Abstract
Purpose :
Low-dose (0.025%) brimonidine tartrate ophthalmic solution was approved by the FDA in 2017 under the brand name LUMIFY®. For some, frequent exposure of the ocular surface to the preservative benzalkonium chloride can induce or exacerbate existing ocular irritation. Thus, a preservative-free formulation of brimonidine tartrate ophthalmic solution 0.025% (BTOS-PF) has been developed. Here we describe results from a study evaluating the efficacy and safety of BTOS-PF vs LUMIFY.
Methods :
This was a multi-center, double-masked, randomized, active-controlled, parallel-group study in healthy adults (> 18 years of age) with ocular redness, conducted at 6 sites in the US. The study occurred over 5 weeks: Screening Visit (Day -28 to Day 1); Visit 1 (Baseline; Day 1); Visit 2 (Day 15 ± 2 days); Visit 3 (Day 29 + 2 days); and Visit 4 (Day 36 + 1 day). After the initial in-office dose at Visit 1, both agents were self-administered 4 times daily ~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 LUMIFY and formed the ITT population. Baseline (pre-instillation) ocular redness values were comparable between the BTOS-PF and LUMIFY 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 preservative-free formulation of brimonidine tartrate ophthalmic solution demonstrating statistical non-inferior to LUMIFY in the reduction of ocular redness at all timepoints from five minutes to 240 minutes post-instillation.
This abstract was presented at the 2024 ARVO Annual Meeting, held in Seattle, WA, May 5-9, 2024.