NCT04030962|CompletedPhase 1/2ResultsDMCFDA Drug
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A Multicenter, Vehicle-controlled, Double-Masked, Randomized Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Exploratory Efficacy of AGN-242428 and AGN-231868 in Participants With Dry Eye Disease
Sponsor study identifier
interventional
292
1 country
11
Study Start
March 4, 2020
Actual (reported)Primary Completion
March 18, 2022
Actual (reported)Study Completion
March 18, 2022
Actual (reported)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.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
March 18, 2022
Actual (reported)Click on a node to explore related trials.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
July 10, 2019
Actual (reported)July 24, 2019
Actual (reported)March 4, 2020
Actual (reported)March 18, 2022
Actual (reported)March 18, 2022
Actual (reported)May 20, 2025
Actual (reported)Stage 1: Number of Participants With Adverse Events
An adverse event (AE) is defined as any untoward medical occurrence in a patient or clinical investigation participant administered a pharmaceutical product which does not necessarily have a causal relationship with this treatment.
Day 1 to Day 15
Stage 1: Area Under the Plasma Concentration Versus Time Curves After Single and Repeat Dose Administration
Following single dose administration, the area under the plasma concentration versus time curves from time 0 to time of the last measurable concentration (AUC0-tlast; Visit 3) was calculated. Following repeat dose administration twice daily for 14 days, the area under the plasma concentration versus time curves from time 0 to the end of the dosing interval (AUC0-τ; Visit 5) was calculated. For Visit 3 and Visit 5, tlast was 12 hours post-dose.
Day 2 and Day 15 (Predose and up to 12 hours postdose)
Stage 1: Area Under the Tear Concentration Versus Time Curves After Single and Repeat Dose Administration
Following single dose administration, the area under the tear concentration versus (vs) time curves from time 0 to time of the last measurable concentration (AUC0-tlast; Visit 3) was calculated. Following repeat dose administration twice daily for 14 days, the area under the tear concentration versus time curves from time 0 to the end of the dosing interval (AUC0-τ; Visit 5) was calculated. For Visit 3 and Visit 5, tlast was 12 hours post-dose.
Day 2 and Day 15 (Predose and up to 12 hours postdose)
Stage 1: Maximum Plasma Drug Concentration (Cmax) After Single and Repeat Dose Administration
Stage 2: Trough Plasma Concentration (Ctrough) and Plasma Concentration at 0.5 Hours Postdose (C0.5h)
Day 42
Stage 2: Trough Tear Concentration (Ctrough) and Tear Concentration at 0.5 Hours Postdose (C0.5h)
Day 42
Administration of AGN-242428 ophthalmic solution
Administration of matching placebo (vehicle) ophthalmic solution
Administration of AGN-231868 ophthalmic solution
Ophthalmic solution administered as a topical eye drop
Ophthalmic solution administered as a topical eye drop
Cornea and Cataract Consultants of Arizona /ID# 232769
Phoenix, Arizona, 85032, United States
The Eye Research Foundation /ID# 232696
Newport Beach, California, 92663-3637, United States
Vision Institute Central /ID# 239910
Colorado Springs, Colorado, 80907-7529, United States
The Eye Care Institute /ID# 232683
Louisville, Kentucky, 40206, United States
Andover Eye Associates /ID# 232689
Andover, Massachusetts, 01810, United States
Vita Eye Clinic /ID# 232721
Shelby, North Carolina, 28150, United States
Scott and Christie and Associates /ID# 232746
Tunon-Robinson I, Zheng S, Zhao C, Nguyen AK, Gomez-Freeman L. Selecting Vehicle Comparators in Dry Eye Disease Clinical Trials: Implications for Efficacy and Safety Assessment and Regulatory Outcomes. Ophthalmol Ther. 2026 Sep 7. doi: 10.1007/s40123-026-01490-2. Online ahead of print.
ABBVIE INC.
AbbVie
292 participants (actual enrollment reported by the registry).
First Submitted
July 10, 2019
First Posted
July 24, 2019
Study Start
March 4, 2020
Actual (reported)Study of INV-102 Ophthalmic Solution in Adults With Moderate Symptomatic Dry Eye Disease
Following single dose administration, the plasma Cmax (Visit 3) was calculated. Following repeat dose administration twice daily for 14 days, the plasma Cmax (Visit 5) was calculated.
Day 2 and Day 15 (Predose and up to 12 hours postdose)
Stage 1: Maximum Tear Drug Concentration (Cmax) After Single and Repeat Dose Administration
Following single dose administration, the tear Cmax (Visit 3) was calculated. Following repeat dose administration twice daily for 14 days, the tear Cmax (Visit 5) was calculated.
