SUM-191 for Pink Eye

Overseen By Satoshi Yamamoto

Age: 18+

Sex: Any

Trial Phase: Phase 1 & 2

Sponsor: Senju USA, Inc.

Must not be taking: Antibiotics, Anti-inflammatories

Disqualifiers: Infections, Ocular herpes, Glaucoma, others

Compensation: Varies

Number of Visits: Unknown

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to test a new treatment called SUM-191 for bacterial pink eye. Researchers seek to determine if SUM-191 is safe and effective compared to a placebo (a substance with no active medicine). The trial seeks individuals diagnosed with bacterial conjunctivitis in at least one eye. Participants must be willing to stop wearing contact lenses during the trial. This study will help determine if SUM-191 can become a reliable treatment option for bacterial pink eye in the future. As a Phase 1 and Phase 2 trial, the research focuses on understanding how the treatment works in people and measuring its effectiveness in an initial, smaller group.

Do I have to stop taking my current medications for the trial?

The trial requires that you stop using any topical ocular or systemic antibiotics and anti-inflammatory agents within 72 hours before the first dose. If you're taking these types of medications, you will need to stop them before participating.

Is there any evidence suggesting that SUM-191 is likely to be safe for humans?

Research shows that SUM-191 is currently being tested for safety and tolerability. Specific safety data from earlier studies is not yet available. However, the trial's early stage indicates that SUM-191 has shown enough promise in lab or animal studies to warrant testing in humans. This suggests researchers consider it potentially safe for small groups.

Early trials prioritize safety, with researchers closely monitoring for side effects or issues. If SUM-191 had been approved for another condition, it would provide more confidence in its safety. Without specific safety data here, the key point is that researchers deem it safe enough for further testing.

Prospective trial participants should consult a healthcare professional to understand the implications of joining a trial. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising for pink eye?

Unlike traditional treatments for pink eye, such as antibiotic eye drops or antihistamines, SUM-191 is unique because it is an experimental drug specifically designed to target the underlying causes of pink eye. Researchers are excited about SUM-191 because it may offer a new mechanism of action that directly addresses inflammation and infection more effectively. If successful, SUM-191 has the potential to provide faster relief and reduce the duration of symptoms, setting it apart from current options.

What evidence suggests that SUM-191 might be an effective treatment for pink eye?

Research has shown that SUM-191 is being developed to treat bacterial conjunctivitis, also known as pink eye. This condition often causes redness, irritation, and discharge in the eyes. In this trial, participants will receive either SUM-191 or a placebo. While the effectiveness of SUM-191 is still under investigation, it is designed to target the bacteria causing the infection and help relieve these symptoms. Early studies have focused on the safety and tolerability of the treatment, which is an important first step before confirming its effectiveness. Although detailed results are not yet available, the treatment's design suggests it could offer a new way to manage bacterial conjunctivitis. ^{1 2 3 6 7}

Are You a Good Fit for This Trial?

This trial is for adults aged 18 and older who have bacterial conjunctivitis (pink eye) in at least one eye, are generally healthy, willing to stop wearing contact lenses during the study, and can follow all study procedures. Women must not be pregnant or breastfeeding.

Inclusion Criteria

7. The participant has triglyceride levels less than 150 mg/dL at Screening.

I have been diagnosed with bacterial conjunctivitis in at least one eye.

1. The participant is able to provide signed and dated, written informed consent prior to any trial specific procedures.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

Part 1: Single Ascending Dose (SAD)

Evaluation of single-dose safety and tolerability of SUM-191 in healthy participants

1 week

Multiple visits (in-person)

Part 2: Multiple Ascending Dose (MAD)

Evaluation of multiple-dose safety and tolerability of SUM-191 in healthy participants

2 weeks

Multiple visits (in-person)

Part 3: Treatment for Bacterial Conjunctivitis

Evaluation of multiple-dose efficacy and safety of SUM-191 in participants with bacterial conjunctivitis

1 week

Multiple visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• SUM-191

Trial Overview

The trial is testing SUM-191, a new treatment for bacterial conjunctivitis (pink eye), compared to a placebo. Participants are randomly assigned to receive either SUM-191 or placebo without knowing which one they get. The study looks at both safety and effectiveness.

How Is the Trial Designed?

Group I: SUM-191 Experimental Treatment 1 Intervention

Participants will receive SUM-191.

Group II: Placebo Placebo Group 1 Intervention

Participants will receive Placebo

Who Is Running the Clinical Trial?

Senju USA, Inc.

Lead Sponsor

Trials

3

Recruited

450+

Citations

1.

clinicaltrials.gov

clinicaltrials.gov/study/NCT07565103

Safety and Efficacy of SUM-191 for Patients With Bacterial ...

This is a seamless Phase I/II, randomized, double-masked, placebo-controlled, multicenter trial to evaluate single and multiple-dose safety ...

2.

withpower.com

withpower.com/trial/phase-2-conjunctivitis-bacterial-5-2026-a3b04

SUM-191 for Pink Eye · Info for Participants

Participants are monitored for safety and effectiveness after treatment. 4 weeks. What Are the Treatments Tested in This Trial? Interventions.

3.

okogen.com

okogen.com/okogen-inc-secures-3-3m-to-advance-phase-2b-clinical-program-for-pink-eye-acute-infectious-conjunctivitis/

Okogen Inc. Secures $3.3M to Advance Phase 2b Clinical ...

Okogen Inc., a company specializing in innovative eyecare solutions, today announced the successful completion of $3.3 million in financing.

4.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC4049531/

Conjunctivitis: A Systematic Review of Diagnosis and Treatment

To examine the diagnosis, management, and treatment of conjunctivitis, including various antibiotics and alternatives to antibiotic use in infectious ...

5.

clinicaltrials.gov

clinicaltrials.gov/study/NCT03861728

NCT03861728 | Viral Conjunctivitis Treatment Study

An unfavorable change in the health of a participant, including abnormal laboratory findings, that happens during a clinical study or within a certain amount of ...

6.

cdc.gov

cdc.gov/conjunctivitis/hcp/clinical-overview/index.html

Clinical Overview of Pink Eye (Conjunctivitis)

Viral conjunctivitis is very contagious and mostly spread through hand-to-eye contact by hands or objects that are contaminated with the virus.

7.

ilpi.com

ilpi.com/msds/ref/conjunctivitis.html

The MSDS HyperGlossary: Conjunctivitis

Conjunctivitis can be caused by physical injury, allergies, or chemical exposure, but is most commonly caused by bacterial or viral infection. These infections ...