NCT05865457

Brief Summary

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.

Trial Health

80
On Track

Trial Health Score

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

Enrollment
80

participants targeted

Target at P50-P75 for not_applicable

Timeline
12mo left

Started Sep 2025

Geographic Reach
2 countries

5 active sites

Status
recruiting

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress37%
Sep 2025Jun 2027

First Submitted

Initial submission to the registry

May 9, 2023

Completed
9 days until next milestone

First Posted

Study publicly available on registry

May 18, 2023

Completed
2.4 years until next milestone

Study Start

First participant enrolled

September 25, 2025

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2027

Expected
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2027

Last Updated

February 5, 2026

Status Verified

February 1, 2026

Enrollment Period

1.4 years

First QC Date

May 9, 2023

Last Update Submit

February 2, 2026

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)

BUFY02

EXPERIMENTAL

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

Device: BUFY02 eye drops in single-dose containers

TRB02

ACTIVE COMPARATOR

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

Device: TRB02 eye drops in single-dose containers

Interventions

BUFY02 eye drops in single-dose containersDEVICE

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

BUFY02
TRB02 eye drops in single-dose containersDEVICE

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

TRB02

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (5)

Medical University Graz

Graz, Austria

RECRUITING

VIROS

Vienna, Austria

RECRUITING

CHRU Brest

Brest, France

RECRUITING

Hôpital Bicêtre

Le Kremlin-Bicêtre, France

RECRUITING

CHU Nice

Nice, France

RECRUITING

MeSH Terms

Conditions

Dry Eye Syndromes

Condition Hierarchy (Ancestors)

Lacrimal Apparatus DiseasesEye 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 9, 2023

First Posted

May 18, 2023

Study Start

September 25, 2025

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

AU(2)FR(3)