An Efficacy and Safety Study of DFL24498 in the Treatment of AKC

Phase 3RecruitingNCT07395232

Dompé Farmaceutici S.p.A138 enrolled

Overview

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.

The study will consist of 3 periods: 1. Screening period (from Day -7 ± 1 to Day 1), 2. Treatment Period (from randomization through Week12) and 3. Follow-up period (Weeks 13 to 16).

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

TRIPLE

Enrollment

138

Conditions

Atopic Keratoconjunctivitis

Interventions

DFL24498DRUG

DFL24498 will be instilled in each eye for 12 Weeks.

VehicleDRUG

Vehicle eye drops without active drug will be instilled in each eye for 12 Weeks.

dexamethasone sodium phosphate (DSP) ophthalmic solutionDRUG

Rescue medication may be administered as required at the Investigator discretion.

Eligibility

Sex: ALLMin age: 18 YearsMax age: 65 Years

Medical Language ↔ Plain English

Inclusion Criteria: Participants are eligible to be included in the study only if all of the following criteria apply: 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: 1. other atopic condition (ie,. atopic dermatitis, periocular eczema, asthma, allergic rhinitis), AND 2. 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. Exclusion Criteria: Participants will be excluded if any of the following criteria apply: 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. Note: Additional protocol defined Inclusion/Exclusion criteria apply

Locations (19)

Bowden Eye Associates - Southside Location

Jacksonville, Florida, United States

Outcomes

Primary Outcomes

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

Secondary Outcomes

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.

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).

Central Contacts

Dompé farmaceutici S.p.A. Via Santa Lucia, 6, 20122 Milan (MI)

CONTACT

+39 02 583 831

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.

University of Miami, Miller School of Medicine, Bascom Palmer Eye Institute

Miami, Florida, United States

NOT_YET_RECRUITING

Clayton Eye Clinical Research

Morrow, Georgia, United States

RECRUITING

Ophthalmology Associates

St Louis, Missouri, United States

RECRUITING

NYU Langone Health - Eye Center

New York, New York, United States

NOT_YET_RECRUITING

Duke Eye Center - Ophthalmology

Durham, North Carolina, United States

NOT_YET_RECRUITING

Total Eye Care, PA

Memphis, Tennessee, United States

RECRUITING

Baylor University Jamail Specialty Care Center- Alkek Eye Center- Ophthalmology

Houston, Texas, United States

NOT_YET_RECRUITING

IRCCS AOU di Bologna - Policlinico Sant'Orsola UO Oftalmologia

Bologna, Italy

NOT_YET_RECRUITING

Ospedale SS Annunziata, ASL 2 Lanciano Vasto Chieti

Chieti, Italy

NOT_YET_RECRUITING

...and 9 more locations

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)

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.

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 (proportion of participants with vitritis, retinal or vitreal hemorrhages, increase in cup-to-disc ratio, retinal or posterior vitreal detachment, retinal tears, or maculopathy).

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 applanation 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