GRF312 5% for Dry Eye Syndrome
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial tests a new eye drop, GRF312 5%, to determine its effectiveness for dry eye syndrome. The main goal is to assess the safety and efficacy of this treatment compared to a placebo (a treatment with no active medicine). It targets individuals with moderate to severe dry eye in at least one eye, who frequently use over-the-counter eye drops, and can self-administer the study eye drops. Participants should not use certain other eye medications or have specific eye conditions that could affect the study outcomes. As a Phase 2 trial, this research focuses on evaluating the treatment's effectiveness in an initial, smaller group of people.
Will I have to stop taking my current medications?
Yes, you may need to stop certain medications. The trial prohibits the use of specific eye drops, antibiotics, antihistamines, and other treatments before and during the study. It's best to discuss your current medications with the study team to see if any need to be paused.
Is there any evidence suggesting that GRF312 5% is likely to be safe for humans?
Research has shown that GRF312 5% is under study for safety in treating dry eye syndrome. Although detailed safety information from earlier studies isn't available, the trial remains in its early stages, suggesting initial tests have shown some safety. The FDA has approved GRF312 5% for testing in this trial, indicating it is considered safe enough for human study. However, ongoing research will provide more information to confirm its safety.12345
Why do researchers think this study treatment might be promising for dry eye syndrome?
Most treatments for dry eye syndrome, like artificial tears and anti-inflammatory eye drops, mainly focus on providing temporary relief or reducing inflammation. But GRF312 5% is unique because it targets the underlying cause of dry eye by enhancing tear production through a novel mechanism. Researchers are excited about GRF312 because it offers the potential for more sustained relief by addressing the root cause rather than just the symptoms. If successful, this could mean longer-lasting comfort for those suffering from dry eye syndrome.
What evidence suggests that GRF312 5% might be an effective treatment for dry eye syndrome?
Research has shown that GRF312 5% eye drops, which participants in this trial may receive, may help treat dry eye syndrome. In an earlier study, people who used these eye drops twice a day for eight weeks noticed significant improvement in their symptoms. The drops might work by calming the immune system in the eyes, reducing inflammation, and helping tears remain stable. Although more research is needed to confirm these results, the early findings are promising for those with dry eye syndrome.23678
Are You a Good Fit for This Trial?
This trial is for adults with Dry Eye Disease (DED). Specific eligibility details are not provided, but typically participants must meet certain health criteria and not have conditions or be taking medications that could interfere with the study.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive GRF312 5% or vehicle placebo administered b.i.d. (morning/evening)
Follow-up
Participants are monitored for safety and effectiveness after treatment
What Are the Treatments Tested in This Trial?
Interventions
- GRF312 5%
Trial Overview
The trial is testing GRF312 5%, a potential treatment for DED, against a placebo. It's in Phase 2, which means it's looking at how safe and effective the treatment is. Participants are randomly chosen to receive either GRF312 or a placebo without knowing which one they get.
How Is the Trial Designed?
2
Treatment groups
Experimental Treatment
Placebo Group
Find a Clinic Near You
Who Is Running the Clinical Trial?
Instituto Grifols, S.A.
Lead Sponsor
Citations
Grifols receives FDA clearance of IND application for ...
Results showed that when treated with eye drops based on a Grifols IG product twice daily for eight weeks, patients achieved a significant ...
FDA clears Grifols' application for dry eye disease treatment
The US FDA has cleared Grifols' investigational new drug (IND) application to commence a Phase II trial of GRF312 Ophthalmic Solution.
Effects of Dry Eye Treatments on the Ocular Surface
This study evaluated the effects of the corticosteroid dexamethasone on suppressing development of eye irritation, cornea epithelial disease and increased ...
Quintessence of currently approved and upcoming ...
The aim of this review is to present the details of currently approved and upcoming treatment options for DED in a nutshell.
Ophthalmics, Anti-Inflammatory/Immunomodulator ...
Dry eye disease (DED), also known as dry eye syndrome and keratoconjunctivitis sicca, is related to either decreased tear volume (aqueous deficient dry eyes) ...
Evaluating the Safety, Tolerability, and Efficacy of GRF312 ...
Evaluating the Safety, Tolerability, and Efficacy of GRF312 5% in Participants With Dry Eye Disease (DED). ClinicalTrials.gov ID NCT07264517.
FDA Clears Immunoglobulin Eye Drops for Phase II Dry Eye ...
GRF312 Ophthalmic Solution, Selagine's investigational therapy, is designed to address the complex immunopathology of chronic dry eye disease ...
FDA Grants IND Clearance for Immunoglobulin Eye Drops ...
The US Food and Drug Administration (FDA) has granted Investigational New Drug (IND) clearance for immunoglobulin (IG) drops (GRF312 Ophthalmic Solution)
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