Actively Recruiting
A Phase 2, Double-masked, Randomized, Vehicle-controlled Study Evaluating the Safety, Tolerability, and Efficacy of GRF312 5% in Participants With Dry Eye Disease
Led by Instituto Grifols, S.A. · Updated on 2026-02-13
100
Participants Needed
10
Research Sites
21 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the safety, tolerability, and effectiveness of GRF312 5% ophthalmic solution in adults with moderate to severe Dry Eye Disease (DED). This Phase 2 study is randomized, double-masked, and vehicle-controlled, aiming to better understand how this treatment impacts participants experiencing DED symptoms. The trial is sponsored by Instituto Grifols, S.A. and includes adult participants willing to follow study procedures closely. Participants will be randomly assigned to receive either GRF312 5% eye drops or a placebo vehicle, both administered twice daily (morning and evening). The study includes a screening period followed by treatment and observation phases lasting up to 84 days. Participants will self-administer eye drops and attend scheduled visits to monitor their progress and any side effects. During the study, participants will undergo assessments including visual acuity tests, symptom severity evaluations, and monitoring for treatment-emergent adverse events. The main outcome measured is the number and proportion of participants experiencing adverse events related to the treatment up to Day 84. Researchers will also assess symptom changes and safety throughout the trial. Participants are expected to comply with treatment and visit schedules for the study duration.
CONDITIONS
Brief Title
Evaluating the Safety, Tolerability, and Efficacy of GRF312 5% in Participants With Dry Eye Disease (DED).
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Adults aged 18 years or older
- Willing and able to self-administer eye drops and attend required study visits
- History of Dry Eye Disease in both eyes
- Use of over-the-counter artificial tears within 30 days before screening
- Participants with certain autoimmune diseases like Sjogren's syndrome may be eligible if stable and not using systemic steroids or drugs affecting study parameters
- Corrected visual acuity of +0.7 or better in both eyes
- Moderate to severe Dry Eye Disease in at least one eye, defined by specific clinical test scores
- Eye discomfort symptom severity scores meeting specified thresholds at screening and randomization
You will not qualify if you...
- Known allergy or contraindication to the study drug or its components
- Unwilling or unable to comply with study protocol or self-administer eye drops
- Use of any investigational product or device within 30 days before screening or during the study
- Ocular conditions affecting study parameters, including certain eyelid disorders, infections, inflammations, or severe eye surface diseases
- Dry Eye Disease caused by scarring or destruction of conjunctival goblet cells, except stable post-refractive surgery scars
- History of alcohol or drug abuse within the past 12 months
- History of active herpes simplex or zoster keratitis or neurotrophic keratitis
- Intraocular pressure above 22 mmHg at screening
- Use of prohibited medications or procedures within specified timeframes before screening and during the study, including artificial tears, glaucoma eye drops, contact lenses, antibiotics, corticosteroids, certain ophthalmic solutions, and ocular surgeries
- Significant chronic illnesses that could interfere with study parameters
- Known infection with Hepatitis B, Hepatitis C, or HIV
- Non-compliance with vehicle regimen during run-in period at randomization
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to 12 weeks (84 days)
Participants receive GRF312 5% or placebo eye drops twice daily to evaluate safety, tolerability, and efficacy for Dry Eye Disease.
Regular visits during treatment period
Trial Site Locations
Total: 10 locations
1
GC2302 Study Site 110
Glendale, California, United States, 91204
Actively Recruiting
2
GC2302 Study Site 109
Grove, California, United States, 92843
Not Yet Recruiting
3
GC2302 Study Site 103
Newport Beach, California, United States, 92663
Actively Recruiting
4
GC2302 Study Site 105
Morrow, Georgia, United States, 30260
Actively Recruiting
5
GC2302 Study Site 106
Carmel, Indiana, United States, 46290
Actively Recruiting
6
GC2302 Study Site 104
Asheville, North Carolina, United States, 28803
Actively Recruiting
7
GC2302 Study Site 101
Garner, North Carolina, United States, 27529
Actively Recruiting
8
GC2302 Study Site 107
Cranberry Township, Pennsylvania, United States, 160166
Actively Recruiting
9
GC2302 Study Site 102
Memphis, Tennessee, United States, 38119
Actively Recruiting
10
GC2302 Study Site 111
San Antonio, Texas, United States, 78229
Actively Recruiting
Research Team
C
Chetana Trivedi
J
Jerry Kinard
How is the study designed?
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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