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

NCT ID: NCT03645850

Last Updated: 2018-08-24

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 80 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-09-01
• Study Completion Date: 2019-06-15

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.

Conditions

Dry Eye

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Investig. device:Vismed Gel Multi 0.3%

Vismed gel Multi 0.3% eye drops: 1 to 2 drops in each eye between 4 and 6 times per day during 84 days

Group Type: EXPERIMENTAL

Vismed gel Multi 0.3% eye drops

Intervention Type: DEVICE

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.

Comparative device: Vismed Multi 0.18%

Vismed Multi 0.18% eye drops: 1 to 2 drops in each eye between 4 and 6 times per day during 84 days

Group Type: ACTIVE_COMPARATOR

Vismed Multi 0.18% eye drops

Intervention Type: DEVICE

Ophthalmic use. One to two drops instilled in each eye from 4 to 6 times per day during 84 days of treatment.

Interventions

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.

Intervention Type: 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.

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

• Sex: male or female.
• Age: more than 18 years.
• Subject with a moderate to severe dry eye syndrome needing artificial tears in the 3 months preceding the inclusion.
• Subject having used only artificial tears without preservative (NaCl 0.9%, Hydrabak®) during 1 to 2 weeks before inclusion (up to 6 times a day).
• Subject with a score ≥ 6 for the 5-Item Dry Eye Questionnaire (DEQ-5)
• Subject with at least one eye with:

• Global ocular staining (cornea and conjunctiva) ≥4 and ≤9 on the Oxford scale (0 to 15)

AND one of the following criteria:

• Schirmer test ≥ 3 mm/5 min and ≤ 9 mm/5 min OR
• Sum of 3 measurements of Tear film Break-Up Time (TBUT) ≤ 30s.

• Subject, having given freely and expressly his/her informed consent.
• Subject who is able to comply with the study requirements, as defined in the present CIP, at the Investigator's appreciation.
• In France: subject being affiliated to a health social security system. Female subjects of childbearing potential should use a medically accepted contraceptive regimen since at least 12 weeks before the beginning of the study, during all the study and at least 1 month after the study end.

Exclusion Criteria

• Pregnant or nursing woman or planning a pregnancy during the study.
• Subject deprived of freedom by administrative or legal decision.
• Subject in a social or health institution
• Subject who is under guardianship or who is not able to express his/her consent.
• Subject being in an exclusion period for a previous study.
• Subject suspected to be non-compliant according to the Investigator's judgment.
• Subject wearing contact lenses during the study.
• Far best corrected visual acuity < 1/10
• Subject with severe ocular dryness with one of these conditions:

• Eyelid or blinking malfunction
• Corneal disorders not related to dry eye syndrome
• Ocular metaplasia
• Filamentous keratitis
• Corneal neovascularization
• Subject with severe meibomian gland dysfunction (MGD)
• History of ocular trauma, infection or inflammation, not related to dry eye syndrome within the last 3 months prior to the inclusion.
• History of ocular allergy or ocular herpes within the last 12 months.
• Subjects who underwent ocular surgery, including laser surgery, in either eye within the last 6 months.
• Any troubles of the ocular surface not related to dry eye syndrome.
• Subject having used artificial tears in the 6 hours preceding the inclusion visit.
• Use of the following ocular treatments: isotretinoïd, cyclosporine, tacrolimus, sirolimus, pimecrolimus, punctual plugs during the month preceding the inclusion.
• Subjects who have received ocular therapy (either eye) with any ophthalmic medication, except tear substitutes, within 2 weeks prior to study start or expected to receive ocular therapy during the study.
• Any not stabilised systemic treatment, which can have an effect on performance or safety criteria, at the investigator appreciation.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Horus Pharma

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Béatrice Cochener-Lamard, Prof

Role: PRINCIPAL_INVESTIGATOR

Hôpital Morvan, Brest, France

Central Contacts

Aurore Garnier

Role: CONTACT

aurore.garnier@horus-pharma.fr

0033483322078

Other Identifiers

2018-A01711-54

Identifier Type: OTHER

Identifier Source: secondary_id

17E4554

Identifier Type: -

Identifier Source: org_study_id