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

NCT05865379 | Recruiting

• 1 other identifier: BUFY01-CT-2101
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 2

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.

Conditions

Dry Eye Disease

Outcome Measures

Primary Outcomes (1)

• Signs

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

  Day 28

Secondary Outcomes (1)

• Symptoms

  Day 28

Study Arms (2)

BUFY01

EXPERIMENTAL

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

Device: BUFY01 eye drops in single-dose containers

SVS20

ACTIVE COMPARATOR

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

Device: SVS20 eye drops in single-dose containers

Interventions

BUFY01 eye drops in single-dose containers DEVICE

1 to 2 drops in each eye, as often as needed

BUFY01

SVS20 eye drops in single-dose containers DEVICE

1 to 2 drops in each eye, as often as needed

SVS20

Eligibility Criteria

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

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• TRB Chemedica International SA: lead

Study Sites (2)

Hôpital des Quinze-Vingts

Paris, France

RECRUITING

CHU Saint-Etienne

Saint-Priest-en-Jarez, France

RECRUITING

MeSH Terms

Conditions

Dry Eye Syndromes

Condition Hierarchy (Ancestors)

Lacrimal Apparatus Diseases; Eye Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 1, 2023
• First Posted: May 18, 2023
• Study Start: March 1, 2026
• Primary Completion (Estimated): March 1, 2027
• Study Completion (Estimated): June 1, 2027
• Last Updated: February 5, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share

Locations

FR (2)