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

Completed

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT07264517

Enrollment

103

Registered

2025-12-04

Start date

2025-11-03

Completion date

2026-05-20

Last updated

2026-06-16

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Dry Eye Disease

Keywords

Phase 2, artificial tear product, primary or secondary Sjogren's syndrome, autoimmune diseases, moderate to severe dry eye disease

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.

Interventions

DRUGGRF312 5%

Immune Globulin (Human), (GRF312 5% Ophthalmic Solution

OTHERPlacebo Comparator

Vehicle.

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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), using corrective lenses (spectacles) if necessary, in O.U. of + 0.7 or better as assessed by Early Treatment of Diabetic Retinopathy Study (ETDRS) chart. A participant must meet all the following inclusion criteria at both Screening and Randomization (Day 1) in the same eye to be eligible for participation in this study: 9\. Have moderate to severe DED in at least one eye, as defined by meeting ALL the following criteria in the same eye: * Unanesthetized STT score of \> 1 and ≤ 7 mm over five minutes. * Total corneal fluorescein staining score of ≥ 4 \[0 to 15 National Eye Institute scale\] 10. Have symptom severity score of ≥ 60 for Eye Discomfort on the Individual Symptom Severity Assessment VAS (0 to 100) at Screening and a Symptom Severity Score of ≥ 50 for Eye Discomfort on the Individual Symptom Severity Assessment VAS (0 to 100) at Randomization (Day 1).

Design outcomes

Primary

Measure	Time frame
Number and proportion of participants with treatment-emergent AEs (TEAEs), serious TEAEs, and TEAEs leading to discontinuation.	Up to Day 84

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Jun 17, 2026