This study is a multicentric, comparative, randomized, investigator-blinded, parallel group study to demonstrate the non-inferiority of Vismed® Gel Multi 0.3% in comparison with Vismed® Multi 0.18% in terms of cornea and conjunctiva staining (Oxford score) on patients with moderate to severe ocular dryness, after 35 days of treatment.
Evaluation of the non-inferiority of Vismed® Gel Multi 0.3% in comparison with Vismed® Multi 0.18%, in terms of cornea and conjunctiva staining (Oxford score), on worse eye, between Day 0 and Day 35. Evaluation of the non-inferiority of Vismed® Gel Multi 0.3% in comparison with Vismed® Multi 0.18%, in terms of cornea and conjunctiva staining (Oxford score), on worse eye, between Day 0 and Day 35. * Comparison of Day 35 versus Day 0 and Day 84 versus Day 0 for each product and comparison between products for the following parameters: * Evolution of cornea and conjunctiva staining (Oxford score) on worse eye. * Evolution of DEQ-5 score (5-items Dry Eye Questionnaire). * Evolution of Van Bijsterveld score (Lissamine green staining) in worse eye. * Evolution of Schirmer test result in worse eye. * Evolution of Tear film Break-Up Time (TBUT) in worse eye. * Evolution of ocular dryness severity by evaluation of each main symptom by the patient and total score of all symptoms * Evaluation of treatment performance by the investigator and the patient. * Evaluation of the average frequency of use over 84 days for both products.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
80
Ophthalmic use. Vismed gel Multi 0.3% eye drops. One to two drops instilled in each eye from 4 to 6 times per day during 84 days of treatment.
Ophthalmic use. One to two drops instilled in each eye from 4 to 6 times per day during 84 days of treatment.
Demonstrate the non-inferiority of Vismed® Gel Multi 0.3% in comparison with Vismed® Multi 0.18% in terms of cornea and conjunctiva staining (Oxford score) on patients with moderate to severe ocular dryness, after 35 days of treatment.
Assess the ocular surface fluorescein staining score- mean change from Baseline in the study at D35 in ocular surface fluorescein stainig score according to a scale from zero to 15
Time frame: 35 days
To assess the total ocular surface fluorescein staining score at D84
Mean change from Baseline (D0) in the study eye and D84 in the total ocular surface fluoresceine staining score
Time frame: 0 and 84 days
Evolution of DEQ-5 score
Evolution from Baseline of DEQ-5 questionnaire scores at day 35
Time frame: 35 days
Evolution of DEQ-5 score
Evolution from Baseline of DEQ-5 questionnaire scores at day 84
Time frame: 84 days
Evolution of Van Bijterveld score ( lissamine green staining)
Mean change from Baseline ( D0) and D 35 in the total Van Bijterveld score
Time frame: 35 Days
Evolution of Van Bijterveld score ( lissamine green staining)
Mean change from Baseline ( D0) and D 84 in the total Van Bijterveld score
Time frame: 84 days
Volume tear fluid secretion as assessed by schirmer test
Mean change from Baseline ( D0) in Volume tear fluid secretion as assessed
Time frame: 35 days
Volume tear fluid secretion as assessed by schirmer test
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Mean change from Baseline ( D0) in Volume tear fluid secretion as assessed
Time frame: 84 days
Evolution of Tear film Break-Up Time
Mean change from Baseline (D0) in the study eye in TFBUT at Day 35
Time frame: 35 days
Evolution of Tear film Break-Up Time
Mean change from Baseline (D0) in the study eye in TFBUT at Day 84
Time frame: 84 days
Global sum score of dry eye symptoms at visit 3 - mean change from Baseline at visit 3 ( D35)
Mean change from Baseline in the global sum score of dry eye symptoms at D35 : discomfort,burning, stinging,eye dryness sensation, itching,foreign body sensation,photophobia, blurred vision.Each graded from 0 to 10
Time frame: 35 days
Global sum score of dry eye symptoms at visit 4 - mean change from Baseline at visit 3 ( D84)
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 treatment performance score assessed by the investigator at visit 3
Total Treatment performance score graded from 0 to 4
Time frame: 35 days
Global treatment performance score assessed by the investigator at visit 4
Total Treatment performance score graded from 0 to 4
Time frame: 84 days
Global treatment performance score assessed by the patient at visit 3
Total Treatment performance score graded from 0 to 4
Time frame: 35 days
Global treatment performance score assessed by the patient at visit 4
Total Treatment performance score graded from 0 to 4
Time frame: 84 days