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

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.

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