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

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.

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).

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.

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.

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.

Corneal fluorescein staining modified Oxford scale (0-5) as per corneal dot count in each eye.

Bulbar conjunctival hyperemia assessed by Validated Bulbar Redness (VBR) 10 scale (0 to 100).

Change in signs on a 4-point scale (0 to 3) in the study eye.

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).

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.

Participants who received rescued medication over time after week 6 (visit 4).

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.

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.

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.

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.

IOP will be assessed by applanation tonometry for each eye and will be measured in mmHg.

Treatment discontinuation rate due to tolerability.