Efficacy and Safety of BUFY01 Versus SVS20 in the Treatment of Dry Eye Disease
NCT ID: NCT05865379
Last Updated: 2025-12-16
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
80 participants
INTERVENTIONAL
2026-01-31
2027-10-31
Brief Summary
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* 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.
Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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BUFY01
0.18% Sodium Hyaluronate (trometamol buffer) in single-dose containers of 0.3 mL
BUFY01 eye drops in single-dose containers
1 to 2 drops in each eye, as often as needed
SVS20
0.18% Sodium Hyaluronate (phosphate buffer) in single-dose containers of 0.3 mL
SVS20 eye drops in single-dose containers
1 to 2 drops in each eye, as often as needed
Interventions
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BUFY01 eye drops in single-dose containers
1 to 2 drops in each eye, as often as needed
SVS20 eye drops in single-dose containers
1 to 2 drops in each eye, as often as needed
Eligibility Criteria
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Inclusion Criteria
* 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
* 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.
18 Years
ALL
No
Sponsors
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TRB Chemedica International SA
INDUSTRY
Responsible Party
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Locations
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Hôpital des Quinze-Vingts
Paris, , France
CHU Saint-Etienne
Saint-Priest-en-Jarez, , France
Countries
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Facility Contacts
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Other Identifiers
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BUFY01-CT-2101
Identifier Type: -
Identifier Source: org_study_id