The safety and efficacy of alcaftadine 0.25% ophthalmic solution for the prevention of itching associated with allergic conjunctivitis.

OBJECTIVE: The purpose of this study was to evaluate the safety and clinical efficacy of alcaftadine 0.25% ophthalmic solution, a new topical anti-allergic agent for the prevention of the signs and symptoms of allergic conjunctivitis induced by conjunctival allergen challenge (CAC). STUDY DESIGN AND METHODS: This two-arm, double-masked, multi-center, placebo-controlled Phase III study (NCT00889330) enrolled healthy volunteers (N = 58) with a history of allergic conjunctivitis. Subjects ≥10 years of age with a reproducible, positive reaction to a CAC were randomized to receive either one drop of alcaftadine 0.25% ophthalmic solution bilaterally or vehicle bilaterally. After 16 hours (Visit 3) and 15 minutes (Visit 4), a CAC was performed and ocular and nasal symptoms of allergy were graded over a 20-minute period. Clinical and statistical significance were evaluated. MAIN OUTCOME MEASURES: The primary endpoints were ocular itching and conjunctival redness. The secondary endpoints were all other signs and symptoms of allergic conjunctivitis. Visual acuity, slit lamp biomicroscopy and adverse event reporting were the predetermined safety measures. RESULTS: Alcaftadine was effective in the prevention of ocular itching based on both clinically relevant and statistically significant differences compared with vehicle (placebo). Alcaftadine significantly reduced conjunctival redness, and almost all other allergic signs and symptoms at both 15 minutes and 16 hours after drug administration. No significant safety issues were reported. Between-group differences in ocular itching were higher 16 hours after drug administration than at 15 minutes after drug administration. CONCLUSIONS: With an onset of action within 3 minutes and a duration of action of at least 16 hours, the statistically and clinically significant effect of alcaftadine 0.25% on itching make it an important addition to therapy for ocular allergy. Additional studies are warranted to better understand the mechanisms affording a fast onset and prolonged duration of action.

Comparison of the efficacy and tolerability of preservative-free and preservative-containing formulations of the dorzolamide/timolol fixed combination (COSOPT™) in patients with elevated intraocular pressure in a randomized clinical trial.

BACKGROUND: The aim of this study was to compare the efficacy and tolerability of preservative-free (PF) and preservative-containing (PC) formulations of the dorzolamide/timolol fixed combination (COSOPT™) in patients with elevated intraocular pressure (IOP). METHODS: A parallel, randomized, double-masked study was conducted. After a 3-week run-in on timolol, patients with ocular hypertension, as confirmed by an IOP ≥22 mmHg, were randomized 1:1 to receive PF or PC dorzolamide/timolol twice daily for 12 weeks. IOP was measured at hour 0 (drug trough) and hour 2 (drug peak) at baseline (last day of 3-week timolol run-in), and weeks 2, 6 and 12. RESULTS: A total of 261 patients were randomized. Mean baseline IOPs were 23.7 mmHg for both treatments at hour 0 and 21.2 mmHg for PF dorzolamide/timolol and 21.4 mmHg for PC dorzolamide/timolol at hour 2. At all study time points (trough and peak at weeks 2, 6, and 12), the difference between treatments in mean change from baseline IOP was <0.5 mmHg. The 95% confidence intervals for the estimated treatment difference (PF minus PC) in mean change from baseline IOP at week 12 was -0.86 to 0.23 mmHg for trough (primary endpoint) and -0.39 to 0.67 mmHg for peak (secondary endpoint). The most common adverse events were ocular burning/stinging, reported by 16.0% and 21.5% of patients receiving PF and PC dorzolamide/timolol respectively, and taste perversion, reported by 3.1% and 5.4% of patients receiving PF and PC dorzolamide/timolol respectively. CONCLUSIONS: In patients with elevated IOP, PF and PC dorzolamide/timolol were equivalent in efficacy for change in trough and peak IOP, and had generally similar tolerability.

Impact of nasal congestion on quality of life and work productivity in allergic rhinitis: findings from a large online survey.

