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Efficacy and Safety of BUFY01 Versus SVS20 in the Treatment of Dry Eye Disease (BUSTON-01)

Primary Purpose

Dry Eye Disease

Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
BUFY01 eye drops in single-dose containers
SVS20 eye drops in single-dose containers
Sponsored by
TRB Chemedica International SA
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Dry Eye Disease

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria includes: At least a 3-month documented history of bilateral dry eye syndrome needing artificial tears; At least one eye with Oxford score ≥ 4 and ≤ 9; At least one objective sign of tear deficiency (in at least one eligible eye); Having a health insurance. Exclusion Criteria includes: Wear of contact lenses starting within the last 2 months; Best-corrected visual acuity (BCVA) < 1/10; Severe DED with one of the listed conditions: Severe blepharitis; Seasonal allergy; Any issues of the ocular surface not related to DED; History of ocular trauma, infection or inflammation not related to DED; History of ocular surgery, including laser surgery; Unstable glaucoma; Use of artificial tears with preservative within the last 2 weeks; Systemic (enteral or parenteral) or local (topical) use of one of the listed medications: Known hypersensitivity to any constituent of the study treatments; Pregnancy or breastfeeding; Participation in another clinical study within the last 90 days; Legally restricted autonomy, freedom of decision and action.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Active Comparator

    Arm Label

    BUFY01

    SVS20

    Arm Description

    0.18% Sodium Hyaluronate (trometamol buffer) in single-dose containers of 0.3 mL

    0.18% Sodium Hyaluronate (phosphate buffer) in single-dose containers of 0.3 mL

    Outcomes

    Primary Outcome Measures

    Signs
    Change from baseline in Oxford score (0-15, a higher score meaning a worse outcome)

    Secondary Outcome Measures

    Symptoms
    Change from baseline in Ocular Surface Disease Index

    Full Information

    First Posted
    May 1, 2023
    Last Updated
    May 22, 2023
    Sponsor
    TRB Chemedica International SA
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    1. Study Identification

    Unique Protocol Identification Number
    NCT05865379
    Brief Title
    Efficacy and Safety of BUFY01 Versus SVS20 in the Treatment of Dry Eye Disease
    Acronym
    BUSTON-01
    Official Title
    Efficacy and Safety of BUFY01 Versus SVS20 in the Treatment of Dry Eye Disease: a Non-inferiority Investigation
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    May 2023
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    October 2023 (Anticipated)
    Primary Completion Date
    August 2024 (Anticipated)
    Study Completion Date
    October 2024 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    TRB Chemedica International SA

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    No

    5. Study Description

    Brief Summary
    The goal of this interventional investigation is to compare BUFY01 with SVS20 in the treatment of patients with dry eye disease. The main questions it aims to answer are: Is BUFY01 non-inferior to SVS20 in terms of signs of DED? Is BUFY01 non-inferior to SVS20 in terms of symptoms of DED? Participants will be asked to: Visit the trial site at 4 different timepoints Use the allocated study treatment everyday until the end of the study (during 3 months) Be examined by the investigator Complete several questionnaires Return unused study treatment. Researchers will compare BUFY01 to SVS20 to see if both study treatments provide similar effects on signs and symptoms of the disease, together with comparable safety.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Dry Eye Disease

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    ParticipantCare ProviderInvestigatorOutcomes Assessor
    Allocation
    Randomized
    Enrollment
    80 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    BUFY01
    Arm Type
    Experimental
    Arm Description
    0.18% Sodium Hyaluronate (trometamol buffer) in single-dose containers of 0.3 mL
    Arm Title
    SVS20
    Arm Type
    Active Comparator
    Arm Description
    0.18% Sodium Hyaluronate (phosphate buffer) in single-dose containers of 0.3 mL
    Intervention Type
    Device
    Intervention Name(s)
    BUFY01 eye drops in single-dose containers
    Intervention Description
    1 to 2 drops in each eye, as often as needed
    Intervention Type
    Device
    Intervention Name(s)
    SVS20 eye drops in single-dose containers
    Intervention Description
    1 to 2 drops in each eye, as often as needed
    Primary Outcome Measure Information:
    Title
    Signs
    Description
    Change from baseline in Oxford score (0-15, a higher score meaning a worse outcome)
    Time Frame
    Day 28
    Secondary Outcome Measure Information:
    Title
    Symptoms
    Description
    Change from baseline in Ocular Surface Disease Index
    Time Frame
    Day 28

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria includes: At least a 3-month documented history of bilateral dry eye syndrome needing artificial tears; At least one eye with Oxford score ≥ 4 and ≤ 9; At least one objective sign of tear deficiency (in at least one eligible eye); Having a health insurance. Exclusion Criteria includes: Wear of contact lenses starting within the last 2 months; Best-corrected visual acuity (BCVA) < 1/10; Severe DED with one of the listed conditions: Severe blepharitis; Seasonal allergy; Any issues of the ocular surface not related to DED; History of ocular trauma, infection or inflammation not related to DED; History of ocular surgery, including laser surgery; Unstable glaucoma; Use of artificial tears with preservative within the last 2 weeks; Systemic (enteral or parenteral) or local (topical) use of one of the listed medications: Known hypersensitivity to any constituent of the study treatments; Pregnancy or breastfeeding; Participation in another clinical study within the last 90 days; Legally restricted autonomy, freedom of decision and action.

    12. IPD Sharing Statement

    Plan to Share IPD
    No

    Learn more about this trial

    Efficacy and Safety of BUFY01 Versus SVS20 in the Treatment of Dry Eye Disease

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