Evaluating the Safety, Tolerability, and Efficacy of GRF312 5% in Participants With Dry Eye Disease (DED).
NCT07264517 · Status: RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 100
Last updated 2026-02-13
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.
Conditions
Interventions
- DRUG
-
GRF312 5%
Immune Globulin (Human), (GRF312 5% Ophthalmic Solution
- OTHER
-
Placebo Comparator
Vehicle.
Sponsors & Collaborators
-
Instituto Grifols, S.A.
lead INDUSTRY
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- QUADRUPLE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2025-11-03
- Primary Completion
- 2026-06-15
- Completion
- 2026-11-14
- FDA Drug
- Yes
Countries
- United States
Study Locations
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