Ignite Creation Date:
2025-12-24 @ 5:18 PM
Ignite Modification Date:
2026-02-20 @ 1:39 PM
Study NCT ID:
NCT03645850
Status:
UNKNOWN
Last Update Posted:
2018-08-24
First Post:
2018-08-22
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Evaluation of Efficacy and Safety of Vismed Gel Multi 0.3% Versus Vismed Multi 0.18% on Treatment of Ocular Dryness
Sponsor:
Horus Pharma
Organization:
Study Overview
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
Status:
UNKNOWN
Status Verified Date:
2018-08
Last Known Status:
NOT_YET_RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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.
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 Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
Secondary ID Infos
| Secondary ID | Type | Domain | Link | View |
|---|---|---|---|---|
| 2018-A01711-54 | OTHER | ANSM | View |