ABBV-444 Drops for Dry Eye Syndrome

Overseen By ABBVIE CALL CENTER

Age: 18+

Sex: Any

Trial Phase: Phase 3

Sponsor: AbbVie

Disqualifiers: Uncontrolled severe systemic disease, 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: Unknown

Duration: 4 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests ABBV-444 eye drops to determine their effectiveness and safety for individuals with Dry Eye Disease (DED). Dry Eye Disease occurs when eyes don't produce enough tears, leading to discomfort. Participants will use the drops at least twice daily for 30 days, with their symptoms and any side effects closely monitored. This trial may suit those who have used artificial tears for dry eyes in the past year and frequently experience dry eye symptoms. Participants must be prepared for frequent visits to a hospital or clinic during the study. 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.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. However, if you have an uncontrolled severe systemic disease, you may not be eligible to participate.

Is there any evidence suggesting that ABBV-444 is likely to be safe for humans?

Research has shown that ABBV-444 eye drops are safe to use. In earlier studies, participants tolerated these drops well, and no side effects were reported. This indicates that participants experienced no unexpected issues when using the drops. The studies examined how individuals with dry eye symptoms, such as burning and irritation, responded to the treatment. This suggests that ABBV-444 could be a safe option for those considering joining a clinical trial for dry eye symptoms. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising?

Unlike the standard treatments for dry eye syndrome, which often include artificial tears and anti-inflammatory eye drops, ABBV-444 introduces a novel approach by using a new active ingredient designed to provide longer-lasting relief. Researchers are excited about ABBV-444 because it offers the potential for more frequent application as needed, providing flexibility for users while showing effectiveness with a minimal use of twice daily. This could translate into better symptom management and improved quality of life for those suffering from this condition.

What evidence suggests that ABBV-444 might be an effective treatment for Dry Eye Disease?

Research has shown that ABBV-444 eye drops, used by participants in this trial, may benefit those with Dry Eye Disease (DED). In earlier studies, patients using ABBV-444 reported feeling better, particularly experiencing less burning and irritation. By Day 30 of using the drops, many patients noticed improvements compared to the start of the treatment. The drops are also considered safe, similar to regular artificial tears. Overall, evidence suggests that ABBV-444 could effectively relieve dry eye symptoms. ^{1 2 3 4 6}

Who Is on the Research Team?

ABBVIE INC.

Principal Investigator

AbbVie

Are You a Good Fit for This Trial?

Inclusion Criteria

Had used artificial tears for dry eyes within the past year

OSDI score of ≥ 18 and ≤ 65 (based upon a 0 to 100 scale) at Screening and Baseline Visits Three consecutive tear breakup time (TBUT) tests ≤ 10 seconds in at least 1 eye at Day -7 (screening)

Grade 1 to 4 (modified National Eye Institute [NEI] Grid, score range = 0 to 5) staining in at least 1 area of the cornea (5 areas examined) or conjunctiva (6 areas examined) that was related to dry eye in at least 1 eye at both at Screening and Baseline Visits

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

Treatment

Participants receive 1-2 drops of ABBV-444 in each eye as needed but minimally twice a day for 30 days

4 weeks

Regular visits at a hospital or clinic

Follow-up

Participants are monitored for safety and effectiveness after treatment

2-4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• ABBV-444

How Is the Trial Designed?

Group I: ABBV-444 Experimental Treatment 1 Intervention

Participants will administer 1-2 drops of ABBV-444 in each eye as needed but minimally twice a day for 30 days.

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

Published Research Related to This Trial

In a phase 3 study involving 599 adults with dry eye disease, NOV03 (perfluorohexyloctane) significantly improved eye dryness and corneal staining compared to saline, showing clinically meaningful benefits after 8 weeks of treatment.

The treatment was well tolerated, with most side effects being mild and no serious adverse events reported, indicating a favorable safety profile for NOV03 in managing dry eye disease associated with meibomian gland dysfunction.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

NOV03 for Dry Eye Disease Associated with Meibomian Gland Dysfunction: Results of the Randomized Phase 3 GOBI Study. Tauber, J., Berdy, GJ., Wirta, DL., et al.[2023]

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 volume compared to a placebo after 12 weeks of treatment.

The 2% rebamipide solution showed a greater reduction in corneal staining scores than the placebo, indicating its potential effectiveness in stabilizing the ocular surface in patients with dry eye disease.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Efficacy and safety of 1% and 2% rebamipide clear solution in dry eye disease: a multicenter randomized trial. Eom, Y., Chung, SH., Chung, TY., et al.[2023]

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 ... Artificial tears have been used for relief for symptoms of eye dryness. (burning, irritation, and discomfort) and have proven to be safe 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. clinicaltrials.gov clinicaltrials.gov/ct2/show/NCT05878067

A Study to Assess Symptom Relief and Product Tolerability ... An unfavorable change in the health of a participant, including abnormal laboratory findings, that happens during a clinical study or within a certain amount of ...

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

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

5. centerwatch.com centerwatch.com/clinical-trials/listings/NCT05878067/a-study-to-assess-symptom-relief-and-product-tolerability-of-abbv-444-drops-in-adult-participants

A Study to Assess Symptom Relief and Product Tolerability ... This study will evaluate symptom relief and tolerability of ABBV-444 eye drops in adult participants.

6. malacards.org malacards.org/card/keratoconjunctivitis_sicca

Keratoconjunctivitis Sicca (KCS) Keratoconjunctivitis sicca, also known as dry eye syndrome, is characterized by dryness, irritation, redness, discharge, blurred vision, and easily fatigued ...