DFL24498 for Conjunctivitis

Recruiting at 18 trial locations

Age: 18+

Sex: Any

Trial Phase: Phase 3

Sponsor: Dompé Farmaceutici S.p.A

Disqualifiers: Ocular infection, Intraocular inflammation, Cancer, Monocular, Unstable systemic disease, others

Pivotal Trial (Near Approval) This treatment is in the last trial phase before FDA approval

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: 18

Duration: 12 weeks

138 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This is a phase 3, multicenter, randomized, double-masked, parallel-group, vehicle-controlled study to evaluate the safety and efficacy of DFL24498 compared with vehicle ophthalmic solution, in participants with AKC. Approximately 138 participants who meet all eligibility criteria will be enrolled in the study.

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.

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?

Group I: DFL24498 Experimental Treatment 2 Interventions

Participants will be administered with DFL24498 eye drops in both eyes.

Group II: Vehicle Placebo Group 2 Interventions

Participants will be administered with vehicle eye drops in both eyes.

Who Is Running the Clinical Trial?

Dompé Farmaceutici S.p.A

Lead Sponsor

Trials

53

Recruited

4,400+

Founded

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