Phase
Condition
N/ATreatment
DM934
Théalose
Clinical Study ID
Ages > 18 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
Subject with a moderate to severe dry eye syndrome needing artificial tears in the 3months 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 duringwash-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:
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 thepresent CIP, at the Investigator's appreciation.
For applicable countries: subject being affiliated to a health social securitysystem.
Female subjects of childbearing potential should use a medically acceptedcontraceptive regimen since at least 12 weeks before the beginning of thestudy, during all the study and at least 1 month after the study end.
Exclusion
Exclusion Criteria:
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
Corneal neovascularization
Subject with severe meibomian gland dysfunction (MGD).
History of ocular trauma, infection or inflammation, not related to dry eye syndromewithin 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 withinthe 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 ophthalmicmedication, except tear substitutes, within 2 weeks prior to study start or expectedto receive ocular therapy during the study.
Any not stabilised systemic treatment, which can have an effect on performance orsafety 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.
Study Design
Connect with a study center
Eurofins Dermscan
Aix-en-Provence,
FranceSite Not Available
Eurofins EVIC
Bordeaux,
FranceSite Not Available
Eurofins Dermscan Poland
Gdańsk,
PolandSite Not Available
IOBA
Valladolid,
SpainSite Not Available
Ocular Technology Group
London,
United KingdomSite Not Available
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