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Study shows good comfort level after lifitegrast instillation
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Patients treated with lifitegrast ophthalmic solution 5.0% in the OPUS-3 study reported a low level of discomfort post-instillation, with rapid relief and consistent improvement of tolerance over time.
OPUS-3 was one of the phase 3 FDA trials that proved the safety and efficacy of Xiidra (lifitegrast ophthalmic solution, Shire), an LFA-1 antagonist, vs. placebo.
The study included 711 participants randomized to receive lifitegrast vs. placebo. Comfort was evaluated on a scale of 0 (very comfortable) to 10 (very uncomfortable) immediately after instillation of the drop, at 1, 2 and 3 minutes on day 0, 14, 42 and 84.
For all visits, the comfort score of subjects treated with lifitegrast was higher (less comfortable) than in the placebo group, but improved within 3 minutes of instillation. Consistent improvement was observed over time, with increasingly fewer patients reporting discomfort of more than 3 at subsequent instillations.
“Overall ocular tolerability and comfort upon instillation are important considerations for ocular drugs, as they could affect patient adherence,” author Kelly K. Nichols, OD, MPH, PhD, told Primary Care Optometry News. “In OPUS-3, lifitegrast was generally well-tolerated, with scores approaching placebo levels at this time point. These results suggest that ocular tolerability with lifitegrast is good, and patients should generally not expect significant discomfort,”
Site irritation and site reaction, mild to moderate in severity, were the most frequent symptoms and rarely led to treatment discontinuation.
The authors reported that, in their experience, there are always patients with dry eye disease that experience discomfort with all eye drops.
“Further studies to characterize this subset of patients would be useful from a clinical care and research perspective,” they wrote. “In particular, the assessment of neuropathic ocular pain may be an important area of consideration.” – by Michela Cimberle
Disclosure: Nichols has received research funding from Allergan, Bruder, Eleven Biotherapeutics, Kala, the National Institutes of Health, Shire PLC/SARcode, TearScience and Vistakon, and has been a consultant for Allergan, InSite, Kala, Parion, Santen, ScienceBased Health, Shire PLC/SARcode and Sun. Please see the study for all other authors’ financial disclosures.
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