(3S,6S,9S,12R,15S,18S,21S,24S,30S,33S,34R)-30-ETHYL-34-[(E,2R)-HEX-4-EN-2-YL]-4,7,10,12,15,19,25,28-OCTAMETHYL-33-(METHYLAMINO)-6,9,18,24-TETRAKIS(2-METHYLPROPYL)-3,21-DI(PROPAN-2-YL)-1-OXA-4,7,10,13,16,19,22,25,28,31-DECAZACYCLOTETRATRIACONTANE-2,5,8,11,14,17,20,23,26,29,32-UNDECONE HYDROCHLORIDE for Atopic keratoconjunctivitis

Inclusion criteria

• {"criterion_text":"- Men or women aged ≥ 18 and ≤ 65 years of age.\n- 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;\n- Ocular itching of at least 50 as assessed by VAS scale.\n- 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.\n- 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).\n- 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.\n- 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.\n- Has the ability and willingness to comply with study procedures."}

Exclusion criteria

• {"criterion_text":"- 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\n- 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.\n- 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.\n- Use of systemic corticosteroids 1 week prior to enrollment and during the study.\n- Use of contact lenses 2 weeks prior to the baseline visit and during the study.\n- Current or prior history of alcohol or substance abuse.\n- Any prior ocular surgery (including cryosurgery or surgical excision of giant papillae) within 6 months before the screening visit in either eye.\n- 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.\n- Participation in any previous clinical study evaluating DFL24498.\n- Participation in another clinical trial study at the same time as the present study.\n- Evidence of an active ocular infection in either eye\n- Intraocular inflammation defined as anterior chamber flare > 0 by Standardization of Uveitis Nomenclature (SUN) grading, in either eye.\n- Known or suspected ocular malignancy (ocular surface, intraocular, ocular adnexa)\n- 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\n- Participants that are anatomically monocular.\n- 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\n- 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\n- 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"}

Primary endpoints

• {"endpoint_text":"- Change from baseline at week 6 in ocular itching score assessed by visual analog scale (VAS).","definition_or_measurement_approach":"Change from baseline at week 6; ocular itching score assessed by visual analog scale (VAS)."}

Secondary endpoints

• {"endpoint_text":"- Change from baseline at week 6 in corneal epithelial fluorescein staining, scored by modified Oxford scale, in the study eye","definition_or_measurement_approach":"Change from baseline at week 6; corneal epithelial fluorescein staining scored by modified Oxford scale in the study eye."}
• {"endpoint_text":"- 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.","definition_or_measurement_approach":"Change from baseline at week 6; bulbar conjunctival hyperemia assessed by Validated Bulbar Redness (VBR) 10 scale (0 to 100) in the study eye."}

Italy

Earliest CTIS Part Ii Submission Date

10-10-2025

Latest Decision Or Authorization Date

12-11-2025

Processing Time Days

33

Number Of Sites

6

Number Of Participants

69

Spain

Earliest CTIS Part Ii Submission Date

30-10-2025

Latest Decision Or Authorization Date

17-11-2025

Processing Time Days

18

Number Of Sites

5

Number Of Participants

35

Primary sponsor

Full Name

Dompe' Farmaceutici S.p.A.

Organisation Type

Pharmaceutical company

Country Of Registered Address

Italy

Contract research organisations

Name

Parexel International (IRL) Limited

Responsibilities

Sponsor duties codes: 1,10,11,12,2,5,8; contact Clinicaltrial.Enquiries@parexel.com

Name

Merit CRO Inc.

Responsibilities

Best Corrective Visual Acuity Certification; contact info@meritcro.com

Name

Maxer Consulting S.r.l. In Breve Maxer S.r.l.

Responsibilities

Protocol and synopsis redaction; contact massimo.zaninelli@maxerconsulting.com

Third parties

• {"country":"United States","full_name":"Medidata Solutions Inc.","duties_or_roles":"[{\"id\":512457,\"sponsorDuties\":[{\"id\":799551,\"code\":\"7\"}],\"phoneNumber\":\"+12129181800\",\"email\":\"helpdesk@mdsol.com\"}]","organisation_type":"Non-Pharmaceutical company"}
• {"country":"Ireland","full_name":"Parexel International (IRL) Limited","duties_or_roles":"[{\"id\":512460,\"sponsorDuties\":[{\"id\":799554,\"code\":\"1\"},{\"id\":799555,\"code\":\"10\"},{\"id\":799556,\"code\":\"11\"},{\"id\":799557,\"code\":\"12\"},{\"id\":799558,\"code\":\"2\"},{\"id\":799559,\"code\":\"5\"},{\"id\":799560,\"code\":\"8\"}],\"phoneNumber\":\"+35314739500\",\"email\":\"Clinicaltrial.Enquiries@parexel.com\"}]","organisation_type":"Pharmaceutical company"}
• {"country":"Italy","full_name":"Maxer Consulting S.r.l. In Breve Maxer S.r.l.","duties_or_roles":"[{\"id\":512459,\"sponsorDuties\":[{\"id\":799553,\"code\":\"15\",\"value\":\"Protocol and synopsis redaction\"}],\"phoneNumber\":\"+3928342116\",\"email\":\"massimo.zaninelli@maxerconsulting.com\"}]","organisation_type":"Pharmaceutical company"}
• {"country":"Belgium","full_name":"CluePoints","duties_or_roles":"[{\"id\":512458,\"sponsorDuties\":[{\"id\":799552,\"code\":\"15\",\"value\":\"Centralized data monitoring platform\"}],\"phoneNumber\":\"003210778910\",\"email\":\"helpdesk@cluepoints.com\"}]","organisation_type":"Pharmaceutical company"}
• {"country":"United States","full_name":"Merit CRO Inc.","duties_or_roles":"[{\"id\":512456,\"sponsorDuties\":[{\"id\":799550,\"code\":\"15\",\"value\":\"Best Corrective Visual Acuity Certification\"}],\"phoneNumber\":\"+16082848810\",\"email\":\"info@meritcro.com\"}]","organisation_type":"Pharmaceutical company"}