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

NCT03645850 | Unknown DMC

• 2 other identifiers: 17E45542018-A01711-54
• Study Type: interventional
• Target: 80
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Dry Eye

Outcome Measures

Primary Outcomes (16)

• 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.

  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

  35 days

• To assess the total ocular surface fluorescein staining score at D84

  Mean change from Baseline (D0) in the study eye and D84 in the total ocular surface fluoresceine staining score

  0 and 84 days

• Evolution of DEQ-5 score

  Evolution from Baseline of DEQ-5 questionnaire scores at day 35

  35 days

• Evolution of DEQ-5 score

  Evolution from Baseline of DEQ-5 questionnaire scores at day 84

  84 days

• Evolution of Van Bijterveld score ( lissamine green staining)

  Mean change from Baseline ( D0) and D 35 in the total Van Bijterveld score

  35 Days

• Evolution of Van Bijterveld score ( lissamine green staining)

  Mean change from Baseline ( D0) and D 84 in the total Van Bijterveld score

  84 days

• Volume tear fluid secretion as assessed by schirmer test

  Mean change from Baseline ( D0) in Volume tear fluid secretion as assessed

  35 days

• Volume tear fluid secretion as assessed by schirmer test

  Mean change from Baseline ( D0) in Volume tear fluid secretion as assessed

  84 days

• Evolution of Tear film Break-Up Time

  Mean change from Baseline (D0) in the study eye in TFBUT at Day 35

  35 days

• Evolution of Tear film Break-Up Time

  Mean change from Baseline (D0) in the study eye in TFBUT at Day 84

  84 days

• Global sum score of dry eye symptoms at visit 3 - mean change from Baseline at visit 3 ( D35)

  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

  35 days

• Global sum score of dry eye symptoms at visit 4 - mean change from Baseline at visit 3 ( D84)

  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

  84 days

• Global treatment performance score assessed by the investigator at visit 3

  Total Treatment performance score graded from 0 to 4

  35 days

• Global treatment performance score assessed by the investigator at visit 4

  Total Treatment performance score graded from 0 to 4

  84 days

• Global treatment performance score assessed by the patient at visit 3

  Total Treatment performance score graded from 0 to 4

  35 days

• Global treatment performance score assessed by the patient at visit 4

  Total Treatment performance score graded from 0 to 4

  84 days

Study Arms (2)

Investig. device:Vismed Gel Multi 0.3%

EXPERIMENTAL

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

Device: Vismed gel Multi 0.3% eye drops

Comparative device: Vismed Multi 0.18%

ACTIVE COMPARATOR

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

Device: Vismed Multi 0.18% eye drops

Interventions

Vismed gel Multi 0.3% eye drops 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.

Investig. device:Vismed Gel Multi 0.3%

Vismed Multi 0.18% eye drops DEVICE

Ophthalmic use. 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%

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Sex: male or female.
• Age: more than 18 years.
• 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.

You may not qualify if:

• 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 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 allergy or ocular herpes within the last 12 months.

Sponsors & Collaborators

• Horus Pharma: lead

MeSH Terms

Conditions

Dry Eye Syndromes

Condition Hierarchy (Ancestors)

Lacrimal Apparatus Diseases; Eye Diseases

Study Officials

• Béatrice Cochener-Lamard, Prof

  Hôpital Morvan, Brest, France

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Aurore Garnier

CONTACT

0033483322078; aurore.garnier@horus-pharma.fr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: 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%).

Study Record Dates

• First Submitted: August 22, 2018
• First Posted: August 24, 2018
• Study Start: September 1, 2018
• Primary Completion: March 1, 2019
• Study Completion: June 15, 2019
• Last Updated: August 24, 2018

Record last verified: 2018-08