BUSTON-02: Efficacy and Safety of BUFY02 Versus TRB02 in the Treatment of Dry Eye Disease

• Sponsor: TRB Chemedica International SA (Industry)
• Overall Status: Not yet recruiting
• CT.gov ID: NCT05865457
• Collaborator: (none)
• Enrollment: 80
• Arms: 2
• Anticipated Duration (Months): 12

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Dry Eye Disease	Device: BUFY02 eye drops in single-dose containers; Device: TRB02 eye drops in single-dose containers	N/A

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 80 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
• Primary Purpose: Treatment
• Official Title: Efficacy and Safety of BUFY02 Versus TRB02 in the Treatment of Dry Eye Disease: a Non-inferiority Investigation
• Anticipated Study Start Date: Oct 1, 2023
• Anticipated Primary Completion Date: Aug 1, 2024
• Anticipated Study Completion Date: Oct 1, 2024

Arms and Interventions

Arm	Intervention/Treatment
Experimental: BUFY02 0.3% Sodium Hyaluronate (trometamol buffer) in single-dose containers of 0.45 mL	Device: BUFY02 eye drops in single-dose containers; 1 to 2 drops in each eye, as often as needed
Active Comparator: TRB02 0.3% Sodium Hyaluronate (phosphate buffer) in single-dose containers of 0.45 mL	Device: TRB02 eye drops in single-dose containers; 1 to 2 drops in each eye, as often as needed

Outcome Measures

Primary Outcome Measures

1. Signs [Day 28]

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

Secondary Outcome Measures

1. Symptoms [Day 28]

   Change from baseline in Ocular Surface Disease Index

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria include:

• 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 include:

• 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.

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

• TRB Chemedica International SA

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: TRB Chemedica International SA
• ClinicalTrials.gov Identifier: NCT05865457
• Other Study ID Numbers: BUFY02-CT-2201
• First Posted: May 18, 2023
• Last Update Posted: May 24, 2023
• Last Verified: May 1, 2023

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Dry Eye Syndromes; Keratoconjunctivitis Sicca; Eye Diseases; Ophthalmic Solutions

Study Results

No Results Posted as of May 24, 2023