A Phase 3 interventional study of DFL24498 and Vehicle in Atopic Keratoconjunctivitis, sponsored by Dompé Farmaceutici S.p.A. Recruiting at 19 sites in 3 countries. Open to participants aged 10 Years to 65 Years. Per ClinicalTrials.gov, last updated 2026-09-21.
Sponsored by Dompé Farmaceutici S.p.A · Phase 3, Interventional, and Treatment
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. The study consists of 2 cohorts: the adult cohort includes approximately 138 participants and the pediatric cohort which includes approximately 15 participants. The cohorts will be randomized separately. Adult participants will be randomized in a 1:1 ratio, while pediatric participants will be randomized in a 2:1 ratio to receive DFL24498 or vehicle.
The study will consist of 3 periods:
714 studies on the registry are indexed under Bronchiolitis Obliterans Syndrome; 128 are open to participants now.
This study's planned enrollment of 153 is above the median of 50 across 565 interventional studies indexed under Bronchiolitis Obliterans Syndrome.
Browse Bronchiolitis Obliterans Syndrome studies →Dompé Farmaceutici S.p.A is the lead sponsor of 52 studies on the registry; 4 are open to participants now.
Of its 18 completed or terminated interventional studies of FDA-regulated products, 18 (100%) have results posted.
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Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Participants are eligible to be included in the study only if all of the following criteria apply:
Diagnosis of AKC in both eyes, including the presence or medical history of the following:
Exclusion Criteria:
Participants will be excluded if any of the following criteria apply:
Note: Additional protocol defined Inclusion/Exclusion criteria apply
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Childbearing potential
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraception
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Cancer (malignancy)
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Participants will be administered with DFL24498 eye drops in both eyes.
Drug: DFL24498 · Drug: dexamethasone sodium phosphate (DSP) ophthalmic solution
Participants will be administered with vehicle eye drops in both eyes.
Drug: Vehicle · Drug: dexamethasone sodium phosphate (DSP) ophthalmic solution
DFL24498 will be instilled in each eye for 12 Weeks.
Vehicle eye drops without active drug will be instilled in each eye for 12 Weeks.
Rescue medication may be administered as required at the Investigator discretion.
Change from baseline at week 6 in ocular itching score assessed by visual analog scale (VAS).
The ocular itching VAS ranges from 0 to 100 mm (0 mm = no ocular itching at all, 100 mm = intolerable itching). Participants will be asked to subjectively rate the current severity of ocular itching at each time point.
Time frame: Baseline and at Week 6
Change from baseline at week 6 in corneal epithelial fluorescein staining, scored by modified Oxford scale, in the study eye.
Fluorescein will be applied to the inferior fornix of the palpebral conjunctiva of each eye. To avoid the phenomenon of quenching, staining will be assessed within 1 to 4 minutes from fluorescein instillation. Examination will be performed at the slit-lamp using blue (cobalt) light. Corneal fluorescein staining will be graded according to the modified Oxford scale (7-point scale: 0, 0.5. 1, 2, 3, 4, 5).
Time frame: Baseline and at Week 6
Change from baseline at week 6 in bulbar conjunctival hyperemia assessed by Validated Bulbar Redness (VBR) 10 scale (0 to 100), in the study eye.
Bulbar conjunctival redness will be assessed at the slit-lamp examination using white light prior to vital dye instillation and graded according to the VBR 10 scale.
Time frame: Baseline and at Week 6
Change from baseline over time in ocular itching score assessed by VAS.
The ocular itching VAS ranges from 0 to 100 mm (0 mm = no ocular itching at all, 100 mm = intolerable itching). Participants will be asked to subjectively rate the current severity of ocular itching at each time point.
Time frame: Baseline and at Week 4, Week 6, Week 8, Week 12, and Week 16
Change from baseline over time in ocular symptoms of itching, tearing, discomfort, mucous discharge, and photophobia on a 4-point scale (0 to 3).
Ocular symptoms are assessed using a 4-point severity scale ranging from 0 (none) to 3 (severe). Five ocular symptoms, itching, tearing, ocular discomfort (including burning, stinging, and foreign body sensation), mucous discharge, and photophobia are evaluated in the study eye. A composite symptom score is described in calculated at screening and Baseline by summing the individual symptom scores, resulting in a total score range of 0 to 15, with higher scores indicating greater symptom severity.
Time frame: Baseline and at Week 4, Week 6, Week 8, Week 12, and Week 16
Change from baseline over time in corneal fluorescein staining (modified Oxford scale) in the study eye.
Corneal fluorescein staining modified Oxford scale (0-5) as per corneal dot count in each eye.
Time frame: Baseline and at Week 4, Week 6, Week 8, Week 12, and Week 16
Change from baseline over time in bulbar conjunctival hyperemia assessed by VBR 10 scale (0 to 100) in the study eye.
Bulbar conjunctival hyperemia assessed by Validated Bulbar Redness (VBR) 10 scale (0 to 100).
Time frame: Baseline and at Week 4, Week 6, Week 8, Week 12, and Week 16
Change from baseline over time in signs of tarsal papillary reaction, corneal neovascularization, cicatrizing conjunctivitis and blepharitis on a 4-point scale (0 to 3) in the study eye.
Change in signs on a 4-point scale (0 to 3) in the study eye.
Time frame: Baseline and at Week 4, Week 6, Week 8, Week 12, and Week 16
Change from baseline at week 6 and 12 in the QoL scores assessed by the Standardized Rhinoconjunctivitis Quality of Life Questionnaire (RQLQ-S) (assessed in the adult cohort only)
Standardized Rhinoconjunctivitis QoL Questionnaire (RQLQ\[S\]) is a validated questionnaire that assesses QoL specifically in patients with rhinoconjunctivitis. There are 28 questions, which are categorized under 7 domains (activities, sleep, non-nose/eye symptoms, practical problems, nasal symptoms, eye symptoms, and emotional). Each question is scored on a 7-point scale from no impairment (score 0) to severe impairment (score 6).
Time frame: Baseline and at Week 6 and Week 12.
Patient Global Impression of Change (PGIC) at week 6 and week 12 (assessed in the adult cohort only)
PGIC is a short questionnaire used to assess how a participant perceives changes in their condition following treatment, on a scale ranging from 1 to 7.
Time frame: At week 6 and week 12.
Number of Participants receiving rescue medication over time after week 6
Participants who received rescued medication over time after week 6 (visit 4).
Time frame: Week 6 to Week 12
Number of participants with treatment-emergent adverse events and serious adverse events (SAEs)
Any adverse events occurring or worsening after the first administration of investigational product is classified as "treatment-emergent" adverse events and does not necessarily have a causal relationship with the intervention. A SAE is any untoward medical occurrence that at any dose results in death, is life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect, is a suspected transmission of any infectious agent via a medicinal product, and is medically important.
Time frame: Up to Week 16
Change from baseline over time in best corrected distance visual acuity (BCDVA) in each eye.
Best corrected visual acuity (BCDVA) is determined by careful refraction according to the standard protocol for refraction. BCDVA is measured by Early Treatment of Diabetic Retinopathy Study chart.
Time frame: Baseline and at Week 4, Week 6, Week 8, Week 12, and Week 16
Change from baseline at week 12 in corneal endothelial cell density in each eye (only at selected sites that have the required equipment).
Corneal central region endothelial cell density will be determined for each eye using specular microscopy and expressed as the number of cells/mm2 using the Cell Density readout provided by the software.
Time frame: Baseline and at week 12
Change from baseline at week 12 in dilated fundus exam in each eye
After specular microscopy, mydriatic drops will be instilled in both eyes and once adequate dilation is achieved, a fundal exam shall be performed to examine the vitreous, retina, and optic nerve.
Time frame: Baseline and at week 12
Change from baseline over time in intraocular pressure in each eye.
IOP will be assessed by tonometry for each eye and will be measured in mmHg.
Time frame: Baseline and at Week 6 and Week 12
Number of participants discontinued due to tolerability during the treatment period
Treatment discontinuation rate due to tolerability.
Time frame: Baseline to week 12
Plan to share: No
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Bronchiolitis Obliterans Syndrome →