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

Part of paid clinical trials in Glendale, California.

Sponsor
Instituto Grifols, S.A.
Study ID
NCT07264517
Phase
PHASE2
Status
Recruiting
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Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • GRF312 5% — DRUG
    Immune Globulin (Human), (GRF312 5% Ophthalmic Solution
  • Placebo Comparator — OTHER
    Vehicle.

Study Details

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.

Key Dates

Start date
Nov 3, 2025
Status verified
Feb 2026
Primary completion
Jun 15, 2026
Completion
Nov 14, 2026

Study Design

Enrollment
100 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Group A: GRF312 5% administered b.i.d. (morning/evening)
  • Placebo Comparator: Group B: Vehicle administered b.i.d. (morning/evening)

Primary Outcome Measure

Number and proportion of participants with treatment-emergent AEs (TEAEs), serious TEAEs, and TEAEs leading to discontinuation. [ Time Frame: Up to Day 84 ]

Central Contacts

Locations (10)

FacilityCityStateZIPSite coordinators
GC2302 Study Site 110GlendaleCalifornia91204
Jerry Kinard
[email protected]
GC2302 Study Site 109GroveCalifornia92843
Jerry Kinard
[email protected]
GC2302 Study Site 103Newport BeachCalifornia92663
Jerry Kinard
[email protected]
GC2302 Study Site 105MorrowGeorgia30260
GC2302 Study Site 106CarmelIndiana46290
GC2302 Study Site 104AshevilleNorth Carolina28803
GC2302 Study Site 101GarnerNorth Carolina27529
GC2302 Study Site 107Cranberry TownshipPennsylvania160166
GC2302 Study Site 102MemphisTennessee38119
GC2302 Study Site 111San AntonioTexas78229

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