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

Horus Pharma

Status: Unknown

Conditions: Dry Eye

Treatments: Device: Vismed Multi 0.18% eye drops; Device: Vismed gel Multi 0.3% eye drops

Study type: Interventional

Funder types: Industry

Identifiers

NCT03645850

2018-A01711-54 (Other Identifier)

17E4554

Details and patient eligibility

About

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 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.

Enrollment: 80 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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80 participants in 2 patient groups

Investig. device:Vismed Gel Multi 0.3%

Experimental group

Description:

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

Treatment:

Device: Vismed gel Multi 0.3% eye drops

Comparative device: Vismed Multi 0.18%

Active Comparator group

Description:

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

Treatment:

Device: Vismed Multi 0.18% eye drops