BACKGROUND: Allergic rhinitis is the most common allergic disease in the US. The predominant symptom of this condition is nasal congestion, which has a significant impact on quality of life and work productivity. This large survey was conducted to determine the impact of nasal congestion on the above parameters in individuals with allergic rhinitis, and treatment patterns for this symptom. METHODS: Participants were recruited voluntarily via telephone surveys and internet advertisements. Respondents with nasal congestion as a symptom of their allergic rhinitis (or who were primary caregivers to a child with nasal congestion associated with allergic rhinitis) were eligible for participation and completed a 52-question internet survey. Data were normalized to the US adult population using a weighting algorithm. RESULTS: Of the 2355 individuals with allergic rhinitis screened for participation in the survey, 2002 (85%) had nasal congestion. This was considered severe by 40% of respondents, compared with fewer than 30% who considered any other individual allergy symptom to be severe. Nasal congestion was the symptom that most adults and children wished to prevent, and it affected most respondents at work or school, had a notable emotional impact, and interfered with their ability to perform daily activities. Only 13% of participants receiving allergic rhinitis medication of any type, including over-the-counter medications, claimed to be very satisfied with treatment, and only 20% adhered completely to prescribing instructions. Although intranasal corticosteroids are recommended as first-line therapy for nasal congestion, only 30% of respondents with severe nasal congestion received treatment with intranasal corticosteroids. CONCLUSIONS: Nasal congestion affects most individuals with allergic rhinitis, and has a notable impact on quality of life, emotional function, productivity, and the ability to perform daily activities. Patients need to be better educated on the appropriate use of medications, particularly intranasal corticosteroids, to manage their nasal congestion.

Effects of mometasone furoate dry powder inhaler and beclomethasone dipropionate hydrofluoroalkane and chlorofluorocarbon on the hypothalamic-pituitary-adrenal axis in asthmatic subjects.

STUDY OBJECTIVES: Mometasone furoate dry powder inhaler (MF-DPI) [400 mug] is an inhaled corticosteroid (ICS) that is effective in the treatment of asthma. MF-DPI has a low potential for suppression of the hypothalamic-pituitary-adrenal (HPA) axis at its clinical dose. The effect of MF-DPI, 400 microg qd, on the HPA axis was compared to that of beclomethasone dipropionate (BDP) using hydrofluoroalkane (HFA) and chlorofluorocarbon (CFC) propellants via metered-dose inhalers (MDIs) twice daily. DESIGN AND INTERVENTIONS: This randomized, third-party blind, parallel-group study compared the effects of MF-DPI 400 mug one puff qd in the morning (n = 18), HFA-BDP 200 microg two puffs MDI bid (n = 18), and CFC-BDP 400 microg two puffs MDI bid (n = 17) for 14 days on the area under the 24-h serum cortisol concentrations curve (AUC(0-24)) and on total 24-h urinary free cortisol excretion in mild asthmatic subjects. Effects on morning/evening peak expiratory flow (PEF) and on inhaled albuterol use were also assessed. Adverse events that occurred during or > or = 30 days after the study were recorded. RESULTS: The mean decrease from baseline in the serum cortisol concentrations AUC(0-24) in the MF-DPI group was significantly less than in either the HFA-BDP (p = 0.024) or the CFC-BDP (p = 0.011) groups. Decreases in serum cortisol concentrations AUC(0-24) in the two BDP groups did not differ from one another. The MF-DPI group trended toward higher morning and evening PEF than either BDP group. Treatment-associated adverse events were reported by seven subjects in the MF-DPI group, vs one subject in the HFA-BDP and three subjects in the CFC-BDP groups; these were mild, and no subject discontinued treatment due to an adverse event. CONCLUSIONS: Fourteen days of treatment with MF-DPI 400 microg qd was associated with a significantly lesser decrease in the serum cortisol concentrations AUC(0-24) compared with HFA-BDP 200 microg MDI or CFC-BDP 400 microg MDI bid.