NCT03645850

Evaluation of Efficacy and Safety of Vismed Gel Multi 0.3% Versus Vismed Multi 0.18% on Treatment of Ocular Dryness

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

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 80 (estimated)
• Sponsor: Horus Pharma · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

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.

Conditions

• Dry Eye

Interventions

Type	Name	Description
DEVICE	Vismed gel Multi 0.3% eye drops	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.
DEVICE	Vismed Multi 0.18% eye drops	Ophthalmic use. One to two drops instilled in each eye from 4 to 6 times per day during 84 days of treatment.

Timeline

• Start date: 2018-09-01
• Primary completion: 2019-03-01
• Completion: 2019-06-15
• First posted: 2018-08-24
• Last updated: 2018-08-24