Elestat (Epinastine Hydrochloride Ophthalmic) - Summary

ELESTAT SUMMARY

ELESTAT^®
(epinastine HCl ophthalmic solution) 0.05%
Sterile

ELESTAT™ (epinastine HCl ophthalmic solution) 0.05% is a clear, colorless, sterile isotonic solution containing epinastine HCl, an antihistamine and an inhibitor of histamine release from the mast cell for topical administration to the eyes.

ELESTAT™ ophthalmic solution is indicated for the prevention of itching associated with allergic conjunctivitis.

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NEWS HIGHLIGHTS

Published Studies Related to Elestat (Epinastine Ophthalmic)

Efficacy of olopatadine HCI 0.1%, ketotifen fumarate 0.025%, epinastine HCI 0.05%, emedastine 0.05% and fluorometholone acetate 0.1% ophthalmic solutions for seasonal allergic conjunctivitis: a placebo-controlled environmental trial. [2009.08]
PURPOSE: We aimed to compare the clinical efficacy and ocular surface variables of olopatadine, ketotifen fumarate, epinastine, emedastine and fluorometholone acetate ophthalmic solutions in preventing the signs and symptoms of seasonal allergic conjunctivitis (SAC)... CONCLUSIONS: In patients with SAC, olopatadine, ketotifen, epinastine and emedastine are more efficacious than fluorometholone acetate in preventing itching and redness. All the antiallergic agents gave similar results in terms of reducing tearing, chemosis and eyelid swelling. Our data showed that impression cytology parameters improved after treatment with antiallergic agents in patients with SAC.

Efficacy of olopatadine HCI 0.1%, ketotifen fumarate 0.025%, epinastine HCI 0.05%, emedastine 0.05% and fluorometholone acetate 0.1% ophthalmic solutions for seasonal allergic conjunctivitis: a placebo-controlled environmental trial. [2008.07.08]
Purpose: We aimed to compare the clinical efficacy and ocular surface variables of olopatadine, ketotifen fumarate, epinastine, emedastine and fluorometholone acetate ophthalmic solutions in preventing the signs and symptoms of seasonal allergic conjunctivitis (SAC)... Our data showed that impression cytology parameters improved after treatment with antiallergic agents in patients with SAC.

An open-label, investigator-masked, crossover study of the ocular drying effects of two antihistamines, topical epinastine and systemic loratadine, in adult volunteers with seasonal allergic conjunctivitis. [2007.04]
BACKGROUND: Systemic antihistamines such as loratadine are efficacious in the treatment of many allergic conditions. However, their use has been associated with drying effects, particularly of the ocular surface. Objective: The purpose of this study was to compare the ocular drying effects of topical treatment with epinastine hydrochloride ophthalmic solution 0.05 % twice daily and systemic treatment with loratadine 10 mg once daily in patients with seasonal allergic conjunctivitis through the use of several standard clinical tests for dry eye... CONCLUSIONS: These healthy adult volunteers with a history of seasonal allergic conjunctivitis had no clinical signs of ocular drying after 4 days of twice-daily treatment with topical epinastine. After 4 days of once-daily dosing, systemic loratadine was associated with clinical signs of ocular dryness, including decreased tear volume and tear flow. Use of loratadine was also associated with an increase in global fluorescein staining, indicating an increase in ocular surface damage.

Clinical efficacy of olopatadine vs epinastine ophthalmic solution in the conjunctival allergen challenge model. [2004.08]
CONCLUSION: Olopatadine is significantly more effective than epinastine in controlling itching, redness and chemosis associated with allergic conjunctivitis in the CAC model.

Efficacy and tolerability of ophthalmic epinastine assessed using the conjunctival antigen challenge model in patients with a history of allergic conjunctivitis. [2004.01]
BACKGROUND: Epinastine hydrochloride is a nonsedating antihistamine with a high affinity for histamine H(1) receptors, together with mast cell-stabilizing and anti-inflammatory activities. OBJECTIVE: The aim of this study was to assess the efficacy and tolerability of topically administered ophthalmic epinastine using the conjunctival antigen challenge (CAC) model in patients with a history of allergic conjunctivitis... CONCLUSIONS: In this CAC model, multiple signs and symptoms of allergic conjunctivitis were significantly reduced by instillation of epinastine compared with vehicle. Epinastine showed prompt onset (3 minutes) and long duration of action (>or=8 hours). The tolerability of epinastine was similar to that of vehicle.

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Clinical Trials Related to Elestat (Epinastine Ophthalmic)

Safety and Efficacy Study of Epinastine Nasal Spray in Subjects With Seasonal Allergic Rhinitis [Completed]
The purpose of this study is to determine the safety and efficacy of epinastine nasal spray compared to placebo for the treatment of subjects with seasonal allergic rhinitis

Non-Pharmaceutical Treatment of Seasonal Allergic Conjunctivitis [Recruiting]
Seasonal allergic conjunctivitis (SAC) is an irritating eye condition that affects many people, caused by hypersensitivity to normally harmless substances such as pollen, and often accompanies seasonal hay fever. Treatments that can be used before initiating medical therapy include artificial tear supplements (ATS) and cold compresses (CC). However, there is no evidence in the scientific literature that demonstrates their efficacy compared to no treatment or their combined effect with anti-allergic medication. Therefore the investigators aim to examine the efficacy of ATS and CC alone, in comparison to anti-allergic medication, and CC in combination with anti-allergic medication. In addition, the investigators also aim to determine the time course of ocular allergic reactions. At the end of the study the investigators will be able to see whether or not ATS and CC are effective in treating SAC.

A Study of Epinastine Nasal Spray in Subjects With Seasonal Allergic Rhinitis [Completed]
The purpose of this trial is to determine the safety, efficacy and tolerability of two doses of the study drug compared to placebo for the treatment of subjects with seasonal allergic rhinitis.

Comparison of CL Wear Between Two Allergy Drops [Not yet recruiting]
Comparison of two allergy drops for enhancing comfort and performance of contact lens wear

Study of Two Marketed Ocular Anti-Allergy Medications in Subjects With Allergic Conjunctivitis [Completed]
The purpose of this study is to compare the effects of two marked ocular anti-allergy medications in cat sensitive subjects with allergic conjunctivitis.

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