A Study of the Drugs AGN-242428 and AGN-231868 in Participants With Dry Eye Disease

Completed · Phase 1/Phase 2 · Has a placebo group

Conditions studied: Dry Eye Disease, Dry Eye Syndrome

In brief

This was a 2-stage study in which Stage 1 evaluated the safety of AGN-242428 and AGN-231868, how well they are tolerated, and how they move through the body when administered. After the sponsor's determination of adequate safety and tolerability of the interventions in Stage 1, Stage 2 began. Stage 2 also evaluated the safety and tolerability of AGN-242428 and AGN-231868, how effective they are in treating dry eye disease (DED), and assessed the plasma and tear exposure of both ophthalmic solutions.

Key facts

Study ID: NCT04030962
Run by: AbbVie
People needed: 292
Starts: 2020-03-04
Expected to finish: 2022-03-18
Last updated by the study team: 2025-05-20

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

Stage 1 \& Stage 2:
Male participants willing to minimize the risk of inducing pregnancy for the duration of the clinical study.
Female participants willing to minimize the risk of inducing pregnancy for the duration of the clinical study.
Capable of giving signed informed consent, which includes compliance with the requirements and restrictions listed in the informed consent form and in this protocol.
Stage 1:
Both of the following signs of DED in at least 1 eye at Screening and Baseline visits (the same eye does not need to qualify at both visits):
Total corneal fluorescein staining score ≥ 2 and ≤ 9 based on the NEI grading scale, with no score > 2 in any 1 region;
Schirmer test with topical anesthesia score ≥ 1 and ≤ 10 mm/5 min.
Stage 2:
ALL of the following in at least 1 eye at both the Screening and Baseline visits and the same eye must qualify at both Screening and Baseline visits:
Corneal fluorescein staining score ≥ 2 in at least 1 eye region and a total corneal fluorescein staining score of ≥ 4 and ≤ 12 based on NEI grading scale;
Schirmer test with topical anesthesia score ≥ 2 and ≤ 10 mm/5 min;
Mean TBUT of ≥ 2 and ≤ 10 seconds.
Stage 1:
Symptoms of DED at both the Screening and Baseline visits as defined by an OSDI total score of ≥ 13 with ≤ 3 responses of "not applicable (NA)."
Stage 2:
Symptoms of DED at both the Screening and Baseline visits as defined by both:
OSDI score of ≥ 23 with ≤ 3 responses of "not applicable (NA)" in at least 1 eye;
Eye Dryness Score (assessed using the Visual Analog Scale [VAS] Symptom Items score ≥ 30).

You may not qualify if…

Current diagnosis of glaucoma or ocular hypertension; evidence of glaucoma or mean intraocular pressure > 21 mm Hg determined by Goldmann applanation tonometry, in either eye.
Diagnosis of recurrent, ongoing, or active ocular infection including, but not limited to herpes simplex or zoster, vaccinia, varicella, tuberculosis of the eye, acanthamoeba, or fungal disease.
Participation in a blood or plasma donation program within 60 or 30 days, respectively, prior to study intervention administration.
Positive test results for anti-HIV type 1 and 2, hepatitis B surface antigen, or anti-hepatitis C virus at the Screening visit.
Positive test results for benzoylecgonine (cocaine), methadone, barbiturates, amphetamines, benzodiazepines, alcohol, cannabinoids, opiates, or phencyclidine at the Screening or Baseline visits.
Positive pregnancy test at Screening or Baseline visits.
Currently breastfeeding or plans to breastfeed during the study.
History or presence of any ocular disorder or condition (other than DED) in either eye that would, in the opinion of the investigator, likely interfere with the interpretation of the study results or participant safety.

Where it is running

Cornea and Cataract Consultants of Arizona /ID# 232769 — Phoenix, Arizona, United States
The Eye Research Foundation /ID# 232696 — Newport Beach, California, United States
Vision Institute Central /ID# 239910 — Colorado Springs, Colorado, United States
The Eye Care Institute /ID# 232683 — Louisville, Kentucky, United States
Andover Eye Associates /ID# 232689 — Andover, Massachusetts, United States
Vita Eye Clinic /ID# 232721 — Shelby, North Carolina, United States
Scott and Christie and Associates /ID# 232746 — Cranberry Township, Pennsylvania, United States
Total Eye Care, PA /ID# 232657 — Memphis, Tennessee, United States
Advancing Vision Research /ID# 232660 — Smyrna, Tennessee, United States
Duplicate_Alpine Research Organization, Inc. /ID# 240508 — Clinton, Utah, United States
Piedmont Eye Center /ID# 232698 — Lynchburg, Virginia, United States

Full record on ClinicalTrials.gov

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