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

Launched by TRB CHEMEDICA INTERNATIONAL SA · May 9, 2023

Keywords

ClinConnect Summary

This clinical trial is studying two treatments, BUFY02 and TRB02, for people suffering from dry eye disease. The main goal is to find out if BUFY02 works just as well as TRB02 in relieving both the symptoms and signs of this condition. Participants will need to visit the trial site four times over three months, use the assigned treatment daily, complete some questionnaires, and return any unused treatment.

To be eligible for this study, participants should have a history of dry eye disease that has required the use of artificial tears for at least three months, and one of their eyes must show specific signs of tear deficiency. People with certain eye conditions, recent contact lens use, or those who have had certain eye surgeries may not be able to participate. This trial is currently not recruiting, but it aims to compare the safety and effectiveness of both treatments for everyone's benefit.

Gender

ALL

Eligibility criteria

• 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.