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Daydrop® Triple Action for Allergic Eye Symptoms

NCT07805759 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 49

Last updated 2026-09-04

No results posted yet for this study

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.

Conditions

  • Allergic Conjunctivitis of Both Eyes

Interventions

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.

Sponsors & Collaborators

  • Dr. Goya Análisis, SL.

    collaborator INDUSTRY

  • i+Med S.Coop.

    lead INDUSTRY

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-06-08
Primary Completion
2026-08-28
Completion
2026-09-30

Countries

  • Spain

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07805759 on ClinicalTrials.gov