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

NCT07264517 | Recruiting Phase 2 DMC FDA Drug

• 1 other identifier: GC2302
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 10

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.

Conditions

Dry Eye Disease

Keywords

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

Outcome Measures

Primary Outcomes (1)

• Number and proportion of participants with treatment-emergent AEs (TEAEs), serious TEAEs, and TEAEs leading to discontinuation.

  Up to Day 84

Study Arms (2)

Group A: GRF312 5% administered b.i.d. (morning/evening)

EXPERIMENTAL

Drug: GRF312 5%

Group B: Vehicle administered b.i.d. (morning/evening)

PLACEBO COMPARATOR

Other: Placebo Comparator

Interventions

GRF312 5% DRUG

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

Group A: GRF312 5% administered b.i.d. (morning/evening)

Placebo Comparator OTHER

Vehicle.

Group B: Vehicle administered b.i.d. (morning/evening)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• \. 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.

You may not qualify if:

• \. 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.
• \. 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).
• Has a known hypersensitivity or contraindication to the study drug(s) or their components.
• In the opinion of the Investigator, be unwilling or unable to comply with the study protocol or unable to successfully self-administer eye drops.
• Use of any IP or device within 30 days prior to start of the Screening or during the study period.
• Any ocular condition that, in the opinion of the Investigator, could affect study parameters including, but not limited to, eyelid margin disorders (e.g., significant blepharitis including staphylococcal, demodex or seborrheic; severe meibomian gland disease, excessive lid laxity, floppy eyelid syndrome, ectropion or entropion), advanced conjuctivochalasis, Salzmann's nodular degeneration, iritis, uveitis, and/or active ocular infection.
• Participants with DED secondary to scarring (such as that seen with irradiation, alkali burns, Steven-Johnson syndrome, cicatricial pemphigoid) or destruction of conjunctival goblet cells (as with Vitamin A deficiency) are not eligible for the study. Participants with incidental scars secondary to refractive surgery (i.e., LASIK surgery) that, in the opinion of the Investigator, will not interfere with study compliance and/or outcome measures are not excluded from the study.
• Known history of alcohol and/or drug abuse within the past 12 months, that in the opinion of the Investigator, may interfere with study compliance, outcome measures including safety parameters, and/or general medical condition of the participant.
• History of active herpes simplex or zoster keratitis in either eye.
• History of neurotrophic keratitis or suspected history of neurotrophic keratitis in the clinical judgement of the Investigator (e.g., abnormal Cochet-Bonnet test).
• Intraocular pressure (IOP) \> 22 mmHg at the Screening Visit.
• Use of below listed medications and/or procedures within the appropriate pre-study period and throughout the study:
• a. Prohibited during the Screening Visit and throughout the study: i. Artificial tear substitutes ii. Current use of eye drops for glaucoma b. Prohibited 7 days prior to the Screening Visit and throughout the study: i. Contact Lenses c. Prohibited 14 days prior to the Screening Visit and throughout the study: i. Topical ocular or systemic antibiotics ii. Serum tears iii. Topical ocular non-steroidal anti-inflammatory drugs (NSAIDS) iv. Topical ocular or oral antihistamines or mast cell stabilizers v. Topical ocular or nasal vasoconstrictors. Phenylephrine to dilate is allowed.

Sponsors & Collaborators

• Instituto Grifols, S.A.: lead

Study Sites (10)

GC2302 Study Site 110

Glendale, California, 91204, United States

RECRUITING

GC2302 Study Site 109

Grove, California, 92843, United States

NOT YET RECRUITING

GC2302 Study Site 103

Newport Beach, California, 92663, United States

RECRUITING

GC2302 Study Site 105

Morrow, Georgia, 30260, United States

RECRUITING

GC2302 Study Site 106

Carmel, Indiana, 46290, United States

RECRUITING

GC2302 Study Site 104

Asheville, North Carolina, 28803, United States

RECRUITING

GC2302 Study Site 101

Garner, North Carolina, 27529, United States

RECRUITING

GC2302 Study Site 107

Cranberry Township, Pennsylvania, 160166, United States

RECRUITING

GC2302 Study Site 102

Memphis, Tennessee, 38119, United States

RECRUITING

GC2302 Study Site 111

San Antonio, Texas, 78229, United States

RECRUITING

MeSH Terms

Conditions

Dry Eye Syndromes; Autoimmune Diseases

Condition Hierarchy (Ancestors)

Lacrimal Apparatus Diseases; Eye Diseases; Immune System Diseases

Central Study Contacts

Chetana Trivedi

CONTACT

919 491 6722; chetana.trivedi@grifols.com

Jerry Kinard

CONTACT

984 385 6555; jerry.kinard@external.grifols.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 24, 2025
• First Posted: December 4, 2025
• Study Start: November 3, 2025
• Primary Completion (Estimated): June 15, 2026
• Study Completion (Estimated): November 14, 2026
• Last Updated: February 13, 2026

Record last verified: 2026-02

Locations

US (10)