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MULTICENTRE, RANDOMISED, DOUBLE-BLIND, VEHICLE AND ACTIVE-CONTROLLED PHASE III STUDY EVALUATING THE EFFICACY AND SAFETY OF KETOTIFEN OPHTHALMIC SOLUTION 0.5 MG/ML COMPARED TO VEHICLE AND KETOFTIL (KETOTIFEN OPHTHALMIC SOLUTION 0.5 MG/ML) FOR THE TREATMENT OF SEASONAL ALLERGIC CONJUNCTIVITIS.
EU CTIS ID: 2023-503185-23-00
What this study is testing
MULTICENTRE, RANDOMISED, DOUBLE-BLIND, VEHICLE AND ACTIVE-CONTROLLED PHASE III STUDY EVALUATING THE EFFICACY AND SAFETY OF KETOTIFEN OPHTHALMIC SOLUTION 0.5 MG/ML COMPARED TO VEHICLE AND KETOFTIL (KETOTIFEN OPHTHALMIC SOLUTION 0.5 MG/ML) FOR THE TREATMENT OF SEASONAL ALLERGIC CONJUNCTIVITIS.
- Therapeutic confirmatory (Phase III)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- Adult patient (age from 18 to 65 years old).
- Diagnosis of SAC assess through skin test and/or validated IgE radioallergosorbent test (RAST) to the relevant seasonal allergy for the geographic area within the past 12 months.
- Experiencing symptoms or exceeding an appropriate minimum level of symptoms at the time of enrolment (Patients must have at least one of Redness, tearing, itchy eyes, eyelid swelling, conjunctival chemosis with a grade score of one)
- Patient has given written informed consent approved by the Ethics Committee (EC).
You likely can't join if
- Diagnosis of any ocular pathology other than acute SAC (dry eye, chronic allergic conjunctivitis, VKC, viral or bacterial conjunctivitis).
- Best corrected visual acuity (Snellen) in either eye worse than 20/100.
- Patients who have received anti-allergy immunotherapy (desensitising subjects with increase of allergen challenges) in the previous two years or are still receiving this kind of therapy.
- History of Hypersensitivity to other anti-allergic agents (including corticosteroids).
- Use of non-steroidal anti-inflammatory agents, mast cell stabilizers, antihistamines, decongestants, or α-adrenoreceptor antagonists.
- Use of topical (ocular) or systemic corticosteroids.
See the full eligibility criteria
- Adult patient (age from 18 to 65 years old).
- Diagnosis of SAC assess through skin test and/or validated IgE radioallergosorbent test (RAST) to the relevant seasonal allergy for the geographic area within the past 12 months.
- Experiencing symptoms or exceeding an appropriate minimum level of symptoms at the time of enrolment (Patients must have at least one of Redness, tearing, itchy eyes, eyelid swelling, conjunctival chemosis with a grade score of one)
- Patient has given written informed consent approved by the Ethics Committee (EC).
- Diagnosis of any ocular pathology other than acute SAC (dry eye, chronic allergic conjunctivitis, VKC, viral or bacterial conjunctivitis).
- Best corrected visual acuity (Snellen) in either eye worse than 20/100.
- Patients who have received anti-allergy immunotherapy (desensitising subjects with increase of allergen challenges) in the previous two years or are still receiving this kind of therapy.
- History of Hypersensitivity to other anti-allergic agents (including corticosteroids).
- Use of non-steroidal anti-inflammatory agents, mast cell stabilizers, antihistamines, decongestants, or α-adrenoreceptor antagonists.
- Use of topical (ocular) or systemic corticosteroids.
- Any other medical condition that could have interfered with the results of the study.
- History of Hypersensitivity related to the study IMPs, including any of the excipients.
- Female of potential child-bearing that does not use at least one effective contraceptive method for the entire study.
- Use of prostaglandin for Glaucoma treatments in the last 1 month.
- Use of cyclosporine eyedrops for severe dry eye.
- Female patient: pregnant, lactating or planning pregnancy within next 12 months (Female of child-bearing potential will undergo urine pregnancy test).
- Participation in a clinical trial in which an investigational drug or device was administered in the 30 days prior to screening or 5 half-lives of the study drug, whichever is longer.
- Patient legally or mentally incapacitated unable to give informed consent for the participation in this study.
- Patient who is unable or unwilling to comply with the appointments or with all the requirements of the Protocol.
- Use of contact lenses during the course of the study.
- History of ocular surgery or laser within the previous 3 months.
The study team makes the final eligibility decision.
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18-64 years, 65+ years. The study team makes the final eligibility decision.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.