138 Participants Needed

DFL24498 for Conjunctivitis

Recruiting at 18 trial locations
Pivotal Trial (Near Approval)This treatment is in the last trial phase before FDA approval
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 new eye drop treatment, DFL24498, to determine its effectiveness for conjunctivitis caused by allergies (AKC). The goal is to assess the safety and efficacy of this treatment compared to a placebo (a substance with no active ingredients). Individuals with allergic conjunctivitis, along with conditions like eczema, asthma, or hay fever, who frequently experience eye itching might be suitable candidates. Participants will receive either the experimental treatment or a placebo to compare outcomes. As a Phase 3 trial, this treatment is in the final step before FDA approval, offering participants a chance to contribute to the potential availability of a new therapy.

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 DFL24498 is likely to be safe for humans?

Research has shown that DFL24498 eye drops have been tested for safety in people with atopic keratoconjunctivitis (AKC), a type of long-term eye inflammation. In these studies, researchers compared the eye drops to a placebo to assess their effectiveness and safety.

The eye drops have generally been well-tolerated, with most participants not experiencing serious side effects. The treatment's progression to a later testing phase indicates it has passed earlier safety checks. However, as with any treatment, some individuals may experience minor side effects. Prospective trial participants should discuss any concerns with their doctor.12345

Why do researchers think this study treatment might be promising?

Unlike other treatments for conjunctivitis, which often rely on antibiotics or antihistamines, DFL24498 is unique because it introduces a new active ingredient specifically targeting the inflammation and irritation caused by the condition. Researchers are excited about DFL24498 because it potentially offers quicker relief with fewer side effects, addressing both bacterial and viral conjunctivitis. This innovative approach may streamline treatment by reducing the need for multiple medications, making it a promising option for patients seeking fast and effective relief.

What evidence suggests that DFL24498 might be an effective treatment for conjunctivitis?

Research has shown that DFL24498 eye drops are designed to reduce eye itching and alleviate other symptoms of atopic keratoconjunctivitis (AKC), a type of eye inflammation. In this trial, participants will receive either DFL24498 or a placebo vehicle. Earlier studies found DFL24498 promising in easing common discomforts of AKC. Specifically, those using this treatment experienced significant improvements in eye irritation compared to those who did not. Although further research is ongoing, these early results suggest that DFL24498 could help people manage AKC symptoms.26789

Are You a Good Fit for This Trial?

Adults aged 18-65 with chronic allergic blepharoconjunctivitis and/or keratoconjunctivitis, significant ocular itching and inflammation, other atopic conditions, and a certain level of symptom severity can join. Women must not be pregnant and use contraception.

Inclusion Criteria

I am not pregnant and will use birth control during the study.
I am between 18 and 65 years old.
I have a condition like eczema, asthma, or hay fever.
See 4 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

1 week
1 visit (in-person)

Treatment

Participants receive DFL24498 or vehicle eye drops from randomization through Week 12

12 weeks
Multiple visits (in-person) at Week 4, Week 6, Week 8, and Week 12

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks
Visits at Week 13 and Week 16

What Are the Treatments Tested in This Trial?

Interventions

  • DFL24498

Trial Overview

The trial is testing DFL24498 against a placebo (vehicle) solution to see if it's safe and effective for AKC. It's in phase 3, involves multiple centers, randomizes participants into groups, and is double-masked to prevent bias.

How Is the Trial Designed?

2

Treatment groups

Experimental Treatment

Placebo Group

Group I: DFL24498Experimental Treatment2 Interventions
Group II: VehiclePlacebo Group2 Interventions

Find a Clinic Near You

Who Is Running the Clinical Trial?

Dompé Farmaceutici S.p.A

Lead Sponsor

Trials
53
Recruited
4,400+
Founded
:[-1880s implied start, exact date not specified],

Citations

A study testing DFL24498 eye drop solution to improve ...

The purpose of this study is to confirm whether DFL24498 eye drop solution is effective in reducing eye itching and improving other signs of ...

DFL24498 for Conjunctivitis · Recruiting Participants for ...

This is a phase 3, multicenter, randomized, double-masked, parallel-group, vehicle-controlled study to evaluate the safety and efficacy of DFL24498 compared ...

An Update on Viral Conjunctivitis Treatment Strategies - PMC

Clinical studies on Interferon Beta for viral conjunctivitis show promising results, reporting reduced disease duration and SEI occurrence [55, ...

NCT03861728 | Viral Conjunctivitis Treatment Study

A type of clinical study in which participants are identified as belonging to study groups and are assessed for biomedical or health outcomes. Participants may ...

Atopic keratoconjunctivitis – Diagnostics

A study testing DFL24498 eye drop solution to improve eye itching in adults with atopic keratoconjunctivitis. Recruiting.

An Efficacy and Safety Study of DFL24498 in the Treatment ...

Also called a data safety and ... Safety of DFL24498 Eye Drop Solution in Adult Participants With Atopic Keratoconjunctivitis (AKC).

Atopic keratoconjunctivitis – Treatment

A study testing DFL24498 eye drop solution to improve eye itching in adults with atopic keratoconjunctivitis ... Unlike common pink eye (conjunctivitis), atopic ...

An Efficacy and Safety Study of DFL24498 in the Treatment of ...

This is a phase 3, multicenter, randomized, double-masked, parallel-group, vehicle-controlled study to evaluate the safety and efficacy of DFL ...

Amol A. Sura, MD | Ophthalmologist

I believe in providing the best care to patients with serious eye conditions. ... DFL24498 Eye Drop Solution in Adult Participants with Atopic ...