Dry Eye Clinical Trial
Official title:
Evaluation of the Efficacy and Safety of DM05 Versus Optive™ on the Treatment of Moderate to Severe Ocular Dryness
This study is a multicentric, comparative, randomized, investigator-blinded, in parallel groups study to demonstrate the non-inferiority of DM05 in comparison with Optive™, 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 DM05 in comparison with OptiveTM, in terms of cornea and
conjunctiva staining (Oxford score), on worse eye, between D0 and D35.
- Comparison of D35 versus D0 and D84 versus D0 for each product and comparison between
products for the following parameters:
- Evolution of cornea and conjunctiva staining (Oxford score) on worse eye.
- Evolution of OSDI score (Ocular Surface Disease Index).
- 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 during 84 days for DM05 and OptiveTM.
Selection visit: D-14 to D-7
Wash-out period: 1 to 2 weeks with preservative-free 0.9% NaCl at 3 drops per day
(Hydrabak®):
D0 : inclusion visit Follow-up visits: D35, D84
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