ABBV-444 for Dry Eye Syndrome

Recruiting at 9 trial locations

Overseen By ABBVIE CALL CENTER

Age: 18+

Sex: Any

Trial Phase: Phase 3

Sponsor: AbbVie

Must be taking: Artificial tears

Disqualifiers: Uncontrolled severe systemic disease, contact lenses, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

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: 4

Duration: 12 weeks

250 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new eye drop, ABBV-444, to determine its effectiveness for Dry Eye Disease (DED), a condition where eyes lack sufficient lubrication. The study compares ABBV-444 with REFRESH OPTIVE® over 90 days to evaluate which works better. Participants will be divided into two groups, each receiving one type of eye drop. Eligible participants are adults diagnosed with DED who have used artificial tears in the past six months. The trial requires multiple visits to the study site for check-ups and assessments. As a Phase 3 trial, this study represents the final step before FDA approval, offering participants a chance to contribute to the potential availability of a new treatment.

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

The trial information does not specify if you need to stop taking your current medications. However, it mentions that participants with uncontrolled severe systemic diseases may be excluded, so it's best to discuss your specific medications with the study team.

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

Research has shown that ABBV-444 eye drops are safe to use. In earlier studies, participants handled these drops well, and no side effects were reported. ABBV-444 is being tested for dry eye disease (DED), which occurs when eyes don't produce enough tears or the tears lack quality, leading to dryness and discomfort.

The study compares ABBV-444 to Refresh Optive UD, another type of eye drop. ABBV-444 has been shown to quickly reduce dry eye symptoms. These findings suggest that ABBV-444 is generally safe and well-tolerated by users. ^{1 2 3 4 5}

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

Researchers are excited about ABBV-444 for treating dry eye syndrome because it offers a fresh approach compared to standard treatments like artificial tears, prescription eye drops, or anti-inflammatory medications. Unlike these existing options, which primarily focus on providing lubrication or reducing inflammation, ABBV-444 could potentially offer a new mechanism of action that directly addresses underlying causes of dry eye. This treatment involves consistent application at least twice a day, which may enhance its effectiveness over time. By targeting the condition differently, ABBV-444 holds promise for individuals who haven't found relief with current therapies.

What evidence suggests that this trial's treatments could be effective for Dry Eye Disease?

Research has shown that ABBV-444, which participants in this trial may receive, might help improve symptoms of Dry Eye Disease (DED). In a study with 220 patients, both 1% and 2% solutions of ABBV-444 significantly increased the time tears stayed on the eye before breaking up. This means ABBV-444 helps keep the eye surface moist longer. Patients reported feeling better with ABBV-444 compared to earlier treatments, indicating relief from dry eye symptoms. These findings suggest that ABBV-444 could be a promising option for managing dry eyes. ^{1 3 5 6 7}

Who Is on the Research Team?

ABBVIE INC.

Principal Investigator

AbbVie

Are You a Good Fit for This Trial?

Adults with Dry Eye Disease (DED) can join this study. They must have completed a 7-day period using REFRESH PLUS eye drops before starting the trial. People who don't meet the specific requirements for DED severity or have other eye conditions that might interfere with the study cannot participate.

Inclusion Criteria

I have mild to severe dry eye symptoms confirmed by tests.

Three consecutive tear breakup time (TBUT) tests of ≤ 10 seconds in at least 1 eye at both the Screening and Baseline Visits

I have used artificial tears for dry eye within the last 6 months.

Exclusion Criteria

Participant has worn contact lenses in the last 90 days prior to the Screening Visit and/or participant anticipates contact lens wear during the study

Participant has uncontrolled severe systemic disease that would put safety of the subject at risk through participation or prevent/confound protocol-specified assessments

I have no surgeries planned that would affect my participation in the study.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

1 visit (in-person)

Run-in

Participants complete a 7-day run-in period using REFRESH PLUS® eye drops

1 week

1 visit (in-person)

Treatment

Participants receive ABBV-444 or REFRESH OPTIVE® Unit Dose eye drops for 90 days

12 weeks

Multiple 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

• ABBV-444

Trial Overview

The trial is testing a new artificial tear solution, ABBV-444, against Refresh Optive UD to see which one is better at treating dry eyes over a 90-day period. Participants are randomly chosen to use either ABBV-444 or Refresh Optive after an initial run-in phase.

How Is the Trial Designed?

Group I: ABBV-444 Experimental Treatment 1 Intervention

Participant will receive ABBV-444 as needed but at least twice a day for 90 days.

Group II: REFRESH OPTIVE UD Active Control 1 Intervention

Participant will receive REFRESH PLUS as needed but at least twice a day for 90 days. (Refresh Plus is the run-in medication for 7-10 days before study treatment assignment)

Who Is Running the Clinical Trial?

AbbVie

Lead Sponsor

Trials

1,079

Recruited

535,000+

Founded

2013

Headquarters

North Chicago, USA

Known For

Immunology treatments

Top Products

Humira (adalimumab), Skyrizi (risankizumab), Rinvoq (upadacitinib)

Dr. Roopal Thakkar

AbbVie

Chief Medical Officer since 2023

MD from Wayne State University School of Medicine

Robert A. Michael

AbbVie

Chief Executive Officer

Bachelor's degree in Finance from the University of Illinois

Citations

1.

cdn.clinicaltrials.gov

cdn.clinicaltrials.gov/large-docs/67/NCT05878067/Prot_SAP_000.pdf

Title A Patient Experience Study with ABBV-444 for ...

The purpose of this assessment is to capture a range of ocular surface symptoms, including symptoms related to dry eye, their severity, and ...

2.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC11830937/

Patient Experience with ABBV-444, a Proof-of-Concept ...

Patients reported consistently improved experiences in PEDE survey questions on Day 30 compared with Day 14. The best patient experience ...

3.

abbvieclinicaltrials.com

abbvieclinicaltrials.com/study/?id=P24-203

A Study to Assess Symptom Relief and Product Tolerability of ...

This study will evaluate symptom relief and tolerability of ABBV-444 eye ... ABBV-444 is being developed for the treatment of Dry Eye Disease (DED). This ...

4.

withpower.com

withpower.com/trial/phase-3-dry-eye-syndromes-4-2023-b2816

ABBV-444 Drops for Dry Eye Syndrome · Info for Participants

In a study involving 220 patients with dry eye disease, both 1% and 2% rebamipide solutions significantly improved tear film break-up time (TBUT) and tear ...

5.

clinicaltrials.gov

clinicaltrials.gov/study/NCT07284381?lastUpdPost=2020-01-16_

NCT07284381 | A Clinical Study to Evaluate the Effect and ...

The purpose of this study is to compare the efficacy and safety of a new artificial tear formulation (ABBV-444) with Refresh Optive UD for 90 ...

6.

pubmed.ncbi.nlm.nih.gov

pubmed.ncbi.nlm.nih.gov/39963316/

Patient Experience with ABBV-444, a Proof-of-Concept ...

Continuous daily treatment with ABBV-444 reduced DED symptom severity over 30 days and demonstrated rapid onset of action within 30 seconds ...

7.

malacards.org

malacards.org/card/keratoconjunctivitis_sicca

Keratoconjunctivitis Sicca (KCS)

Integrated disease information for Keratoconjunctivitis Sicca including associated genes, mutations, phenotypes, pathways, drugs, and more - integrated from ...