Trials / Recruiting
RecruitingNCT07264517
Evaluating the Safety, Tolerability, and Efficacy of GRF312 5% in Participants With Dry Eye Disease (DED).
A Phase 2, Double-masked, Randomized, Vehicle-controlled Study Evaluating the Safety, Tolerability, and Efficacy of GRF312 5% in Participants With Dry Eye Disease
- Status
- Recruiting
- Phase
- Phase 2
- Study type
- Interventional
- Enrollment
- 100 (estimated)
- Sponsor
- Instituto Grifols, S.A. · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
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
| Type | Name | Description |
|---|---|---|
| DRUG | GRF312 5% | Immune Globulin (Human), (GRF312 5% Ophthalmic Solution |
| OTHER | Placebo Comparator | Vehicle. |
Timeline
- Start date
- 2025-11-03
- Primary completion
- 2026-06-15
- Completion
- 2026-11-14
- First posted
- 2025-12-04
- Last updated
- 2026-02-13
Locations
10 sites across 1 country: United States
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT07264517. Inclusion in this directory is not an endorsement.