Daydrop® Triple Action for Allergic Eye Symptoms

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.

Assessment of changes in conjunctival redness, as evaluated by the investigator, from baseline to the end of the study using an adapted version of the Ora Calibra Ocular Redness Scale. The scale ranges from 0 (no redness) to 4 (severe redness), and treatment efficacy will be assessed based on reductions in redness scores.

Both eyes will be evaluated separately, and mean scores will be calculated for each eye as well as overall patient averages. The analysis will determine the percentage of patients with redness scores between 0.0 and 2.0 (no to moderate redness) and the percentage achieving 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.

Assessment of changes in allergic conjunctivitis symptoms, including ocular itching, tearing, perceived ocular redness, and foreign body sensation, as reported by the patient using the Total Ocular Symptom Score (TOSS) questionnaire. The TOSS is a 4-point Likert scale ranging from 0 (absent) to 3 (severe) for each symptom, with a total score ranging from 0 to 12, where higher scores indicate greater symptom severity.

Both eyes will be assessed separately, and an average score per patient will be calculated. The analysis will evaluate the distribution of patients across symptom severity categories at each study visit, as well as the mean change in TOSS scores over time to determine symptom improvement throughout the treatment period.

Assessment of changes in the clinical signs of allergic conjunctivitis by the investigator, including conjunctival hyperemia, chemosis, and conjunctival papillae, using a 4-point Likert scale (absent, mild, moderate, and severe). Both eyes will be evaluated separately, and the mean score of the two eyes will subsequently be calculated for each participant. Improvement in clinical signs will be assessed based on a reduction in the severity score. The percentage of patients in each category at the different assessment time points, as well as the mean improvement observed at each time point, will be calculated and analyzed.

Assessment of tear film stability using the Tear Break-Up Time (TBUT) test, performed by the investigator to measure the time the tear film remains stable before breaking up. Both eyes will be evaluated separately, and an average value per patient will be calculated. An increase in TBUT indicates improved tear film stability and ocular surface condition. Changes from baseline and improvements at each follow-up visit will be analyzed.

Investigator Global Assessment of Improvement will be evaluated using the Clinical Global Impression of Improvement (CGI-I) scale, a 7-point rating scale ranging from "much improved" to "much worse." The investigator will assess the patient's overall clinical evolution from the start of treatment to the end of the study.

The analysis will focus on the proportion of patients showing a positive clinical response, defined as ratings of "much improved," "moderately improved," or "slightly improved."

Patient-reported evaluation of overall improvement and treatment satisfaction at Day 14. Global improvement will be assessed using a 7-point Likert scale ranging from much improved to much worse, while treatment satisfaction will be assessed using a 5-point scale ranging from exceptionally satisfied to not satisfied. The percentage of patients reporting a positive outcome will be calculated, defined as responses of much improved, moderately improved, or slightly improved for global improvement, and exceptionally satisfied, very satisfied, or satisfied for treatment satisfaction.