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Recruiting Phase 2 NCT07264517

Evaluating the Safety, Tolerability, and Efficacy of GRF312 5% in Participants With Dry Eye Disease (DED).

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Trial Parameters

Condition Dry Eye Disease
Sponsor Instituto Grifols, S.A.
Study Type INTERVENTIONAL
Phase Phase 2
Enrollment 100
Sex ALL
Min Age 18 Years
Max Age N/A
Start Date 2025-11-03
Completion 2026-06-15
Interventions
GRF312 5%Placebo Comparator

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Brief Summary

This is a Phase 2, multi-site, double-masked, randomized, vehicle-controlled, study designed to evaluate the safety, tolerability, and efficacy in adult participants with DED.

Eligibility Criteria

Inclusion criteria 3. Participant willing and able to self-administer eye drops, follow instructions during the Run-in Period and Treatment Period, and be present for the required visits for the duration of the study. 4\. Participant-reported history of DED in O.U. 5. History of non-prescription (over-the-counter) artificial tear product use within 30 days prior to start of the Screening. 7\. Participants with primary or secondary Sjogren's syndrome (e.g., rheumatoid arthritis, systemic lupus erythematosuis,) or other autoimmune diseases (e.g., multiple sclerosis, inflammatory bowel disease) are eligible for enrollment consideration provided the participant meets all other inclusion and exclusion criteria, AND, is not in a medical state in the opinion of the Investigator that could interfere with study parameters, is not taking systemic/ocular steroids, and is not receiving systemic drugs to actively manage their baseline medical state. 8\. Have a Current-corrected Visual Acuity (CCVA)

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