立他司特滴眼液说明书？

Main diseases

It can bind to integrin LFA-1 and block the effect of LFA-1 and its cognate ligand intercellular adhesion molecule-1 (ICAM-1). In vitro studies have shown that lifitegrast eye drops can inhibit the adhesion of T cells to ICAM-1 in human T cell lines, and can inhibit the secretion of inflammatory cytokines in human peripheral blood mononuclear cells. lifitegrast has a unique mechanism of action that blocks specific signaling pathways in inflammation and is suitable for the treatment of dry eye syndrome.

In a 12-week, phase III, randomized, double-blind, multicenter, placebo-controlled study, subjects were randomized in a 1:1 ratio to receive 5.0% Litalast eye drops (n=355) or placebo (n=356) twice daily for 84 days.

On Day 84, subjects treated with Ritalast eye drops had significantly greater improvements in EDS than baseline levels compared to subjects receiving placebo. The mean change in EDS from baseline was also significant in favor of Ritalast eye drops on day 42.

No statistically significant differences in ODS were observed between treatment groups at days 84, 42, or 14. Greater improvements in pruritus, foreign body sensation, and ocular discomfort were observed on Day 42 in participants treated with Ritalast eye drops compared with participants who received placebo.

Ritalast eye drops significantly improved dry eye symptoms in patients with DED compared with placebo. Improvement in EDS was observed as early as day 14 and was well tolerated.

Ritalast eye drops have a novel mechanism of action and are safe and effective in the treatment of dry eye. Ritalast eye drops can be an option for patients with dry eye who have insufficient response to artificial tears.

Use a disposable container to instill one drop of Ritalast eye drops into each eye twice a day, approximately 12 hours apart. Dispose of the disposable container immediately after use in each eye. Contact lenses should be removed before using Ritalast eye drops and put back on 15 minutes after use.

side effects

The most common adverse reactions (incidence rate 5%-25%) of using Litalast eye drops are irritation at the instillation site, taste disturbance and vision loss, and the serious side effect is allergy.

Rare cases of severe allergies include anaphylaxis, bronchospasm, respiratory distress, pharyngeal edema, tongue swelling, hives, allergic conjunctivitis, dyspnea, angioedema, and atopic dermatitis. Eye swelling and rash have also been reported.

If you develop wheezing, difficulty breathing, or a swollen tongue, seek medical attention immediately.

References:

Holland EJ, Luchs J, Karpecki PM, Nichols KK, Jackson MA, Sall K, Tauber J, Roy M, Raychaudhuri A, Shojaei A. Lifitegrast for the Treatment of Dry Eye Disease: Results of a Phase III, Randomized, Double-Masked, Placebo-Controlled Trial (OPUS-3). Ophthalmology. 2017 Jan;124(1):53-60. doi: 10.1016/j.ophtha.2016.09.025. Epub 2016 Oct 27. PMID: 28079022.

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