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Zaditor (Ketotifen Fumarate Ophthalmic) - Summary

 
 



ZADITOR SUMMARY

Zaditor

ZADITOR™ is a sterile ophthalmic solution containing ketotifen for topical administration to the eyes.

ZADITOR™ (ketotifen fumarate ophthalmic solution) is indicated for the temporary prevention of itching of the eye due to allergic conjunctivitis.


See all Zaditor indications & dosage >>

NEWS HIGHLIGHTS

Published Studies Related to Zaditor (Ketotifen 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.

[Comparison of olopatadin and ketotifen in the treatment of allergic conjunctivitis] [2009.07]
OBJECTIVE: To compare the efficacy of olopatadine 0.1 % and ketotifen 0.025 % ophthalmic solutions in the treatment of allergic conjunctivitis... CONCLUSIONS: In this study, olopatadine 0.1 % was more effective than topical ketotifen 0.025 % in improving itching, tearing and burning in allergic conjunctivitis patients.

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.

Comparison of the effects of ketotifen fumarate 0.025% and olopatadine HCl 0.1% ophthalmic solutions in seasonal allergic conjunctivities: a 30-day, randomized, double-masked, artificial tear substitute-controlled trial. [2005.09]
BACKGROUND: Topical antiallergic agents, such as antihistamines and mast-cell stabilizers, are the main therapeutic options for seasonal allergic conjunctivitis (SAC). Ketotifen fumarate and olopatadine HCl have dual action that offers a combination of these 2 mechanisms. Although clinical studies comparing the efficacy of these 2 drugs have shown that both were effective in the treatment of SAC, the results were contradictory and did not include the effects of these drugs on inflammatory markers. OBJECTIVES: The aims of this study were to compare the clinical efficacy of topical ketotifen and olopatadine eye drops and to determine the effects of these 2 drugs on the expression of cell adhesion molecules (CAMs) and inflammatory markers in conjunctival surface cells in patients with SAC... CONCLUSIONS: In this short-term study in a selected, small study population with SAC, ketotifen and olopatadine diminished the expression of CAMs and inflammatory markers on the conjunctival surface cells effectively. Both active treatments were more efficacious compared with ATS and were well tolerated.

Efficacy and safety of single- and multiple-dose ketotifen fumarate 0.025% ophthalmic solution in a pediatric population. [2004.12]
Allergic conjunctivitis can seriously disrupt children's daily activities. This study assessed the efficacy (onset and duration of action) and safety of ketotifen fumarate 0.025% ophthalmic solution compared with vehicle placebo in pediatric subjects after single and multiple dosing... These results indicate that ketotifen fumarate 0.025% ophthalmic solution is an effective and safe treatment option for children with allergic conjunctivitis.

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Clinical Trials Related to Zaditor (Ketotifen Ophthalmic)

Novel Use of (Oral) Ketotifen for the Treatment of Fibromyalgia: A Pilot Study [Active, not recruiting]
The purpose of this 10-week study is to determine the effects of a medication called Ketotifen on inflammation (blood) markers; pain sensitivity; and fibromyalgia-related pain. Ketotifen works by inhibiting (to prevent or slow down) certain substances in the body that are known to cause inflammation. It is an antihistamine that reduces the harmful effects of histamine. The ophthalmic (eye drops) formulation of ketotifen has been approved by the Food and Drug Administration (FDA) and has been available in the United States for more than a decade. Oral (taken by mouth) ketotifen has been in available in other countries for several decades. Commonly prescribed for the maintenance treatment of asthma and allergic rhinitis, ketotifen has long track record of safety. To date, the oral form of ketotifen has not been approved by the FDA, therefore this study is referred to as an "investigational drug study." Prior to opening recruitment an "investigational new drug" (IND) application which included scientific data and information regarding human safety plans was submitted to and approved by the FDA.

Trial of Ketotifen in Children and Adolescents [Not yet recruiting]

This study is a double-blind, placebo - controlled, cross-over trial of ketotifen in children

ages 8 through 17 inclusive that have a diagnosis of Functional Dyspepsia and have had continued pain despite acid reduction therapy in combination with montelukast. This study is 147 days for subjects responsive to the ketotifen and 63 days for those who are not. The study includes scheduled visits including a physical, blood draws, and questionaires.

Investigations of Mechanisms and Treatment in Post-traumatic Joint Contractures [Recruiting]
Injured joints, especially at the elbow, are at risk for permanent motion loss, also known as joint contractures. Joint contractures limit the function of an elbow and are a recognized complication that occurs often after a traumatic injury. The benefits of early motion after injury has helped in preventing joint contractures but there are still several patients that develop debilitating joint contractures. Current research suggests that mast cells, which are found in the joint, are key in causing joint contractures. Research has been done using a medication called Ketotifen. Ketotifen has been linked to stabilizing mast cells and preventing the joint contracture. It is hoped that short-term use of this medication after an injury will prevent the contracture from occurring.

A Confirmatory Study of TAU-284 in Pediatric Patients With Atopic Dermatitis [Completed]

Ketotifen/Naphazoline Ophthalmic Solution in the Conjunctival Allergen Challenge Model of Acute Allergic Conjunctivitis. [Completed]

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Page last updated: 2010-10-05

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