Dry Eye
Conditions
Brief 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.
Interventions
DEVICEDM-28
1 drop in each eye, 4 to 6 times per day
Sponsors
Eurofins Dermscan Pharmascan
Horus Pharma
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Incidence of adverse device effects | 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) | 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Cornea and conjunctiva staining (Oxford scale) | 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 |
| OSDI (questionnaire) | Day 35 | Main change from baseline of Ocular Surface Disease Index (OSDI) score |
| Schirmer test | Day 35 | Main change from baseline of Schirmer test result in the worse eye and contralateral eye |
| Tear-Film Break Up Time (TBUT) | Day 35 | Main change from baseline of Tear-Film Break Up Time (TBUT) in the worse eye and contralateral eye |
| Far best corrected visual acuity (FBCVA) | Day 35 | Change from baseline of FBCVA |
| Global performance by the investigator | Day 35 | Global performance assessment by the investigator using a 4-point scale (Unsatisfactory, Not very satisfactory, Satisfactory, Very satisfactory) |
| Global performance by the patient | Day 35 | Global performance assessment by the patient using a 4-point scale (Unsatisfactory, Not very satisfactory, Satisfactory, Very satisfactory) |
| Comfort upon device administration | 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) |
| Patient satisfaction on device performance | 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 |
| Conjunctival hyperaemia | 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 |
| General safety | Day 35 | Collection and description of ocular and systemic Adverse Events |
Countries
Poland
Outcome results
None listed