SI-614 for Dry Eye
(SIDE Trial)
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial tests a new eye drop called SI-614 to determine its effectiveness and safety for people with dry eye. It compares SI-614 to a placebo (a substance with no active treatment) to assess its benefits. Suitable participants have experienced dry eye in both eyes for at least six months and have tried or wanted to try artificial tears. Participants should not have other eye conditions, such as infections or inflammation, that require treatment. As a Phase 3 trial, this study represents the final step before FDA approval, providing participants an opportunity to contribute to the potential availability of a new treatment for dry eye.
Will I have to stop taking my current medications?
The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the study team or your doctor.
Is there any evidence suggesting that SI-614 ophthalmic solution is likely to be safe for humans?
Research shows that SI-614, the treatment under study for dry eye, has undergone safety testing in people before. Earlier studies suggest that this treatment is generally well-tolerated, with most people not experiencing major side effects.
The current trial's later stage indicates that SI-614 has already demonstrated a good safety record in previous research. This suggests it is likely safe for use, with only mild or moderate side effects, if any. However, as with any treatment, a small chance of side effects exists. Participants should report any unusual symptoms to the study team immediately.12345Why do researchers think this study treatment might be promising?
Unlike the standard treatments for dry eye, which often include artificial tears and anti-inflammatory medications, SI-614 Ophthalmic Solution is designed with a novel mechanism that directly targets the eye surface to enhance lubrication and protect the ocular surface. This treatment utilizes a unique formulation that may offer longer-lasting relief compared to traditional options. Researchers are excited about SI-614 because it has the potential to not only alleviate symptoms more effectively but also improve the overall health of the eye surface, providing a more comprehensive solution for those suffering from dry eye.
What evidence suggests that SI-614 might be an effective treatment for dry eye?
Studies have shown that SI-614, which participants in this trial may receive, is designed to help people with dry eyes by stabilizing the tear film and aiding eye healing. Research indicates that it connects with fibronectin, a protein important for eye health, to reduce dryness and irritation. Specifically, previous patients in those studies reported improvements when using SI-614 compared to a placebo, suggesting its effectiveness. This treatment focuses on enhancing the eye surface's health, which can help reduce dry eye symptoms.678910
Who Is on the Research Team?
George Ousler
Principal Investigator
ORA, Inc.
Are You a Good Fit for This Trial?
Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive SI-614 ophthalmic solution or placebo
Follow-up
Participants are monitored for safety and effectiveness after treatment
What Are the Treatments Tested in This Trial?
Interventions
- SI-614
- Vehicle
Find a Clinic Near You
Who Is Running the Clinical Trial?
Seikagaku Corporation
Lead Sponsor
Statistics & Data Corporation
Collaborator
Statistics & Data Corporation
Industry Sponsor
ORA, Inc.
Industry Sponsor
Stuart Abelson
ORA, Inc.
Chief Executive Officer since 2007
BSc in Neuroscience from Bates College, MBA from Northwestern University
Dr. Gustavo De Moraes
ORA, Inc.
Chief Medical Officer since 2022
MD, PhD in Ophthalmic Sciences, MPH in Biostatistics