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Ketotifen Hydrogen Fumarate

This article discusses a Phase III clinical trial investigating the use of Ketotifen Hydrogen Fumarate eye drops for treating seasonal allergic conjunctivitis (SAC). The study aims to evaluate the efficacy and safety of a 0.5 mg/ml Ketotifen ophthalmic solution compared to a vehicle (placebo) and an active control (Ketoftil) in managing SAC symptoms. This multicentre, randomized, double-blind trial focuses on assessing various aspects of eye discomfort and inflammation associated with seasonal allergies.

Table of Contents

What is Ketotifen Hydrogen Fumarate?

Ketotifen Hydrogen Fumarate is a medication used to treat seasonal allergic conjunctivitis, a common eye condition caused by allergies[1]. It’s also known by its synonym, Ketotifen Fumarate. This drug is classified as an ophthalmologic antiallergic agent, which means it’s specifically designed to treat eye allergies[1].

Medical Condition: Seasonal Allergic Conjunctivitis

Seasonal Allergic Conjunctivitis (SAC) is an eye condition that occurs during specific times of the year, usually when certain pollens are in the air. Symptoms can include:

  • Redness in the eyes
  • Tearing or watery eyes
  • Itchy eyes
  • Swelling of the eyelids
  • Conjunctival chemosis (swelling of the clear membrane covering the white part of the eye)
These symptoms can be uncomfortable and interfere with daily activities[1].

How Ketotifen Works

Ketotifen works as an antihistamine and mast cell stabilizer. Here’s what this means:

  • Antihistamine: It blocks the effects of histamine, a substance your body releases during an allergic reaction that causes itching and inflammation.
  • Mast cell stabilizer: It prevents mast cells (a type of immune cell) from releasing substances that cause allergic symptoms.
By working in these two ways, Ketotifen helps reduce the symptoms of eye allergies[1].

Administration and Dosage

Ketotifen is typically administered as eye drops. In the current study, it’s being tested as a 0.5 mg/ml ophthalmic solution. The maximum daily dose amount is 0.1 mg/ml, with a maximum total dose amount of 1.4 mg/ml over a 2-week period[1]. Always follow your doctor’s instructions or the label on the medication for proper usage.

Current Clinical Study

A clinical trial is currently underway to evaluate the efficacy and safety of Ketotifen ophthalmic solution for treating seasonal allergic conjunctivitis. This study is:

  • Multicentre: Conducted at multiple research sites
  • Randomised: Participants are randomly assigned to different treatment groups
  • Double-blind: Neither the participants nor the researchers know who is receiving which treatment
  • Vehicle and active-controlled: Comparing Ketotifen to both a placebo (vehicle) and another active treatment (Ketoftil)
This rigorous study design helps ensure the results are reliable and unbiased[1].

Eligibility Criteria for the Study

To participate in this study, patients must meet certain criteria. Some key inclusion criteria are:

  • Adults aged 18 to 65 years old
  • Diagnosed with seasonal allergic conjunctivitis within the past 12 months
  • Currently experiencing symptoms of SAC
Some exclusion criteria include:
  • Other eye conditions besides SAC
  • Poor visual acuity
  • Recent use of certain medications that could interfere with the study results
  • Pregnancy or breastfeeding
These criteria help ensure the study results are applicable to the intended patient population[1].

Study Endpoints: What’s Being Measured

The study is measuring several outcomes to determine how well Ketotifen works:

  • Primary endpoint: Change in ocular itching from baseline to 14 days after starting treatment
  • Secondary endpoints: Changes in conjunctival redness, tearing, eyelid swelling, and conjunctival chemosis at various time points
  • Product tolerability and safety
These measurements will help determine how effective and safe Ketotifen is for treating SAC[1].

Important Considerations and Precautions

While Ketotifen can be effective for treating SAC, there are some important things to consider:

  • It should not be used by people with hypersensitivity to antiallergic agents or any ingredients in the medication.
  • It’s not recommended for use with contact lenses.
  • Women who are pregnant, breastfeeding, or planning to become pregnant should consult their doctor before using this medication.
  • It may interact with other medications, so inform your doctor about all drugs you’re taking.
Always consult with a healthcare professional before starting any new medication[1].

Aspect Details
Study Type Phase III, multicentre, randomized, double-blind, vehicle and active-controlled
Medication Tested Ketotifen ophthalmic solution 0.5 mg/ml
Comparators Vehicle (placebo) and Ketoftil (active control)
Condition Seasonal Allergic Conjunctivitis (SAC)
Primary Endpoint Ocular itching score change from baseline to day 14
Secondary Endpoints Conjunctival redness, tearing, eyelid swelling, conjunctival chemosis, product tolerability, safety evaluation
Treatment Duration 14 days
Key Inclusion Criteria Adults 18-65 years, SAC diagnosis, active symptoms
Key Exclusion Criteria Other eye conditions, poor vision, recent eye surgery, certain medication use, pregnancy

FAQ

  • What is the main purpose of this clinical trial? The main purpose of this clinical trial is to evaluate the effectiveness and safety of Ketotifen eye drops (0.5 mg/ml) compared to a placebo and an existing treatment (Ketoftil) for seasonal allergic conjunctivitis.
  • Who can participate in this study? Adults aged 18 to 65 years with a diagnosis of seasonal allergic conjunctivitis, confirmed by a skin test or IgE test, and experiencing at least one symptom such as redness, tearing, itchy eyes, eyelid swelling, or conjunctival chemosis can participate in the study.
  • What are the main symptoms being evaluated in this trial? The main symptoms being evaluated are ocular itching, conjunctival redness, tearing, eyelid swelling, and conjunctival chemosis. These symptoms will be assessed at various time points throughout the study.
  • How long does the treatment period last in this trial? The treatment period in this trial lasts for 14 days, with assessments made at baseline, 30 minutes after the first dose, and then at 2, 7, and 14 days after starting treatment.
  • What are some reasons why someone might not be able to participate in this study? Some reasons for exclusion include having other eye conditions besides SAC, poor vision, recent eye surgery, use of certain medications, pregnancy or breastfeeding, and participation in other clinical trials within the past 30 days.

Ongoing Clinical Trials on Ketotifen Hydrogen Fumarate

  • Study on Ketotifen Eye Drops for Treating Seasonal Allergic Conjunctivitis in Patients

    Not recruiting

    3 1 1
    Investigated drugs:
    Italy

Glossary

  • Seasonal Allergic Conjunctivitis (SAC): An eye condition caused by an allergic reaction to seasonal allergens like pollen, resulting in itchy, red, and watery eyes.
  • Ketotifen Hydrogen Fumarate: An antihistamine medication used in eye drops to treat allergy symptoms in the eyes.
  • Phase III Clinical Trial: A large-scale study to confirm the effectiveness and safety of a new treatment compared to existing treatments or placebos.
  • Placebo: A substance with no active ingredients, used as a control in clinical trials to compare against the effects of the actual medication.
  • Double-blind: A study design where neither the participants nor the researchers know who is receiving the actual treatment or the placebo.
  • Conjunctival Chemosis: Swelling of the clear membrane that covers the white part of the eye and the inner surface of the eyelid.
  • Visual Analog Scale (VAS): A measurement tool used to assess subjective characteristics or attitudes that cannot be directly measured.
  • IgE (Immunoglobulin E): An antibody produced by the immune system in response to allergens, often measured to diagnose allergies.
  • Ophthalmic: Relating to the eyes or vision.

References

  1. http://clinicaltrials.eu/trial/study-on-ketotifen-eye-drops-for-treating-seasonal-allergic-conjunctivitis-in-patients/