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

Launched by TRB CHEMEDICA INTERNATIONAL SA · May 9, 2023

Keywords

ClinConnect Summary

This clinical trial is looking at two treatments, BUFY01 and SVS20, to see which one works better for people with dry eye disease. The main goal is to find out if BUFY01 is just as good as SVS20 in helping reduce both the signs and symptoms of dry eyes. If you decide to participate, you'll need to visit the trial site four times over three months, use the assigned treatment daily, and complete some questionnaires about your eyes.

To be eligible, you should have had dry eye symptoms for at least three months and have certain signs of tear deficiency in your eyes. However, there are some criteria that would exclude you from participating, such as recent contact lens use or severe eye conditions unrelated to dry eyes. If you join the trial, you'll help researchers compare the two treatments and learn more about their safety and effectiveness.

Gender

ALL

Eligibility criteria

• Inclusion Criteria includes:
• • 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 includes:
• • 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.