Day 2 and Day 15 (Predose and up to 12 hours postdose)
Stage 1: Time of Maximum Plasma Drug Concentration (Tmax) After Single and Repeat Dose Administration
Following single dose administration, the plasma Tmax (Visit 3) was calculated. Following repeat dose administration twice daily for 14 days, the plasma Tmax (Visit 5) was calculated.
Day 2 and Day 15 (Predose and up to 12 hours postdose)
Stage 1: Time of Maximum Tear Drug Concentration (Tmax) After Single and Repeat Dose Administration
Following single dose administration, the tear Tmax (Visit 3) was calculated. Following repeat dose administration twice daily for 14 days, the tear Tmax (Visit 5) was calculated.
Day 2 and Day 15 (Predose and up to 12 hours postdose)
Stage 1: Terminal Elimination Half-life of the Study Drugs (T1/2) in Plasma After Single Dose Administration
Following single dose administration, the plasma T1/2 (Day 2; Visit 3) was calculated.
Day 2 (Predose and up to 12 hours postdose).
Stage 1: Terminal Elimination Half-life of the Study Drugs (T1/2) in Plasma After Repeat Dose Administration
Following repeat dose administration twice daily for 14 days, plasma T1/2 (Day 15; Visit 5) was calculated.
Day 15 (Predose and up to 12 hours postdose)
Stage 1: Terminal Elimination Half-life of the Study Drugs (T1/2) in Tear After Single and Repeat Dose Administration
Following single dose administration, the tear T1/2 (Visit 3) was calculated. Following repeat dose administration twice daily for 14 days, tear T1/2 (Visit 5) was calculated.
Day 2 and Day 15 (Predose and up to 12 hours postdose)
Stage 1: Minimum Tear Drug Concentration at Steady State (Cmin,ss) After Repeat Dose Administration
Following repeat dose administration twice daily for 14 days, the tear Cmin,ss (Visit 5) was calculated.
Day 15 (Predose and up to 12 hours postdose)
Stage 1: Minimum Plasma Drug Concentration at Steady State (Cmin,ss) After Repeat Dose Administration
Following repeat dose administration twice daily for 14 days, the plasma Cmin,ss (Visit 5) was calculated.
Day 15 (Predose and up to 12 hours postdose)
Stage 1: Mean Accumulation Index of Drug Concentration (AI) After Repeat Dose Administration
Following repeat dose administration, the mean plasma and tear AI(area under curve \[AUC\]) was calculated. AI(AUC) is reported as the ratio of exposure (AUC) at steady state (Day 15) to the exposure after a single daily dose (Day 1). Values greater than one are indicative of drug accumulation with repeat dosing.
Day 15 (up to 12 hours) / Day 1 (up to 12 hours)
Stage 1: Mean Drop Tolerability Questionnaire Scores
Acute overall tolerability attributes of study interventions on an 8-question visual analog scale (VAS) Drop Tolerability Questionnaire. Visual scale ranges from 0 = not at all comfortable to 100 = very comfortable. Higher mean scores indicate higher levels of comfort with the assigned intervention.
Day 15
Stage 1: Percentage of Participants Who Met Criteria for Potentially Clinically Significant (PCS) Clinical Laboratory Values
The percentage of participants with non-PCS baseline value and met PCS criterion at least once postbaseline for clinical laboratory values.
Day 1 to Day 15
Stage 1: Percentage of Participants Who Met Criteria for PCS Vital Sign Values (Blood Pressure, Pulse Rate, Weight, Respiration Rate, and Temperature)
The percentage of participants who met PCS criteria at least once postbaseline for vital sign values (sitting systolic and diastolic blood pressure, pulse rate, weight, respiration rate, and temperature)
Day 1 to Day 15
Stage 1: Percentage of Participants Who Met Criteria for PCS Electrocardiogram (ECG) Values
The percentage of participants with PCS postbaseline (but not at baseline) ECG values for QRS interval, PR interval, and QTc (Fridericia)
Day 1 to Day 15
Stage 1: Mean Change From Baseline in Intraocular Pressure (IOP)
At least 2 measurements were taken by qualified study site personnel using a Goldmann applanation tonometer affixed to a slit lamp with the participant seated.
Day 1 to Day 15
Stage 1: Mean Change From Baseline in Best-corrected Visual Acuity (BCVA)
BCVA was quantified using the Early Treatment Diabetic Retinopathy Study (ETDRS) visual acuity protocol.
