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Kelly K Nichols, Parag A Majmudar, Eric D Donnenfeld, Aparna Raychadhuri, Charles P Semba; A One-year, Multicenter, Randomized, Double-masked Placebo-controlled Study of Lifitegrast Ophthalmic Solution 5.0% in Patients with Dry Eye: Findings for Subjects Electing to Use Artificial Tears. Invest. Ophthalmol. Vis. Sci. 2015;56(7 ):325.
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© ARVO (1962-2015); The Authors (2016-present)
To evaluate rate of elective artificial tear use and safety outcomes during a 1-year safety study of lifitegrast (LIF) ophthalmic solution 5.0% compared with placebo (PBO) in patients with dry eye disease (DED).
SONATA was a multicenter, randomized, prospective, double-masked, placebo-controlled Phase 3 safety study conducted in the US. Adult subjects (≥18 yrs) with DED (Schirmer test without anesthesia ≥1 and ≤10 mm, corneal staining score ≥2.0, visual analogue scale score ≥40 for either eye dryness or eye discomfort) were randomized 2:1 (LIF: PBO) to receive ophthalmic drops twice daily for 360 days. Safety population received ≥1 dose of study drug. Patients were allowed elective use of artificial tears after day 14. Use of artificial tears and TEAEs among subjects using artificial tears were evaluated. This was a safety study; no hypothesis testing was done to compare the outcomes in the 2 treatment groups.
The safety population comprised 331 subjects (220 LIF; 111 PBO). Among those with available data, 64/195 (32.8%) in LIF group and 43/98 (43.9%) in PBO group used artificial tears during the study. Artificial tear use at specific time points is shown in Figure. Subjects who used artificial tears had higher rates of ocular TEAEs (43/64 [67.2%], LIF group; 19/43 [44.2%], PBO group) than those not using artificial tears (61/134 [45.5%], LIF; 14/55 [25.5%], PBO). Rates of non-ocular TEAEs were also higher among those using artificial tears (39/64 [60.9%], LIF; 19/43 [44.2%], PBO) versus those who did not (58/134 [43.3%], LIF; 18/55 [32.7%], PBO). Fewer subjects who used artificial tears withdrew prematurely from the study (2/64 [3.1%], LIF; 0/43, PBO) versus those not using artificial tears (9/134 [6.7%], LIF; 3/55 [5.5%], PBO). Most TEAEs were mild to moderate. No clinically meaningful differences were observed between artificial tears subgroups with moderate-to-severe TEAEs. There were no serious ocular TEAEs.
Subjects receiving LIF in this 1-year study used artificial tears less frequently than those receiving PBO. Rates of TEAEs were highest among those using both LIF and artificial tears. Subjects electing to use artificial tears were less likely to prematurely withdraw.
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