Lotilaner Ophthalmic Gel for Eye Redness

Enrolling by invitation at 1 trial location
Age: 18+
Sex: Any
Trial Phase: Phase 2
Sponsor: Tarsus Pharmaceuticals, Inc.
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)
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 aims to test a new eye gel, Lotilaner Ophthalmic Gel, for individuals with ocular rosacea, which causes eye redness and irritation. Researchers seek to determine how effectively the gel reduces these symptoms. Participants will receive either a high or low dose of the gel or a placebo, which contains no active drug. Individuals with moderate to severe ocular rosacea and regular eye redness may be suitable for this study. As a Phase 2 trial, this research focuses on assessing the treatment's effectiveness in an initial, smaller group of participants.

Do I need to stop my current medications for the trial?

You may need to stop taking any topical or other therapies that could affect your rosacea, as these are not allowed during the trial.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research has shown that lotilaner eye gel is generally well-tolerated by patients. Studies have found that users of this eye solution reported feeling comfortable, which is crucial for continuing treatment. Side effects were rare, with less than 2% of patients experiencing minor issues like a small lump on the eyelid (chalazion) or tiny spots on the eye's surface (punctate keratitis).

The FDA has already approved lotilaner for treating another eye condition called Demodex blepharitis, which adds confidence to its safety. The most common side effects are mild, such as pain at the application site, dry eyes, or slightly blurred vision, but these were not frequent. Overall, the evidence suggests that lotilaner is a promising and safe option for treating eye conditions.12345

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

Unlike standard treatments for eye redness, which often include over-the-counter vasoconstrictors or lubricating eye drops, Lotilaner Ophthalmic Gel introduces a new active ingredient, lotilaner. Lotilaner is primarily known for its ability to target specific parasites, but researchers are exploring its potential to reduce inflammation and redness in the eyes. This novel mechanism of action, different from conventional options, could offer a more targeted approach to managing eye redness. Additionally, the gel formulation may provide a more sustained release, potentially enhancing effectiveness and comfort for users. Researchers are excited about this treatment because it represents a fresh approach to a common condition, which may lead to quicker and more lasting relief.

What evidence suggests that lotilaner ophthalmic gel might be an effective treatment for ocular rosacea?

Research has shown that lotilaner eye gel may help treat certain eye problems. In earlier studies, this eye solution greatly reduced inflammation and redness. Specifically, one study found that 85% of patients experienced a significant drop in symptoms, compared to just 28% in the group not using the treatment. Another study demonstrated that lotilaner helped reduce eye mites, which can cause irritation and redness. This trial will test both high and low doses of lotilaner ophthalmic gel against a control vehicle to further evaluate its effectiveness and tolerability for similar eye issues.23467

Are You a Good Fit for This Trial?

This trial is for adults 18 and older with moderate to severe ocular rosacea who are willing to use contraception and follow study rules. People can't join if they have active eye infections, glaucoma, certain other eye diseases, are pregnant or breastfeeding, or have allergies to the study drug.

Inclusion Criteria

Use of acceptable methods of contraception
I have moderate to severe ocular rosacea.
I am willing and able to sign consent and follow the study requirements.
See 1 more

Exclusion Criteria

I have glaucoma, an eye infection, or an active eye disease.
Are currently enrolled in an investigational drug or device study
I am using a treatment that could affect my rosacea.
See 2 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive lotilaner ophthalmic gel or vehicle control for ocular rosacea

16 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

  • Lotilaner Ophthalmic Gel

Trial Overview

The study compares lotilaner ophthalmic gel (an eye medication) against a placebo gel in people with ocular rosacea. Participants are randomly assigned to receive either the real treatment or the placebo.

How Is the Trial Designed?

2

Treatment groups

Experimental Treatment

Group I: Treatment armExperimental Treatment1 Intervention
Group II: Control armExperimental Treatment1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

Tarsus Pharmaceuticals, Inc.

Lead Sponsor

Trials
10
Recruited
1,300+

Citations

Safety and Efficacy of Lotilaner Ophthalmic Solution (0.25 ...

Twice-daily treatment with lotilaner ophthalmic solution (0.25%) for 6 weeks demonstrated statistical significance for all outcome measures ...

Efficacy and Safety of Lotilaner Ophthalmic Solution 0.25% in ...

Lotilaner ophthalmic solution, 0.25%, offers a novel, effective therapy for this condition, enabling earlier intervention and improved outcomes for patients.

A Systematic Review and Meta-Analysis of the Safety and ...

The Lotilaner ophthalmic solution at 0.25% showed superior efficacy over the vehicle in reducing collarettes, achieving complete mite.

217603Orig1s000 CLINICAL REVIEW(S) - accessdata.fda.gov

The primary source for safety data for lotilaner ophthalmic solution was from the two multidose studies used for the efficacy analysis: TRS ...

Real-world study shows burden of Demodex blepharitis ...

Real-world study shows burden of Demodex blepharitis and how lotilaner ophthalmic solution, 0.25% can be effective. Juliana.

Important Safety Information

Other side effects in less than 2% of patients were chalazion/hordeolum and punctate keratitis. Handling the Container: Avoid allowing the tip of the dispensing ...

Lotilaner

Contraindications and Adverse Events ; Installation Site Pain · Dry Eye · Reduced Visual Acuity ; 7.9 · 1.5 · 0.5 ; 6.7 · 0.5 · 1.4.