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

40 Participants Needed

Trial Summary

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.

What data supports the effectiveness of the drug ABBV-444 Drops for Dry Eye Syndrome?

Research shows that similar treatments, like lipid-based artificial tears and semi-fluorinated alkane eye drops, have been effective in reducing symptoms of dry eye disease. These studies suggest that treatments targeting the eye's surface can help alleviate discomfort and improve tear film stability. ^{1 2 3 4 5}

What is the purpose of this trial?

This trial is testing ABBV-444 eye drops to help adults with Dry Eye Disease. The drops aim to keep eyes moist and reduce irritation by improving tear quality and reducing swelling. Participants will use the drops daily for a period and attend check-ups to monitor their progress.

Research Team

ABBVIE INC.

Principal Investigator

AbbVie

Eligibility Criteria

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

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

Treatment Details

Interventions

• ABBV-444

Participant Groups

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

Findings from Research

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]

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]

References

1. United States pubmed.ncbi.nlm.nih.gov

Efficacy, safety, and acceptability of a lipid-based artificial tear formulation: a randomized, controlled, multicenter clinical trial. [2018]

2. England pubmed.ncbi.nlm.nih.gov

Efficacy and safety of 1% and 2% rebamipide clear solution in dry eye disease: a multicenter randomized trial. [2023]

3. United States pubmed.ncbi.nlm.nih.gov

Semi-fluorinated Alkane Eye Drops Reduce Signs and Symptoms of Evaporative Dry Eye Disease After Cataract Surgery. [2021]

4. England pubmed.ncbi.nlm.nih.gov

Effect of a formulated eye drop with Leptospermum spp honey on tear film properties. [2021]

5. United States pubmed.ncbi.nlm.nih.gov

NOV03 for Dry Eye Disease Associated with Meibomian Gland Dysfunction: Results of the Randomized Phase 3 GOBI Study. [2023]