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A Phase 3, Multicenter, Randomized, Double-Masked, Vehicle-Controlled Study to Demonstrate Efficacy and Safety of DFL24498 Eye Drop Solution in Adult Participants with Atopic Keratoconjunctivitis (AKC)
EU CTIS ID: 2025-522291-83-00
What this study is testing
To confirm the efficacy of DFL24498 ophthalmic solution in improving the symptom of ocular itching in participants with AKC after 6 weeks of treatment.
- 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
- Men or women aged ≥ 18 and ≤ 65 years of age.
- Diagnosis of AKC in both eyes, including the presence or medical history of the following: a. other atopic condition (ie,. atopic dermatitis, periocular eczema, asthma, allergic rhinitis), AND b. chronic allergic blepharoconjunctivitis and/or keratoconjunctivitis;
- Ocular itching of at least 50 as assessed by VAS scale.
- Corneal fluorescein staining assessed by modified Oxford scale of at least grade 1 AND a bulbar conjunctival hyperemia assessed by VBR 10 scale of at least 40 (range 0 to 100) in the same eye.
- A composite symptoms score (CSyS) ≥ 5 (sum of the severity scores graded 0 to 3 for each of the following: itching, tearing, ocular discomfort, photophobia, and mucous discharge score) (CSyS range of 0 to 15).
- If a woman of childbearing potential (WOCBP), must have a negative pregnancy test at both screening and baseline visit, and use an acceptable contraception method as described in the protocol.
You likely can't join if
- Inability to speak and understand the local language sufficiently to understand the nature of the study, to provide written informed consent, and to allow the completion of all study assessments
- Fertile men (ie, not surgically sterilized by vasectomy) unwilling to use an acceptable form of contraception (male condom with spermicidal cream or jelly) during the entire course of and 30 days after the study treatment period as described in the protocol.
- Any concurrent medical condition that, in the judgment of the principal investigator, might interfere with the conduct of the study, confound the interpretation of the study results, or endanger the participant’s well-being.
- Use of systemic corticosteroids 1 week prior to enrollment and during the study.
- Use of contact lenses 2 weeks prior to the baseline visit and during the study.
- Current or prior history of alcohol or substance abuse.
See the full eligibility criteria
Who can join
- Men or women aged ≥ 18 and ≤ 65 years of age.
- Diagnosis of AKC in both eyes, including the presence or medical history of the following: a. other atopic condition (ie,. atopic dermatitis, periocular eczema, asthma, allergic rhinitis), AND b. chronic allergic blepharoconjunctivitis and/or keratoconjunctivitis;
- Ocular itching of at least 50 as assessed by VAS scale.
- Corneal fluorescein staining assessed by modified Oxford scale of at least grade 1 AND a bulbar conjunctival hyperemia assessed by VBR 10 scale of at least 40 (range 0 to 100) in the same eye.
- A composite symptoms score (CSyS) ≥ 5 (sum of the severity scores graded 0 to 3 for each of the following: itching, tearing, ocular discomfort, photophobia, and mucous discharge score) (CSyS range of 0 to 15).
- If a woman of childbearing potential (WOCBP), must have a negative pregnancy test at both screening and baseline visit, and use an acceptable contraception method as described in the protocol.
- Only participants who satisfy all informed consent requirements will be included in the study; the participant and/or his/her legal representative must have read, signed, and dated the informed consent document before any study-related procedures were performed; the informed consent form signed by participants and/or legal representatives must have been approved by the Institutional Review Board (IRB) for the current study.
- Has the ability and willingness to comply with study procedures.
What rules you out
- Inability to speak and understand the local language sufficiently to understand the nature of the study, to provide written informed consent, and to allow the completion of all study assessments
- Fertile men (ie, not surgically sterilized by vasectomy) unwilling to use an acceptable form of contraception (male condom with spermicidal cream or jelly) during the entire course of and 30 days after the study treatment period as described in the protocol.
- Any concurrent medical condition that, in the judgment of the principal investigator, might interfere with the conduct of the study, confound the interpretation of the study results, or endanger the participant’s well-being.
- Use of systemic corticosteroids 1 week prior to enrollment and during the study.
- Use of contact lenses 2 weeks prior to the baseline visit and during the study.
- Current or prior history of alcohol or substance abuse.
- Any prior ocular surgery (including cryosurgery or surgical excision of giant papillae) within 6 months before the screening visit in either eye.
- Participation in a clinical trial with a medical devices within 60 days or with an investigational drug administered within 60 days of screening or within 5 half-lives of the study drug, whichever is longer.
- Participation in any previous clinical study evaluating DFL24498.
- Participation in another clinical trial study at the same time as the present study.
- Evidence of an active ocular infection in either eye
- Intraocular inflammation defined as anterior chamber flare > 0 by Standardization of Uveitis Nomenclature (SUN) grading, in either eye.
- Known or suspected ocular malignancy (ocular surface, intraocular, ocular adnexa)
- Presence of cancer or any other systemic or unstable disease that may affect the ability to participate in the clinical study in the opinion of the investigator including basal cell carcinoma
- Participants that are anatomically monocular.
- Systemic disease not stabilized within 1 month before the screening visit (eg, diabetes with glycemia out of range, thyroid malfunction) or judged by the investigator to be incompatible with the study (eg, current systemic infections) or with a condition incompatible with the frequent assessment required by the study
- History of a serious adverse reaction or significant hypersensitivity to any drug or chemically related compounds to the study product or a clinically significant allergy to drugs, foods, amide local anesthetics or other materials and drugs used in this study
- Females of childbearing potential (ie, not surgically sterilized or post-menopausal for at least 1 year) are excluded from participation in the study if they meet any one of the conditions listed in the protocol
The study team makes the final eligibility decision.
Where it's taking place
- United States
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.
Where is this trial taking place?
Study sites include United States. Enter your location above to see the nearest site and check your eligibility.
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.