An interventional study of Eye Drops, Lubricant in Allergic Conjunctivitis of Both Eyes, sponsored by i+Med S.Coop.. Recruiting at 1 site in Spain. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-11-03.
Sponsored by i+Med S.Coop. · Not applicable, Interventional, and Treatment
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.
210 studies on the registry are indexed under Conjunctivitis, Allergic; 18 are open to participants now.
This study's planned enrollment of 49 is below the median of 87 across 174 interventional studies indexed under Conjunctivitis, Allergic.
Browse Conjunctivitis, Allergic studies →i+Med S.Coop. is the lead sponsor of 16 studies on the registry; 5 are open to participants now.
Counted across the registry records on this site, refreshed daily.
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Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hypersensitivity
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Corticosteroids (steroids)
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Clinically significant
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Participants with allergic conjunctivitis treated with Daydrop® Triple Action during the study period to evaluate its effectiveness and safety in relieving ocular allergy symptoms.
Device: Eye 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.
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.
Time frame: Day 0, 7 days and 14 days
Serious Adverse Event (SAE) Recording
Time frame: Day 0, 7 days and 14 days
Ocular Redness Assessment
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.
Time frame: Day 0, 7 days and 14 days
Assessment of changes in symptoms associated with allergic conjunctivitis
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.
Time frame: Day 0, 24 hours, 7 days and 14 days
Assessment of Changes in the Clinical Signs of Allergic Conjunctivitis
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.
Time frame: Day 0, 7 days and 14 days
Assessment of tear film stability with Tear Break Up Time (TBUT)
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.
Time frame: Day 0, 7 days and 14 days
Clinical Global Impression of Improvement (CGI-I)
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."
Time frame: Day 0, 7 days and 14 days
Patient Global Assessment of Improvement and Treatment Satisfaction
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.
Time frame: 14 days
Plan to share: No
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From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
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