A Phase 2, Double-masked, Randomized, Vehicle-controlled Study Evaluating the Safety, Tolerability, and Efficacy of GRF312 5% in Participants With Dry Eye Disease
Instituto Grifols, S.A.
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
- Age range
- 18+ years
- Sex
- All
- Healthy volunteers
- No
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)…
Interventions
- DrugGRF312 5%
Immune Globulin (Human), (GRF312 5% Ophthalmic Solution
- OtherPlacebo Comparator
Vehicle.
Locations (10)
- GC2302 Study Site 110Glendale, California
- GC2302 Study Site 109Grove, California
- GC2302 Study Site 103Newport Beach, California
- GC2302 Study Site 105Morrow, Georgia
- GC2302 Study Site 106Carmel, Indiana
- GC2302 Study Site 104Asheville, North Carolina