start
- 26 Sep 2024 (actual)
- Primary completion
- 9 Jan 2025 (actual)
- Study completion
- 9 Jan 2025 (actual)
- First posted
- 23 Sep 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 pilot, exploratory study to check safety and efficacy of DM-28 device, a new medical device intended to treat moderate to severe ocular dryness.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Investigational Product | Experimental | Device: DM-28 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- 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:
- Schirmer test ≥ 3 mm/5 min and ≤ 9 mm/5 min OR
- Sum of 3 measurements of Tear film Break-Up Time (TBUT) ≤ 30s.
Key exclusion criteria (23 listed)
- Far best corrected visual acuity (FBCVA) < 1/10 (according to Snellen Chart)
- Subject with severe ocular dryness with one of these conditions (investigator expertise):
- 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 |
|---|---|---|
| DM-281 drop in each eye, 4 to 6 times per day | Device | Investigational Product |
Primary outcome
Incidence of adverse device effects
Time frame: 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)
Time frame: 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
11 secondary outcomes
Far best corrected visual acuity (FBCVA)
Time frame: Day 35
General safety
Time frame: Day 35
Cornea and conjunctiva staining (Oxford scale)
Time frame: Day 35
OSDI (questionnaire)
Time frame: Day 35
Schirmer test
Time frame: Day 35
Tear-Film Break Up Time (TBUT)
Time frame: Day 35
Conjunctival hyperaemia
Time frame: Day 35
Global performance by the investigator
Time frame: Day 35
Global performance by the patient
Time frame: Day 35
Comfort upon device administration
Time frame: Day 4, Day 11, Day 18, Day 25, Day 32
Patient satisfaction on device performance
Time frame: Day 0, Day 7, Day 14, Day 21, Day 28, Day 35
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
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing DM-28 in people with Dry Eye, run by Horus Pharma at 2 sites in Poland.
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 11 inclusion and 23 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 2 sites in Poland. 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?
Incidence of adverse device effects (time frame: Day 35). The study lists 2 primary outcomes in all. 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.