Clinical trial NCT03645850: Evaluation of Efficacy and Safety of Vismed Gel Multi 0.3% Versus Vismed Multi 0.18% on Treatment of Ocular Dryness
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
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Dry Eye
Lead sponsor: Horus Pharma
Sponsor class: INDUSTRY
First posted: 2018-08-24
Enrollment: 80
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Parallel Assignment Because the comparator will be in commercial packaging, the blinding of the subject is not possible.

However, the study will be blinded for the investigator: evaluations will be done by an independent investigator, different than the person who will distribute the product. Subjects will be identified by a patient number. Each patient number will be associated to a treatment number, according to a randomization list provided before the beginning of the clinical investigation, and randomized either in one of both treatment groups (Vismed Gel Multi 3% or Vismed Multi 0.18%).
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: 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.
timeFrame: 35 days
measure: To assess the total ocular surface fluorescein staining score at D84
timeFrame: 0 and 84 days
measure: Evolution of DEQ-5 score
timeFrame: 35 days
measure: Evolution of DEQ-5 score
timeFrame: 84 days
measure: Evolution of Van Bijterveld score ( lissamine green staining)
timeFrame: 35 Days
measure: Evolution of Van Bijterveld score ( lissamine green staining)
timeFrame: 84 days
measure: Volume tear fluid secretion as assessed by schirmer test
timeFrame: 35 days
measure: Volume tear fluid secretion as assessed by schirmer test
timeFrame: 84 days
measure: Evolution of Tear film Break-Up Time
timeFrame: 35 days
measure: Evolution of Tear film Break-Up Time
timeFrame: 84 days
measure: Global sum score of dry eye symptoms at visit 3 - mean change from Baseline at visit 3 ( D35)
timeFrame: 35 days
measure: Global sum score of dry eye symptoms at visit 4 - mean change from Baseline at visit 3 ( D84)
timeFrame: 84 days
measure: Global treatment performance score assessed by the investigator at visit 3
timeFrame: 35 days
measure: Global treatment performance score assessed by the investigator at visit 4
timeFrame: 84 days
measure: Global treatment performance score assessed by the patient at visit 3
timeFrame: 35 days
measure: Global treatment performance score assessed by the patient at visit 4
timeFrame: 84 days
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Hôpital Morvan, Brest, France
name: Béatrice Cochener-Lamard, Prof
role: PRINCIPAL_INVESTIGATOR
References: