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)

Overview

Sponsor-declared trial summary

Key facts

Sponsor

Dompe' Farmaceutici S.p.A.

Participant type

Patients

Age range

18-64 years, 65+ years

Gender

Male and Female

Therapeutic area

Diseases [C] - Eye Diseases [C11]

Trial duration

27 Nov 2025 → ongoing

Decision date (initial)

2025-11-12

Transition trial

No

Low-intervention

No

Rare-disease indication

No

Vulnerable population

Yes

Funding sources

Dompé Farmaceutici S.p.A.

Trial design

CTIS Part I — objectives, methods, condition coding

Main objective

Scope: Efficacy, Safety, Others

To confirm the efficacy of DFL24498 ophthalmic solution in improving the symptom of ocular itching in participants with AKC after 6 weeks of treatment.

Secondary objectives 2

1. To confirm the efficacy of DFL24498 ophthalmic solution in improving corneal epithelial damage in participants with AKC after 6 weeks of treatment.
2. To confirm the efficacy of DFL24498 ophthalmic solution in improving bulbar conjunctival hyperemia after 6 weeks of treatment

Conditions and MedDRA coding

Atopic Keratoconjunctivitis

Regulatory references

Scientific advice from competent authorities

Food And Drug Administration

Plan to share IPD

No

Eligibility criteria

Principal inclusion / exclusion criteria as submitted by sponsor

Inclusion criteria 8

1. Men or women aged ≥ 18 and ≤ 65 years of age.
2. 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;
3. Ocular itching of at least 50 as assessed by VAS scale.
4. 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.
5. 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).
6. 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.
7. 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.
8. Has the ability and willingness to comply with study procedures.

Exclusion criteria 18

1. 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
2. Evidence of an active ocular infection in either eye
3. Intraocular inflammation defined as anterior chamber flare > 0 by Standardization of Uveitis Nomenclature (SUN) grading, in either eye.
4. Known or suspected ocular malignancy (ocular surface, intraocular, ocular adnexa)
5. 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
6. Participants that are anatomically monocular.
7. 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
8. 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
9. 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
10. 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.
11. 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.
12. Use of systemic corticosteroids 1 week prior to enrollment and during the study.
13. Use of contact lenses 2 weeks prior to the baseline visit and during the study.
14. Current or prior history of alcohol or substance abuse.
15. Any prior ocular surgery (including cryosurgery or surgical excision of giant papillae) within 6 months before the screening visit in either eye.
16. 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.
17. Participation in any previous clinical study evaluating DFL24498.
18. Participation in another clinical trial study at the same time as the present study.

Endpoints

Primary and secondary outcome measures (English text)

Primary endpoints 1

1. Change from baseline at week 6 in ocular itching score assessed by visual analog scale (VAS).

Secondary endpoints 2

1. Change from baseline at week 6 in corneal epithelial fluorescein staining, scored by modified Oxford scale, in the study eye
2. 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.

Investigational products

Investigational medicinal products (IMPs), comparators, placebo, auxiliary

Test 1

Placebo 1

Auxiliary 1

Sponsors and contacts

Sponsor organisations, regulatory contacts, third parties

Dompe' Farmaceutici S.p.A.

Sponsor organisation

Dompe' Farmaceutici S.p.A.

Address

Via Santa Lucia 6

City

Milan

Postcode

20122

Country

Italy

Scientific contact point

Organisation

Dompe' Farmaceutici S.p.A.

Contact name

Dompé Medical Expert

Public contact point

Organisation

Dompe' Farmaceutici S.p.A.

Contact name

Dompé ServiceDesk

Third parties 5

Locations

2 EU/EEA countries · 11 investigational sites

By country

Investigational sites

Country notifications

Trial-start, recruitment-start, end and early-termination notifications submitted per Member State

Results and documents

Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial

Documents 36 files

Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.

Application history

1 submissions — initial application plus substantial / non-substantial modifications