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

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What is this study about?

This clinical trial is focused on studying the treatment of Seasonal Allergic Conjunctivitis, a common eye condition that occurs during certain times of the year and causes symptoms like itchy, red, and watery eyes. The study will evaluate the effectiveness and safety of an eye drop solution containing Ketotifen, a medication known to help relieve allergy symptoms. Two different formulations of Ketotifen eye drops are being tested: one is called Ketoftil, and the other is referred to by its code name KET-001. Additionally, a placebo will be used for comparison purposes.

The purpose of the study is to determine how well these Ketotifen eye drops work in reducing the symptoms of Seasonal Allergic Conjunctivitis and to ensure they are safe for use. Participants in the study will be randomly assigned to receive either the Ketotifen eye drops, Ketoftil, or a placebo. The study will last for a period of two weeks, during which participants will use the eye drops and report any changes in their symptoms. The study is designed to be double-blind, meaning neither the participants nor the researchers will know which treatment each participant is receiving, to ensure unbiased results.

Throughout the study, participants will be asked to self-assess their level of eye itching using a simple scale. Other symptoms, such as eye redness, tearing, and eyelid swelling, will be evaluated by the study investigators at various intervals. The overall safety and tolerability of the treatments will also be monitored. This trial aims to provide valuable information on the potential benefits of Ketotifen eye drops for individuals suffering from Seasonal Allergic Conjunctivitis.

1 joining the study

Upon joining the study, you will be randomly assigned to receive either the active medication, ketotifen ophthalmic solution 0.5 mg/ml, or a placebo. The placebo contains ingredients like glycerol, hydrochloric acid, and water for injections, but does not have the active medication.

The study is double-blind, meaning neither you nor the researchers will know which treatment you are receiving to ensure unbiased results.

2 medication administration

You will be instructed to use the eye drops as directed. The dosage is 0.5 mg/ml of ketotifen, administered through eye drops.

The frequency and duration of administration will be explained to you by the study team. Ensure to follow the instructions carefully for the entire duration of the study.

3 self-assessment of symptoms

You will be asked to self-assess your ocular itching using a 5-point scale. This will occur between the first visit (baseline) and the fifth visit, which is 14 days later.

Your feedback is crucial for evaluating the effectiveness of the treatment.

4 investigator assessments

The study team will assess your conjunctival redness at 30 minutes, 2 days, 7 days, and 14 days after the first administration of the eye drops. This will be done using a specific scale known as the Efron scale.

Other symptoms such as tearing, eyelid swelling, and conjunctival chemosis will also be evaluated at the same intervals using different scales.

5 product tolerability assessment

The tolerability of the product will be assessed at 30 minutes, 2 days, 7 days, and 14 days after the first administration. This will be done using a tool called the Visual Analog Scale (VAS).

Your comfort and any side effects experienced will be recorded to ensure the safety of the treatment.

6 safety evaluation

Throughout the study, any adverse events or side effects you experience will be documented. This is to ensure the safety of the treatment and to monitor any potential risks.

Both quantitative (numerical) and qualitative (descriptive) evaluations will be conducted to assess safety.

Who Can Join the Study?

Adult patient (age from 18 to 65 years old).
Diagnosis of Seasonal Allergic Conjunctivitis (SAC) confirmed through a skin test and/or a validated IgE radioallergosorbent test (RAST) to the relevant seasonal allergy for the geographic area within the past 12 months. IgE RAST is a blood test that helps identify specific allergies.
Experiencing symptoms or exceeding an appropriate minimum level of symptoms at the time of enrollment. Patients must have at least one of the following symptoms: redness, tearing, itchy eyes, eyelid swelling, or conjunctival chemosis with a grade score of one. Conjunctival chemosis is swelling of the tissue lining the inside of the eyelids and the white part of the eye.
Patient has given written informed consent approved by the Ethics Committee (EC). This means the patient agrees to participate in the study after being informed about it.

Who Cannot Join the Study?

Patients who are not diagnosed with seasonal allergic conjunctivitis cannot participate. This is an eye condition caused by allergies, leading to red, itchy, and watery eyes.
Patients who are younger than 4 years old or older than 3 years old cannot participate. This means the study is for children aged 4 to 3 years old.
Patients who are part of a vulnerable population cannot participate. A vulnerable population includes groups who may need special protection, like pregnant women or people with certain disabilities.

Where you can join this trial?

Verified and Recommended Sites

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Verified Sites

Site Name	City	Country	Status
Azienda Ospedaliera Universitaria Federico II Di Napoli	Naples	Italy
Fondazione Policlinico Universitario Agostino Gemelli IRCCS	Rome	Italy

Other Sites

Site Name	City	Country
Ospedale San Raffaele S.r.l.	Milan	Italy
Azienda Sociosanitaria Territoriale Santi Paolo E Carlo	Milan	Italy
Hospital Santa Maria Della Misericordia	Perugia	Italy
Ayedvro Ujszr Smjeqmaql Ljmfhj Dx Bxrnemx	Bologna	Italy

Trial status

Country	Status	Recruitment Start
Italy	Not recruiting	01.05.2023

Trial locations

Investigated drugs:

Ketotifen Hydrogen Fumarate

Ketotifen Ophthalmic Solution is an eye drop used to relieve symptoms of seasonal allergic conjunctivitis, which is an eye condition caused by allergies. This medication works by blocking certain natural substances in the body that cause allergic symptoms, such as itching and redness in the eyes. It helps to make your eyes feel more comfortable during allergy season.

Seasonal Allergic Conjunctivitis – Seasonal Allergic Conjunctivitis is an inflammation of the conjunctiva, the membrane covering the white part of the eyes and the inner side of the eyelids, caused by allergens such as pollen. It typically occurs during specific seasons when pollen levels are high. The condition is characterized by symptoms such as itching, redness, tearing, and swelling of the eyes. These symptoms result from the body’s immune response to allergens, leading to the release of histamines and other chemicals. The condition can cause discomfort and may interfere with daily activities, but it does not usually affect vision. Symptoms often improve when the exposure to allergens is reduced or eliminated.

Trial ID:

2023-503185-23-00

Protocol code:

KET-001

Trial Phase:

Therapeutic confirmatory (Phase III)

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

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