This study is a multicentric, comparative, randomized, investigator-blinded, parallel group study to demonstrate the non-inferiority of DM934 in comparison with Théalose in terms of cornea and conjunctiva staining (Oxford score) on patients with moderate to severe ocular dryness, after 35 days of treatment
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
85
Eurofins Dermscan
Aix-en-Provence, France
Eurofins EVIC
Bordeaux, France
Eurofins Dermscan Poland
Gdansk, Poland
IOBA
Valladolid, Spain
Ocular Technology Group
London, United Kingdom
Cornea and conjunctiva staining (Oxford score)
Evaluation of the non-inferiority of DM934 in comparison with Théalose, in terms of cornea and conjunctiva staining (Oxford score), on worse eye
Time frame: 35 days
Cornea and conjunctiva staining (Oxford score) (performance)
Main change from baseline of cornea and conjunctiva staining (Oxford score) in the worse eye and contralateral eye
Time frame: 35 days
Cornea and conjunctiva staining (Oxford score) (performance)
Main change from baseline of cornea and conjunctiva staining (Oxford score) in the worse eye and contralateral eye
Time frame: 84 days
Tear-Film Break Up Time (TBUT) (performance)
Main change from baseline of Tear-Film Break Up Time (TBUT) in the worse eye and contralateral eye
Time frame: 35 days
Tear-Film Break Up Time (TBUT) (performance)
Main change from baseline of Tear-Film Break Up Time (TBUT) in the worse eye and contralateral eye
Time frame: 84 days
OSDI (questionnaire)(performance)
Main change from baseline of Ocular Surface Disease Index (OSDI) score
Time frame: 35 days
OSDI (questionnaire)(performance)
Main change from baseline of Ocular Surface Disease Index (OSDI) score
Time frame: 84 days
Van Bijsterveld score (performance)
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Main change from baseline of Van Bijsterveld score (lissamine green staining) in the worse eye and contralateral eye
Time frame: 35 days
Van Bijsterveld score (performance)
Main change from baseline of Van Bijsterveld score (lissamine green staining) in the worse eye and contralateral eye
Time frame: 84 days
Schirmer test (performance)
Main change from baseline of Schirmer test result in the worse eye and contralateral eye
Time frame: 35 days
Schirmer test (performance)
Main change from baseline of Schirmer test result in the worse eye and contralateral eye
Time frame: 84 days
Dry eye symptoms (performance)
Mean change from Baseline in the global sum score of dry eye symptoms at D84 : discomfort,burning, stinging,eye dryness sensation, itching,foreign body sensation,photophobia, blurred vision.Each graded from 0 to 10
Time frame: 35 days
Dry eye symptoms (performance)
Mean change from Baseline in the global sum score of dry eye symptoms at D84 : discomfort,burning, stinging,eye dryness sensation, itching,foreign body sensation,photophobia, blurred vision.Each graded from 0 to 10
Time frame: 84 days
Global performance by the investigator (performance)
Global performance assessment by the investigator using a 4-point scale (Unsatisfactory, Not very satisfactory, Satisfactory, Very satisfactory)
Time frame: 35 days
Global performance by the investigator (performance)
Global performance assessment by the investigator using a 4-point scale (Unsatisfactory, Not very satisfactory, Satisfactory, Very satisfactory)
Time frame: 84 days
Global performance by the patient (performance)
Global performance assessment by the patient using a 4-point scale (Unsatisfactory, Not very satisfactory, Satisfactory, Very satisfactory)
Time frame: 35 days
Global performance by the patient (performance)
lobal performance assessment by the patient using a 4-point scale (Unsatisfactory, Not very satisfactory, Satisfactory, Very satisfactory)
Time frame: 84 days
Number of Adverse Events (safety)
Collection of ocular and systemic adverse events
Time frame: 84 days