Optivar (Azelastine Hydrochloride Ophthalmic) - Summary

OPTIVAR SUMMARY

OPTIVAR^®

azelastine hydrochloride
ophthalmic solution, 0.05%

OPTIVAR^® (azelastine hydrochloride ophthalmic solution), 0.05% is a sterile ophthalmic solution containing azelastine hydrochloride, a relatively selective H₁-receptor antagonist for topical administration to the eyes.

OPTIVAR^® is indicated for the treatment of itching of the eye associated with allergic conjunctivitis.

See all Optivar indications & dosage >>

NEWS HIGHLIGHTS

Published Studies Related to Optivar (Azelastine Ophthalmic)

MP29-02 (a novel intranasal formulation of azelastine hydrochloride and fluticasone propionate) in the treatment of seasonal allergic rhinitis: a randomized, double-blind, placebo-controlled trial of efficacy and safety. [2012]
Many patients with allergic rhinitis (AR) have uncontrolled symptoms despite available treatment options. This study was designed to evaluate the efficacy and safety of MP29-02 (a novel intranasal formulation of fluticasone propionate [FP] and azelastine [AZ] hydrochloride), compared with monotherapy with FP, AZ, and placebo sprays for the treatment of seasonal allergic rhinitis (SAR)...

Two-week comparison study of olopatadine hydrochloride nasal spray 0.6% versus azelastine hydrochloride nasal spray 0.1% in patients with vasomotor rhinitis. [2011.03]
Olopatadine hydrochloride nasal spray 0.6% (OLO) and azelastine nasal spray 137 micrograms (AZE) are effective in treating allergic rhinitis and AZE is indicated for nonallergic vasomotor rhinitis (VMR). This study evaluates the relative safety and efficacy of OLO and AZE in patients with VMR.

Double-blind, placebo-controlled study of azelastine and fluticasone in a single nasal spray delivery device. [2010.08]
BACKGROUND: A proof-of-concept study suggested that combination therapy with commercial azelastine hydrochloride nasal spray and fluticasone propionate nasal spray significantly improved nasal symptoms of seasonal allergic rhinitis compared with either agent alone. OBJECTIVE: To compare an azelastine-fluticasone combination nasal spray administered in a single-delivery device with a commercially available azelastine nasal spray and fluticasone nasal spray... CONCLUSIONS: The combination azelastine-fluticasone nasal spray provided statistically significant improvement in the TNSS and additive clinical benefit compared with either agent alone in patients with moderate-to-severe seasonal allergic rhinitis. TRIAL REGISTRATION: clinicaltrials.gov Identifier: NCT00660517. Copyright 2010 American College of Allergy, Asthma & Immunology. Published by Elsevier Inc. All rights reserved.

Comparison of azelastine versus triamcinolone nasal spray in allergic and nonallergic rhinitis. [2010.01]
BACKGROUND: Intranasal antihistamine has not been thoroughly studied in the treatment of rhinitis of different etiologies. This study was designed to show the comparative efficacy of nasal antihistamine and nasal corticosteroid in patients with allergic rhinitis (AR) and nonallergic rhinitis (NAR)... CONCLUSION: In this first comparative demonstration, AZENS appears to be as effective as triamcinolone in symptom scores, nPIFR, ESS, and HRQoL, equally in AR and NAR.

Double-blind, placebo-controlled study of azelastine and fluticasone in a single nasal spray delivery device. [2010]
nasal spray and fluticasone nasal spray... CONCLUSIONS: The combination azelastine-fluticasone nasal spray provided

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Clinical Trials Related to Optivar (Azelastine Ophthalmic)

Single Dose Pharmacokinetics of Intranasal Azelastine Delivered by a Fixed Combination With Fluticasone in Comparison to Azelastine Nasal Sprays [Completed]
The primary objective is to assess the effect of fluticasone propionate (FLU) on the relative bioavailability (AUC0-∞) of azelastine hydrochloride (AZE) when administered as fixed AZE-FLU combination product (TEST) compared to a similar formulation without containing FLU (i. e. AZE alone; REF). The secondary objectives are to compare the relative bioavailability (AUC0-∞) of AZE when administered either as fixed AZE-FLU combination product (TEST) or as marketed AZE product Astelin® Nasal Spray (COMP); To compare the effects of FLU on other pharmacokinetic parameters of AZE (AUC0-tlast, CL/f, Cmax, tmax, t½); To assess adverse events.

Single Dose Pharmacokinetics of Intranasal Fluticasone Delivered by a Fixed Combination With Azelastine (MP29 02) in Comparison to Two Different Fluticasone Nasal Sprays [Completed]
The primary objective is to assess the effect of azelastine hydrochloride (AZE) on the relative bioavailability (AUC0-∞) of fluticasone propionate (FLU) when administered as fixed AZE-FLU combination product (TEST) compared to a similar formulation without containing AZE (i. e. FLU alone in the MP29-02 vehicle; REF). The secondary objectives are to compare the relative bioavailability (AUC0-∞) of FLU when administered either as fixed AZE-FLU combination product (TEST) or as marketed FLU product, Fluticasone Propionate Nasal Spray, Roxane Laboratories (COMP); To compare the effects of AZE on other pharmacokinetic parameters of FLU (AUC0 tlast, CL/f, Cmax, tmax, t½); To assess adverse events.

Compare Captisol-Enabled (CE) Budesonide + Azelastine Nasal Solution and Rhinocort Aqua + Astelin in an Environmental Exposure Chamber (EEC) Study of Allergic Rhinitis [Completed]
The primary objective of this study was to compare Placebo to Captisol-Enabled Budesonide + Azelastine in a single spray and two separate sprays (Budesonide + Azelastine) in patients with Seasonal Allergic Rhinitis exposed to controlled ragweed pollen.

A Study to Evaluate the Safety and Efficacy of a Nasal Spray to Treat Seasonal Allergies [Completed]
The Purpose of this study is to evaluate the safety and efficacy of MP03-36 (0. 15% azelastine hydrochloride)at dosages of 2 sprays per nostril once daily and 2 sprays per nostril twice daily in patients with seasonal allergic rhinitis.

A Study to Evaluate the Safety and Effectiveness of a Nasal Spray to Treat Seasonal Allergies [Completed]
The purpose of this study is to determine if two allergy medications (azelastine and fluticasone) are more effective than placebo or either medication alone (azelastine or fluticasone)

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PATIENT REVIEWS / RATINGS / COMMENTS

Optivar review by 36 year old female patient
		Rating
Overall rating:
Effectiveness:		Considerably Effective
Side effects:		Moderate Side Effects
		Treatment Info
Condition / reason:		dry, allergic eyes
Dosage & duration:		1 drop 2x/day (dosage frequency: 1x) for the period of 1x
Other conditions:		eye fatigue
Other drugs taken:		none
		Reported Results
Benefits:		relieved some of the itching
Side effects:		blurred vision for 90 seconds after administering; burning sensation
Comments:		Was prescribed for 1 month for dry, itchy eyes. I took Optivar for 5 days, then called the ophtamologist about the burning sensation. He advised me to discontinue the Optivar and wrote a prescription for Alrex.