NCT05191771

Brief Summary

This study is a multicentric, comparative, randomized, investigator-blinded, in parallel groups study to demonstrate the non-inferiority of Neovis® Total Multi in comparison with Systane® Balance, in terms of improvement of stability of Tear film in patients with eye dryness associated to meibomian gland dysfunction, after 28 days of treatment.

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
120

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jan 2022

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

December 10, 2021

Completed
22 days until next milestone

Study Start

First participant enrolled

January 1, 2022

Completed
12 days until next milestone

First Posted

Study publicly available on registry

January 13, 2022

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2022

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2022

Completed
Last Updated

January 13, 2022

Status Verified

January 1, 2022

Enrollment Period

9 months

First QC Date

December 10, 2021

Last Update Submit

January 3, 2022

Conditions

Dry EyeMeibomian Gland Dysfunction

Outcome Measures

Primary Outcomes (1)

  • Tear-Film Break Up Time (TBUT)

    Evaluation of the non-inferiority of Neovis® Total Multi in comparison with Systane® Balance, in terms of TBUT improvement, on worse eye

    28 days

Secondary Outcomes (28)

  • Tear-Film Break Up Time (TBUT) (performance)

    84 days

  • Cornea and conjunctiva staining (Oxford score) (performance)

    28 days

  • Cornea and conjunctiva staining (Oxford score) (performance)

    84 days

  • Meibomian gland expression (performance)

    28 days

  • Meibomian gland expression (performance)

    84 days

  • +23 more secondary outcomes

Other Outcomes (8)

  • Non-Invasive Tear film Break-Up Time (NIBUT) (exploratory, optional)

    28 days

  • Non-Invasive Tear film Break-Up Time (NIBUT) (exploratory, optional)

    84 days

  • Lipid layer thickness (exploratory, optional)

    28 days

  • +5 more other outcomes

Study Arms (2)

Investigational product

EXPERIMENTAL
Device: Neovis Total Multi

Comparator

ACTIVE COMPARATOR
Device: Systane Balance

Interventions

Neovis Total MultiDEVICE

1 drop in each eye, 4 times per day

Investigational product
Systane BalanceDEVICE

1 drop in each eye, 4 times per day

Comparator

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Presenting dry eye symptoms for at least 6 months.
  • OSDI (Ocular Surface Disease Index) ≥ 18
  • At least one eye eligible with:
  • sum of peripheral corneal and conjunctival staining ≥ 4 and ≤ 9 (Oxford 0-15 grading scheme) AND
  • sum of 3 measurements of Tear film Break-Up Time (TBUT) ≤ 15s
  • Meibomian Gland Dysfunction on at least one eye (same eye eligible) with a score of 1 or higher for meibum quality score (from 0: clear to 3: toothpaste/obstruction) and evidence of partial or whole missing Meibomian Glands.
  • Ability and willingness to apply eyelid hygiene during the whole study, including wash-out period.
  • Having given freely and expressly his/her informed consent.
  • 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.
  • Use of contact lenses in either eye 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
  • History of ocular traumatism, ocular infection or ocular inflammation within the last 3 months.
  • 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.
  • +13 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Dry Eye SyndromesMeibomian Gland Dysfunction

Condition Hierarchy (Ancestors)

Lacrimal Apparatus DiseasesEye DiseasesEyelid Diseases

Study Officials

  • Hoffart Louis

    Vision Sud

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Laure Chauchat

CONTACT

+33 (0)4 89 08 90 98laure.chauchat@horus-pharma.com

Study Design

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

Study Record Dates

First Submitted

December 10, 2021

First Posted

January 13, 2022

Study Start

January 1, 2022

Primary Completion

October 1, 2022

Study Completion

December 1, 2022

Last Updated

January 13, 2022

Record last verified: 2022-01