MedDataX Logo

Efficacy and Safety of BUFY02 Versus TRB02 in the Treatment of Dry Eye Disease

NCT ID: NCT05865457

Last Updated: 2025-12-16

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

80 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-09-25

Study Completion Date

2027-06-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

The goal of this interventional investigation is to compare BUFY02 with TRB02 in the treatment of patients with dry eye disease. The main questions it aims to answer are:

* Is BUFY02 non-inferior to TRB02 in terms of signs of DED?
* Is BUFY02 non-inferior to TRB02 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 BUFY02 to TRB02 to see if both study treatments provide similar effects on signs and symptoms of the disease, together with comparable safety.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Dry Eye Disease

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

BUFY02

0.3% Sodium Hyaluronate (trometamol buffer) in single-dose containers of 0.45 mL

Group Type EXPERIMENTAL

BUFY02 eye drops in single-dose containers

Intervention Type DEVICE

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

TRB02

0.3% Sodium Hyaluronate (phosphate buffer) in single-dose containers of 0.45 mL

Group Type ACTIVE_COMPARATOR

TRB02 eye drops in single-dose containers

Intervention Type DEVICE

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

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

BUFY02 eye drops in single-dose containers

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

Intervention Type DEVICE

TRB02 eye drops in single-dose containers

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

Intervention Type DEVICE

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* 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

* 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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

TRB Chemedica International SA

INDUSTRY

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Medical University Graz

Graz, , Austria

Site Status RECRUITING

VIROS

Vienna, , Austria

Site Status RECRUITING

CHRU Brest

Brest, , France

Site Status RECRUITING

Hôpital Bicêtre

Le Kremlin-Bicêtre, , France

Site Status RECRUITING

CHU Nice

Nice, , France

Site Status RECRUITING

Countries

Review the countries where the study has at least one active or historical site.

Austria France

Facility Contacts

Find local site contact details for specific facilities participating in the trial.

Jutta Horwath-Winter, Dr

Role: primary

[email protected]
+43 316 385 80807

Stefan Palkovits, Dr

Role: primary

[email protected]
+43 1 91 021 57573

Beatrice Cochener, Prof.

Role: primary

[email protected]
+33 2 98 22 34 40

Marc Labetoulle

Role: primary

[email protected]
+33 1 45 21 36 90

Stéphanie Baillif, Prof.

Role: primary

[email protected]
+33 4 92 03 8025

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

BUFY02-CT-2201

Identifier Type: -

Identifier Source: org_study_id