Allergic Conjunctivitis of Both Eyes
Conditions
Keywords
Allergic Conjunctivitis, Ophthalmic Solution, Hyaluronic acid, Clinical Investigation
Brief summary
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.
Interventions
DEVICEEye Drops, Lubricant
Participants will receive Daydrop® Triple Action ophthalmic drops for allergic conjunctivitis. The study treatment will be administered according to the dosing regimen throughout the study period. Participants will be evaluated for changes in ocular symptoms and signs associated with allergic conjunctivitis, including itching, redness, tearing, and ocular discomfort, as well as for treatment tolerability and safety.
Sponsors
i+Med S.Coop.
Dr. Goya Análisis, SL.
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Ocular Itching Intensity Assessment | Day 0, 7 days and 14 days | 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. |
| Serious Adverse Event (SAE) Recording | Day 0, 7 days and 14 days | — |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Ocular Redness Assessment | Day 0, 7 days and 14 days | 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 symptoms associated with allergic conjunctivitis | Day 0, 24 hours, 7 days and 14 days | 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 | Day 0, 7 days and 14 days | 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 with Tear Break Up Time (TBUT) | Day 0, 7 days and 14 days | 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. |
| Clinical Global Impression of Improvement (CGI-I) | Day 0, 7 days and 14 days | 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 Global Assessment of Improvement and Treatment Satisfaction | 14 days | 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. |
Countries
Spain
Contacts
CONTACTJosune Torrecilla
CONTACTJon Armentia
Outcome results
None listed