160 Participants NeededMy employer runs this trial

Licaminlimab for Dry Eye Syndrome

(PREDICT-1 Trial)

Recruiting at 13 trial locations
OC
Overseen ByOculis Chief Development Officer
Age: 18+
Sex: Any
Trial Phase: Phase 2 & 3
Sponsor: Oculis
Prior Safety DataThis treatment has passed at least one previous human trial

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a treatment called licaminlimab, a medicated eye drop, to determine its effectiveness for people with Dry Eye Disease. Researchers aim to assess its efficacy and safety compared to a placebo (a solution without the active drug). Participants must have received a Dry Eye Disease diagnosis within the last six months, use over-the-counter eye drops, and be open to genetic testing. As a Phase 2/3 trial, this study is crucial for evaluating the treatment's effectiveness in a larger group and represents a significant step toward potential FDA approval, offering participants a chance to contribute to advancing medical care.

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 licaminlimab is likely to be safe for humans?

Research has shown that licaminlimab is generally well-tolerated by people with dry eye disease. Studies found that participants using licaminlimab experienced more comfort in their eyes compared to those using a placebo, which contains no active medicine. Serious side effects were not commonly reported, indicating the treatment's safety. Any mild side effects resembled those from regular eye drops.

In earlier studies, licaminlimab provided significant benefits, such as reduced eye inflammation and discomfort, compared to a placebo. These results suggest that the treatment is both effective and safe for eye health. For those considering joining a trial, these findings indicate that licaminlimab is a promising option with a good safety profile.12345

Why do researchers think this study treatment might be promising for Dry Eye Disease?

Licaminlimab is unique because it introduces a new active ingredient specifically targeting dry eye syndrome. Unlike current treatments, which often include artificial tears or anti-inflammatory drops, licaminlimab is designed to address the underlying causes of inflammation in the eyes more directly. Researchers are excited about its potential to provide longer-lasting relief and improve overall eye health by targeting specific inflammatory pathways. This approach could offer a significant advancement over existing options, which mainly focus on temporary symptom relief.

What evidence suggests that licaminlimab might be an effective treatment for Dry Eye Disease?

Research has shown that licaminlimab, which participants in this trial may receive, effectively treats dry eye disease. Studies have found it alleviates symptoms such as eye discomfort and reduces eye inflammation. One study demonstrated that licaminlimab performed significantly better than a placebo. Patients using licaminlimab reported increased comfort and improved health over time. These findings suggest licaminlimab could be a promising treatment for dry eye disease.14678

Are You a Good Fit for This Trial?

This trial is for people diagnosed with Dry Eye Disease in the past 6 months who use over-the-counter eye drops and agree to genetic testing.

Inclusion Criteria

I agree to have my genes tested.
I meet a main requirement for the study.
I was diagnosed with Dry Eye Disease in the past 6 months.
See 1 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive either licaminlimab or vehicle ophthalmic solution

8 weeks
4 visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks
2 visits (in-person)

What Are the Treatments Tested in This Trial?

Interventions

  • Licaminlimab

Trial Overview

The study compares licaminlimab eye drops to a placebo (inactive solution) in treating Dry Eye Disease. All participants first use artificial tears before starting the main treatments.

How Is the Trial Designed?

2

Treatment groups

Experimental Treatment

Placebo Group

Group I: licaminlimabExperimental Treatment2 Interventions
Group II: VehiclePlacebo Group2 Interventions

Find a Clinic Near You

Who Is Running the Clinical Trial?

Oculis

Lead Sponsor

Trials
9
Recruited
1,700+

Citations

Licaminlimab in the treatment of dry eye disease - IOVS

Licaminlimab showed larger changes from baseline than vehicle on multiple endpoints including fluorescein staining in the inferior region, corneal sum, and ...

NCT05896670 | Safety and Efficacy of Licaminlimab ...

The main question it aims to answer is if licaminlimab ophthalmic solution is more effective than vehicle in treating signs of dry eye disease. Detailed ...

3.

pubmed.ncbi.nlm.nih.gov

pubmed.ncbi.nlm.nih.gov/35821785/

Topical Anti-TNFα Agent Licaminlimab (OCS-02) Relieves ...

Conclusion: Topical ocular licaminlimab demonstrated statistically significant improvement in global ocular discomfort score compared to Vehicle ...

Oculis Announces Positive Topline Results of Phase 2b ...

Oculis announces positive topline results of Phase 2b RELIEF trial with Licaminlimab, designed to transform the treatment paradigm of dry eye disease.

Oculis Announces Topline Results of Phase 2B RELIEF ...

Rapid and favorable treatment effect in favor of licaminlimab on corneal inflammation was observed as early as Day 15 that was significant at ...

Topical Anti-TNFα Agent Licaminlimab (OCS-02) Relieves ...

Topical ocular licaminlimab demonstrated statistically significant improvement in global ocular discomfort score compared to Vehicle in patients with severe ...

OCS-02: Dry Eye Prescription Medication

Licaminlimab, an anti-TNFα eye drop candidate specifically designed to treat ocular inflammation, has the potential to transform the treatment paradigm of dry ...

Keratoconjunctivitis Sicca (KCS)

... Safety of Licaminlimab for the Treatment of Dry Eye Disease, Completed, NCT05896670, Phase 2, licaminlimab. 491, A Phase 1/2, First-in-Human, Double-Masked ...