Daydrop® Triple Action for Allergic Eye Symptoms

i+Med S.Coop.49 enrolled

Overview

The study is designed to evaluate the safety and efficacy of Daydrop® Triple Action for the symptomatic treatment of seasonal or perennial allergic conjunctivitis. It is a prospective, post-market clinical investigation using a quasi-experimental before-and-after design with intra-subject control. Daydrop® Triple Action is an ophthalmic solution containing ectoine, hyaluronic acid, and carboxymethylcellulose, developed to hydrate, lubricate, and protect the ocular surface, helping to relieve symptoms such as itching, redness, tearing, and foreign body sensation. The study will enroll 49 adult patients with active allergic conjunctivitis and will follow them for 14 days, with assessments at baseline, 24 hours, 7 days, and 14 days. Participants will use the product once or twice daily, according to the investigator's judgment. The primary efficacy endpoint is the reduction of ocular itching, while the primary safety endpoint is the incidence of serious adverse events. Secondary assessments include changes in ocular redness, overall ocular symptoms, clinical signs of allergic conjunctivitis, tear film stability (TBUT), patient satisfaction, and global improvement evaluations by both the investigator and the patient. Overall, the study aims to generate clinical evidence demonstrating that Daydrop® Triple Action is a safe and effective non-pharmacological option for improving the signs and symptoms associated with allergic conjunctivitis.

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Allergic Conjunctivitis of Both Eyes

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Adults aged 18 years or older * Active episode of allergic conjunctivitis prior to study initiation, assessed and confirmed by the specialist using a slit-lamp examination. * Score of ≥ 2 points on either the Ora Calibra Ocular Itching Score or the Ocular Redness Score, as assessed by the participant and the investigator, respectively. * Ability to self-administer the study product. * Ability to understand the Patient Information Sheet and provide written informed consent. Exclusion Criteria: * History of hypersensitivity to any component of the study product. * Systemic treatment with antihistamines (e.g., loratadine, cetirizine, desloratadine, ebastine) or corticosteroids (e.g., fluorometholone, loteprednol, dexamethasone), and/or topical treatment with any ophthalmic medication with anti-allergic or anti-inflammatory activity, including antihistamines or mast cell stabilizers (e.g., olopatadine, ketotifen, azelastine) and ophthalmic corticosteroids (e.g., fluorometholone, loteprednol, dexamethasone), except for artificial tears, within the week prior to study initiation. * Clinically significant ocular infection or inflammation. * Other active ocular conditions, including but not limited to glaucoma, Sjögren's syndrome, severe dry eye disease, Stevens-Johnson syndrome, active uveitis or keratitis, severe or chronic blepharitis, and other forms of conjunctivitis of non-allergic origin. * Ocular surgery within the 3 months prior to study entry. * Refractive surgery within the previous 6 months. * Pregnancy or planned breastfeeding.

Outcomes

Primary Outcomes

Ocular Itching Intensity Assessment

Assessment of the change in ocular itching intensity, as reported by the patient, from baseline to the end of the study using an adapted version of the Ora Calibra Ocular Itching Scale. The scale ranges from 0 (no itching) to 4 (incapacitating itching), with 0.5-point increments. Treatment efficacy will be evaluated based on the reduction in itching scores. Both eyes will be assessed separately, and an average score per patient will be calculated. Mean scores for the right eye, left eye, and the overall patient average will be analyzed. The study will also determine the percentage of patients achieving itching scores between 0.0 and 2.0 (from no itching to mild-moderate itching) and the percentage of patients showing an improvement of at least 0.5 points at Days 7 and 14. A reduction of 0.5 points or more from baseline will be considered clinically meaningful.