Dry Eye Clinical Trial
Official title:
Evaluation of the Efficacy and Safety of Vismed® Gel Multi 0.3% Versus Vismed® Multi 0.18% on the Treatment of Moderate to Severe Ocular Dryness
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.
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