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Seattle, WA, United States

Background: The purpose of this study was to evaluate the safety and efficacy of thymosin beta 4 ophthalmic solution (RGN-259; Tβ4) in subjects with moderate to severe dry eye using the CAE™ model. Methods: This single-center, prospective, double-masked, placebo-controlled Phase II study randomized 72 qualifying subjects 1:1 to receive either 0.1% Tβ4 or placebo treatment for a total of 28 days. The study consisted of six visits over a 32-day period, including a screening visit (day -1), controlled adverse environment challenge (CAE) visits (day 1, day 28), and follow-up visits (days 14, 29, and 30). The primary efficacy endpoints were ocular discomfort scores and inferior corneal staining measured at visit 5 on day 29. Secondary endpoints included central and superior corneal staining, conjunctival staining, conjunctival redness, tear-film break-up time, and daily symptom scores recorded over the course of the study. Safety measures included visual acuity, slit-lamp evaluation, conjunctival redness, tear film break-up time, intraocular pressure, dilated funduscopy, and corneal sensitivity. Results: Neither of the primary endpoints, ie, ocular discomfort or inferior corneal staining, showed a significant difference between treatment and control groups at visit 5. Despite this, significant differences between treatment groups were observed for a number of secondary endpoints. The discomfort scores in the CAE on day 28 were reduced by 27% in 0.1% Tβ4-treated subjects compared with the placebo group (P=0.0244). Subjects in the 0.1% Tβ4 treatment group also showed statistically significant improvements in central and superior corneal staining compared with staining scores in the control group (P=0.0075 and P=0.0210). No adverse events were observed. Conclusion: This study confirms the efficacy of 0.1% Tβ4 as a topical treatment for relief of signs and symptoms of dry eye. Significant improvements in both signs and symptoms of dry eye were observed, and the treatment exhibited a large safety window, with no adverse events reported by any subjects enrolled in the study. © 2015 Sosne and Ousler.

Martin J.G.,ORA Inc | Cassatt K.B.,Genesis Centre | Kincaid-Cinnamon K.A.,Genesis Centre | Westendorf D.S.,Genesis Health System | And 2 more authors.
Journal of Arthroplasty | Year: 2014

Major blood loss is a known potential complication in total hip and total knee arthroplasty. We conducted a prospective, stratified, randomized, double-blind, placebo-controlled trial that evaluated 100 patients undergoing total knee or total hip arthroplasty to evaluate the effect on blood loss using the topical application of tranexamic acid. Participants received either 2. g of topical tranexamic acid or the equivalent volume of placebo into the joint prior to surgical closure. Tranexamic acid resulted in a lower mean maximum decline in postoperative hemoglobin levels when compared to placebo (P= 0.013). Patients in the tranexamic acid group demonstrated an improved but non-significant reduction in the units of blood transfused compared to placebo (P= 0.423). There was no clinically significant increase in complications in the tranexamic acid group, including no incidence of venous thromboembolism. © 2014 Elsevier Inc.

Gomes P.J.,ORA Inc
Current Opinion in Allergy and Clinical Immunology | Year: 2014

Purpose of review: This review describes recent findings and trends in prevalence and treatment of allergic ocular diseases. Although the major focus is on seasonal and perennial allergic conjunctivitis, related disorders will also be considered. Recent findings: Published reports from countries around the world suggest that the spectrum of atopic diseases, including seasonal and perennial allergic conjunctivitis, is continuing its pattern of increasing prevalence, which has been well documented over the past few decades. In addition, although treatment modalities have focused on topical formulations including antihistamines and corticosteroids, there is a significant emphasis on immunotherapy as an alternative treatment modality, particularly in the USA. Summary: Allergic conjunctivitis is a key component in the spectrum of allergic diseases that is sometimes collectively referred to as rhinoconjunctivitis. Because of its high prevalence worldwide, it exacts an increasing toll in terms of patient discomfort, morbidity, and loss of productivity. Current estimates suggest that at least 20% of the overall population suffers from some form of allergic conjunctivitis, many without ever seeking treatments. In addition, a significant proportion of patients experience chronic forms of allergy that are less responsive to existing therapies. Recent approval of immunotherapy-based treatments may address this therapeutic gap. © 2014 Wolters Kluwer Health | Lippincott Williams & Wilkins.

ORA Inc | Date: 2011-08-15

This is directed to systems, processes, machines, and other means that simulate blast waves from explosive events. The invention can make waveforms tailored to a users preference to accurately model a variety of explosive events by utilizing a driver section and a transition section that have divergent geometries.

The present invention provides topical ophthalmic formulations comprising a combination of one or more antihistamine agents and optionally one or more vasculature modifying agents such as a adrenergic receptor antagonist. Also provided are methods of using the formulations of the invention for treating and/or preventing symptoms associated with migraine headache, and for reducing the frequency, severity and duration of migraine attacks.

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