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

Overview

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.

Full Title of Study: “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”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Treatment
    • Masking: Single (Investigator)
  • Study Primary Completion Date: March 1, 2019

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.

Interventions

  • 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.

Arms, Groups and Cohorts

  • Experimental: 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
  • Active Comparator: 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

Clinical Trial Outcome Measures

Primary Measures

  • 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.
    • Time Frame: 35 days
    • Assess the ocular surface fluorescein staining score- mean change from Baseline in the study at D35 in ocular surface fluorescein stainig score according to a scale from zero to 15
  • To assess the total ocular surface fluorescein staining score at D84
    • Time Frame: 0 and 84 days
    • Mean change from Baseline (D0) in the study eye and D84 in the total ocular surface fluoresceine staining score
  • Evolution of DEQ-5 score
    • Time Frame: 35 days
    • Evolution from Baseline of DEQ-5 questionnaire scores at day 35
  • Evolution of DEQ-5 score
    • Time Frame: 84 days
    • Evolution from Baseline of DEQ-5 questionnaire scores at day 84
  • Evolution of Van Bijterveld score ( lissamine green staining)
    • Time Frame: 35 Days
    • Mean change from Baseline ( D0) and D 35 in the total Van Bijterveld score
  • Evolution of Van Bijterveld score ( lissamine green staining)
    • Time Frame: 84 days
    • Mean change from Baseline ( D0) and D 84 in the total Van Bijterveld score
  • Volume tear fluid secretion as assessed by schirmer test
    • Time Frame: 35 days
    • Mean change from Baseline ( D0) in Volume tear fluid secretion as assessed
  • Volume tear fluid secretion as assessed by schirmer test
    • Time Frame: 84 days
    • Mean change from Baseline ( D0) in Volume tear fluid secretion as assessed
  • Evolution of Tear film Break-Up Time
    • Time Frame: 35 days
    • Mean change from Baseline (D0) in the study eye in TFBUT at Day 35
  • Evolution of Tear film Break-Up Time
    • Time Frame: 84 days
    • Mean change from Baseline (D0) in the study eye in TFBUT at Day 84
  • Global sum score of dry eye symptoms at visit 3 – mean change from Baseline at visit 3 ( D35)
    • Time Frame: 35 days
    • Mean change from Baseline in the global sum score of dry eye symptoms at D35 : discomfort,burning, stinging,eye dryness sensation, itching,foreign body sensation,photophobia, blurred vision.Each graded from 0 to 10
  • Global sum score of dry eye symptoms at visit 4 – mean change from Baseline at visit 3 ( D84)
    • Time Frame: 84 days
    • Mean change from Baseline in the global sum score of dry eye symptoms at D84 : discomfort,burning, stinging,eye dryness sensation, itching,foreign body sensation,photophobia, blurred vision.Each graded from 0 to 10
  • Global treatment performance score assessed by the investigator at visit 3
    • Time Frame: 35 days
    • Total Treatment performance score graded from 0 to 4
  • Global treatment performance score assessed by the investigator at visit 4
    • Time Frame: 84 days
    • Total Treatment performance score graded from 0 to 4
  • Global treatment performance score assessed by the patient at visit 3
    • Time Frame: 35 days
    • Total Treatment performance score graded from 0 to 4
  • Global treatment performance score assessed by the patient at visit 4
    • Time Frame: 84 days
    • Total Treatment performance score graded from 0 to 4

Participating in This Clinical Trial

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.

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Horus Pharma
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Official(s)
    • Béatrice Cochener-Lamard, Prof, Principal Investigator, Hôpital Morvan, Brest, France
  • Overall Contact(s)
    • Aurore Garnier, 0033483322078, aurore.garnier@horus-pharma.fr

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