Actively Recruiting
Evaluating the Safety, Tolerability, and Efficacy of GRF312 5% in Participants With Dry Eye Disease (DED).
Led by Instituto Grifols, S.A. · Updated on 2026-02-13
100
Participants Needed
10
Research Sites
53 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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
Official 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 all study visits
- History of dry eye disease in both eyes
- Use of over-the-counter artificial tears within 30 days before screening
- May have Sjogren's syndrome or other autoimmune diseases if stable and not on steroids
- 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 scores
- Symptom severity scores for eye discomfort meeting study thresholds at screening and randomization
You will not qualify if you...
- Known allergy or contraindication to study drug or its components
- Unable or unwilling to follow study protocol or self-administer eye drops
- Use of investigational products or devices within 30 days before screening or during study
- Ocular conditions affecting study results such as severe eyelid disorders or active infections
- Dry eye disease caused by scarring or destruction of conjunctival cells, except stable post-refractive surgery
- History of alcohol or drug abuse in past 12 months affecting compliance
- History of active herpes keratitis or neurotrophic keratitis
- Intraocular pressure above 22 mmHg at screening
- Use of prohibited eye medications or procedures within specified timeframes before and during study
- Significant chronic illnesses interfering with study participation
- Known infection with Hepatitis B, Hepatitis C, or HIV
- Non-compliance with treatment regimen during run-in period
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
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
CONTACT
J
Jerry Kinard
CONTACT
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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