Evaluation Of A Novel Preservative-Free Formulation Of Brimonidine Tartrate Ophthalmic Solution For The Treatment Of Conjunctival Hyperaemia
Published 2025 - 43rd Congress of the ESCRS
Reference: PP20.18 | Type: Poster | DOI: 10.82333/tkkt-x247
Authors: Miltos Balidis* 1 , Melissa Toyos 2 , Melinda DiVito 3 , Elisabeth Messmer 4 , Selina McGee 5 , Jared Peterson 6 , Assem Patel 7 , Guruprasad Pattar 8 , David Evans 9 , Patrick Vollmer 7 , Gina Wesley 10
1Democretian University of Thrace,Komotini,Greece;Aristotle University of Thessaloniki,Thessaloniki,Greece, 2Toyos Clinic,Memphis,United States, 3Bausch + Long,Bridgewater,United States, 4Ophthalmology ,Ludwig-Maximilian University,Munich,Germany, 5BeSpoke Vision,Oklahoma,United States, 6Mountain View Eye Center,Layton,United States, 7Vita Eye Clinic,Shelby ,United States, 8The Eye Care Institute,Louisville,United States, 9Total Eye Care,Menphis,United States, 10Complete Eye Care of Medina,Hamel,United States
Purpose
Conjunctival hyperaemia (CH) is a common sign of acute anterior inflammation, which can occur following ocular surgery and cause patient distress. Low-dose (0.25 mg/ml) brimonidine tartrate ophthalmic solution (BTOS) is approved for the treatment of conjunctival hyperaemia. BTOS contains benzalkonium chloride (BAK), the most used preservative in ophthalmic pharmaceuticals. As frequent exposure of the ocular surface to BAK can induce or exacerbate existing ocular irritation – a particular concern following surgery – a preservative-free formulation of BTOS (BTOS-PF) has been developed.
Setting
This was a multicentre, double-masked, randomized, active-controlled, parallel-group study in healthy adults (>18 years) with ocular redness, conducted at 6 study sites in the United States of America. As the safety outcomes of the study were reported at the ESCRS Congress 2024, this analysis focusses on the efficacy outcomes of the study.
Methods
The study occurred over 5 weeks out to Visit 4 (Day 36 + 1 day). Participants were randomised 1:1 to receive either BTOS or BTOS-PF. After the initial in‑office dose at Visit 1, both groups self-administered a single drop of study agent 4 times daily, approximately 4 hours apart, for a duration of 4 weeks. The primary efficacy endpoint was ocular redness score as evaluated by the investigator prior to and at 5 (+1), 15 (+1), 30 (+1), 60 (+10), 90 (+10), 120 (+15), 180 (+15), and 240 (+15) minutes after investigational drug instillation (0–4-unit scale, allowing half-unit increments) at Visit 1.
Results
380 participants were randomized 1:1 to receive BTOS-PF or BTOS and formed the ITT population. Compliance was high across all participants (95.7%). Mean (standard deviation) treatment exposure was similar for both treatment arms: 28.0 (6.83) days for the BTOS-PF group and 29.0 (4.17) days for the BTOS group. Baseline (pre-instillation) ocular redness values were comparable between the BTOS-PF and BTOS groups. All post-instillation redness values observed at all timepoints were also comparable between treatment arms, with mean differences between treatment groups ranging from -0.09 to 0.01 units, with upper confidence limits at all timepoints falling within the pre-determined limit for non-inferiority of 0.22 units.
Conclusions
The primary endpoint was met with the novel BTOS-PF demonstrating statistical non-inferiority to BTOS in the reduction of ocular redness at all timepoints from 5 minutes to 240 minutes post-instillation. Therefore, BTOS-PF provides comparable efficacy and (as previously reported) comparable safety to BTOS, offering patients a preservative-free formulation without compromise and reducing the potential for BAK-induced irritation.