Allergic Conjunctivitis of Both EyesNCT07805759
Daydrop® Triple Action for Allergic Eye Symptoms
A study testing Eye Drops, Lubricant in people with Allergic Conjunctivitis of Both Eyes, run by i+Med S.Coop. at 1 site in Spain.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Allergic Conjunctivitis of Both Eyes
- What is being tested?
- Eye Drops, Lubricant
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 49 participants
- Where
- 1 siteSpain
- Study dates
- 8 Jun 2026to 30 Sep 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Spain1 site, 1 recruiting
- Recruiting
Complutense Medical Center (Virtus Group)
Madrid, Madrid, 28805
Montse Ortega, 918 893 600, mortega@goyainnova.com
About this study
Official title: Clinical Investigation of Daydrop® Triple Action for the Symptomatic Treatment of Allergic Conjunctivitis.
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.
Read more
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.
- Conditions
- Allergic Conjunctivitis of Both Eyes
- Being tested
- Eye Drops, Lubricant
- Keywords
- Allergic Conjunctivitis, Ophthalmic Solution, Hyaluronic acid, Clinical Investigation
- Medical subject headings
- Conjunctivitis, Allergic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Eye Drops, LubricantDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| Daydrop® Triple Action | Experimental | Participants with allergic conjunctivitis treated with Daydrop® Triple Action during the study period to evaluate its effectiveness and safety in relieving ocular allergy symptoms. Receives: Device: Eye Drops, Lubricant |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Day 0, 7 days and 14 days
Serious Adverse Event (SAE) Recording
Measured: Day 0, 7 days and 14 days
Secondary outcomes (6)
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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."
Measured: 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.
Measured: 14 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Sep 2026
- Study start8 Jun 2026
- Primary completion28 Aug 2026 (estimated)
- Study completion30 Sep 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Allergic Conjunctivitis of Both EyesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 49 participants (estimated)
Sponsor and investigators
- Lead sponsor
- i+Med S.Coop.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Dr. Goya Análisis, SL.
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07805759
- Sponsor's protocol ID
- Daydrop-PIC01-2026
- Status last verified
- Aug 2026
- First submitted
- 1 Sep 2026
- Last updated
- 4 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Investigation of Daydrop® Triple Action for the Symptomatic Treatment of Allergic Conjunctivitis.
- ClinicalTrials.gov ID
- NCT07805759
- Acronym / sponsor ID
- Daydrop-PIC01-2026
- Conditions
- Allergic Conjunctivitis of Both Eyes
- Keywords
- Allergic Conjunctivitis, Ophthalmic Solution, Hyaluronic acid, Clinical Investigation
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 49 participants (estimated)
- Lead sponsor
- i+Med S.Coop.Industry (pharma, biotech, devices)
- Collaborators
- Dr. Goya Análisis, SL.
- Study start
- 8 Jun 2026 (actual)
- Primary completion
- 28 Aug 2026 (estimated)
- Study completion
- 30 Sep 2026 (estimated)
- First posted
- 4 Sep 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Daydrop® Triple Action | Experimental | Device: Eye Drops, LubricantParticipants with allergic conjunctivitis treated with Daydrop® Triple Action during the study period to evaluate its effectiveness and safety in relieving ocular allergy symptoms. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (7 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Eye Drops, LubricantParticipants 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. | Device | Daydrop® Triple Action |
Primary outcome
Ocular Itching Intensity Assessment
Time frame: 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
Time frame: Day 0, 7 days and 14 days
6 secondary outcomes
Ocular Redness Assessment
Time frame: Day 0, 7 days and 14 days
Assessment of changes in symptoms associated with allergic conjunctivitis
Time frame: Day 0, 24 hours, 7 days and 14 days
Assessment of Changes in the Clinical Signs of Allergic Conjunctivitis
Time frame: Day 0, 7 days and 14 days
Assessment of tear film stability with Tear Break Up Time (TBUT)
Time frame: Day 0, 7 days and 14 days
Clinical Global Impression of Improvement (CGI-I)
Time frame: Day 0, 7 days and 14 days
Patient Global Assessment of Improvement and Treatment Satisfaction
Time frame: 14 days
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Sep 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Eye Drops, Lubricant in people with Allergic Conjunctivitis of Both Eyes, run by i+Med S.Coop. at 1 site in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 4 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Josune Torrecilla (+34945561134, jtorrecilla@imasmed.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Ocular Itching Intensity Assessment (time frame: Day 0, 7 days and 14 days). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Sep 2026.