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Tests treatment safety and results for Atopic Keratoconjunctivitis
Official title An Efficacy and Safety Study of DFL24498 in the Treatment of AKC
ClinicalTrials.gov ID: NCT07395232
What this study is testing
What is DFL24498?
DFL24498 is an investigational medicine, being studied as a potential treatment for atopic keratoconjunctivitis.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- This is a phase 3, multicenter, randomized, double-masked, parallel-group, vehicle-controlled study to evaluate the safety and efficacy of DFL24498 compared with vehicle ophthalmic solution, in participants with AKC. Approximately 138 participants who meet all eligibility criteria will be enrolled in the study.
- Phase 3: a large, late-stage study
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 65
You may be able to join if
- Participants are eligible to be included in the study only if all of the following criteria apply:
- 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:
- other atopic condition (ie,. atopic dermatitis, periocular eczema, asthma, allergic rhinitis), AND
- chronic allergic blepharoconjunctivitis and/or keratoconjunctivitis.
You likely can't join if
- Participants will be excluded if any of the following criteria apply:
- Inability to speak and understand the local language sufficiently to understand the nature of the study, to provide written informed consent, and to...
- 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...
See the full eligibility criteria
- Participants are eligible to be included in the study only if all of the following criteria apply:
- 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:
- other atopic condition (ie,. atopic dermatitis, periocular eczema, asthma, allergic rhinitis), AND
- 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.
- Participants will be excluded if any of the following criteria apply:
- 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.
- 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...
The study team makes the final eligibility decision.
Where it's taking place
- Jacksonville, Florida, United States
- Miami, Florida, United States
- Morrow, Georgia, United States
- St Louis, Missouri, United States
- New York, New York, United States
- Durham, North Carolina, United States
- Memphis, Tennessee, United States
- Houston, Texas, United States
- Bologna, Italy
- Chieti, Italy
- Florence, Italy
- Roma, Italy
- Verona, Italy
- Córdoba, Spain
- Santiago de Compostela, Spain
- Valencia, Spain
- Valladolid, Spain
- Zaragoza, Spain
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 years to 65 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Jacksonville, Florida, United States; Miami, Florida, United States; Morrow, Georgia, United States; St Louis, Missouri, United States; New York, New York, United States; Durham, North Carolina, United States and 12 more location(s). 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 ClinicalTrials.gov; the study team decides eligibility.