Evaluation of Safety and Efficacy of DM-28 for Treatment of Moderate to Severe Ocular Dryness

February 11, 2025 updated by: Horus Pharma

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
44

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • Poland
      • Gdańsk, Poland
        • Eurofins Dermscan Poland
      • Gdańsk, Poland
        • Tu sie Leczy

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • 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

  • 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).

Exclusion Criteria:

  • 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
    • 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Investigational Product
Device: DM-28
1 drop in each eye, 4 to 6 times per day

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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
Day 35
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
Day 35

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Far best corrected visual acuity (FBCVA)
Time Frame: Day 35
Change from baseline of FBCVA
Day 35
General safety
Time Frame: Day 35
Collection and description of ocular and systemic Adverse Events
Day 35
Cornea and conjunctiva staining (Oxford scale)
Time Frame: Day 35
Main change from baseline of cornea and conjunctiva staining (Oxford scale from 0 to 15, 15 meaning a worse outcome) in the contralateral eye
Day 35
OSDI (questionnaire)
Time Frame: Day 35
Main change from baseline of Ocular Surface Disease Index (OSDI) score
Day 35
Schirmer test
Time Frame: Day 35
Main change from baseline of Schirmer test result in the worse eye and contralateral eye
Day 35
Tear-Film Break Up Time (TBUT)
Time Frame: Day 35
Main change from baseline of Tear-Film Break Up Time (TBUT) in the worse eye and contralateral eye
Day 35
Conjunctival hyperaemia
Time Frame: Day 35
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
Day 35
Global performance by the investigator
Time Frame: Day 35
Global performance assessment by the investigator using a 4-point scale (Unsatisfactory, Not very satisfactory, Satisfactory, Very satisfactory)
Day 35
Global performance by the patient
Time Frame: Day 35
Global performance assessment by the patient using a 4-point scale (Unsatisfactory, Not very satisfactory, Satisfactory, Very satisfactory)
Day 35
Comfort upon device administration
Time Frame: Day 4, Day 11, Day 18, Day 25, Day 32
Evaluation of the comfort upon device administration by the patient using a 5-points scale (from very uncomfortable to very comfortable)
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
Evaluation of patient satisfaction on 5 Visual Analogical Scales (VAS) from 0 to 100 and calculation of the total score
Day 0, Day 7, Day 14, Day 21, Day 28, Day 35

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Horus Pharma

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Eurofins Dermscan Pharmascan

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Ewa Paw, MD, Eurofins Dermscan Poland

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
September 26, 2024

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
January 9, 2025

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
January 9, 2025

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
September 9, 2024

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 18, 2024

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
September 23, 2024

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
March 25, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 11, 2025

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
February 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 23E2474

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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Dry Eye

Clinical Trials on DM-28

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Cookie Settings

We use cookies to ensure that we give you the best experience on our website. For more details carefully read our Privacy and Cookies Policy. ...>>>You can change your preferences or withdraw your consent at any time by deleting the cookies from your website or computer as described in the policy. Please accept it and choose your preferences by ticking the corresponding boxes in the "Manage Settings" section below. Please carefully read our Terms of Service before you proceed with using any part of this website.
«Manage Settings