BACKGROUND: Brimonidine tartrate ophthalmic solution 0.025% (Lumify®; BTOS) provides rapid ocular redness relief with very low risk of rebound redness or tachyphylaxis. Several marketed lubricant eye drops contain hyaluronic acid (HA). HA is a natural component in tears that helps to keep the eye moisturized and protects the eye from mechanical stress during blinking. A new BTOS formulation containing HA (BTOS-HA) has been developed.

METHOD: In this Phase 3, randomized, double-masked, active-controlled, parallel-group study at 11 US sites, adults with ocular redness (investigator-graded pre-instillation score >1 in both eyes on a 0–4 scale with half-unit increments) were randomized 1:1 to BTOS-HA or BTOS. Subjects received 1 drop in each eye 4 times daily for approximately 4 weeks. The primary endpoint was investigator-graded ocular redness on Day 1 at 5, 15, 30, 60, 90, 120, 180, and 240 minutes post-instillation. Noninferiority required the upper bound of the two-sided 95% confidence interval (BTOS-HA minus BTOS) to be ≤0.22 units at all 8 time points.

RESULTS: A total of 578 subjects were randomized to either BTOS-HA (N=289) or BTOS (N=289), with 575 receiving ≥1 dose. The mean (SD) pre-instillation redness score was 2.269 (0.5241) for BTOS-HA and 2.230 (0.5434) for BTOS. Post-instillation redness scores were low and similar between groups across all 8 time points on Day 1. Mean differences ranged from −0.007 to 0.025 units, with upper confidence limits ≤0.103, thereby meeting the primary endpoint of the study. Ocular and non-ocular treatment-emergent adverse event (TEAE) rates for BTOS-HA and BTOS were comparable. In the BTOS-HA group, instillation-site irritation (1.7%) was the only ocular TEAE reported in ≥1% of subjects. All ocular TEAEs in either group were mild or moderate. Serious TEAEs (BTOS-HA n=1; BTOS n=2) were non-ocular and unrelated to treatment.

CONCLUSION: BTOS-HA was noninferior to BTOS for Day 1 redness reduction through 4 hours and demonstrated a favorable safety and tolerability profile, offering a novel HA-containing formulation with comparable efficacy to BTOS.