Day 1 to Day 15
Stage 1: Biomicroscopy: Percentage of Participants With Any Severity Increase From Baseline
The number of participants with any ophthalmoscopy findings of any severity increase from baseline at one or more visit.
Day 1 to Day 15
Stage 1: Percentage of Participants With Any Clinically Significant Postbaseline Findings During Dilated Fundus Examination
The fundus (posterior pole; periphery, when dilated) was evaluated for pathology. Ophthalmoscopy with clinically significant findings (per investigator assessment) postbaseline are reported.
Day 1 to Day 15
Stage 2: Number of Participants With Adverse Events
An adverse event (AE) is defined as any untoward medical occurrence in a patient or clinical investigation participant administered a pharmaceutical product which does not necessarily have a causal relationship with this treatment.
Day 1 to Day 42
Stage 2: Percentage of Participants With Potentially Clinically Significant (PCS) Clinical Laboratory Values
The percentage of participants who have PCS postbaseline clinical laboratory values at Day 42 (Visit 6).
Day 42
Stage 2: Percentage of Participants Who Met Criteria for PCS Vital Sign Values (Blood Pressure, Pulse Rate, Weight, Respiration Rate, and Temperature)
The percentage of participants who met PCS criteria at least once postbaseline for vital sign values at Day 42 (Visit 6) (sitting systolic and diastolic blood pressure, pulse rate, weight, respiration rate, and temperature). The numerator for the incidence is the number of participants with non-PCS baseline and at least one post-baseline value meeting the specific criterion at the visit. The denominator is the number of participants with non-PCS baseline and at least one post-baseline assessment at the visit. If a participant did not have a baseline value, but met the criterion post-baseline, then the participant is counted in the numerator.
Day 42
Stage 2: Percentage of Participants Who Met Criteria for PCS Electrocardiogram (ECG) Values
The percentage of participants who have PCS ECG at Visit 6 (but not baseline) pre and post-controlled adverse environment (CAE). The numerator for the incidence is the number of participants with non-PCS baseline and at least one post-baseline value meeting the specific criterion at the visit. The denominator is the number of participants with non-PCS baseline and at least one post-baseline assessment at the visit. If a participant did not have a baseline value, but met the criterion post-baseline, then the participant is counted in the numerator.
Day 42
Stage 2: Mean Change From Baseline in Intraocular Pressure (IOP)
At least 2 IOP measurements were taken by qualified study site personnel using a Goldmann applanation tonometer affixed to a slit lamp with the participant seated. Average intraocular pressure = mean of the 2 (or 3) measures in the study eye and non-study eye. Total fluorescein scores and Schirmer values were used to determine the study eye, and if both eyes qualified, the right eye was designated by default.
Day 1, Day 42
Stage 2: Mean Change From Baseline in Best-corrected Visual Acuity (BCVA)
BCVA was quantified using the Early Treatment Diabetic Retinopathy Study (ETDRS) visual acuity protocol in the study eye and the non-study eye. Total fluorescein scores and Schirmer values were used to determine the study eye, and if both eyes qualified, the right eye was designated by default.
Day 1, Day 42
Stage 2: Slit-lamp Biomicroscopy: Percentage of Participants With Any Clinically Significant Finding Postbaseline
Percentage of participants with a clinically significant finding postbaseline, post-CAE. A clinically significant finding is defined as more than one severity grade increase (worsening) from baseline or positive status change from absence at baseline to presence at postbaseline (not associated with a severity grade) in one or both eyes.
Day 1 to Day 42
Stage 2: Percentage of Participants With Any Clinically Significant Postbaseline Findings During Dilated Fundus Examination
The fundus (posterior pole; periphery, when dilated) was evaluated for pathology. Ophthalmoscopy with clinically significant findings (per investigator assessment) postbaseline are reported.
Day 1 to Day 42
Stage 2: Drop Tolerability Questionnaire Score (Post-controlled Adverse Environment)
Acute overall tolerability attributes of study interventions on an 8-question visual analog scale (VAS) Drop Tolerability Questionnaire. Participants completed questionnaires after exposure to a controlled adverse environment (CAE) for approximately 90 minutes. Visual scale ranges from 0 = not at all comfortable to 100 = very comfortable. Higher mean scores indicate higher levels of comfort with the assigned intervention.
Day 42 (Post-CAE)
Administration of matching placebo (vehicle) ophthalmic solution
Administration of AGN-242428 ophthalmic solution
Administration of matching placebo (vehicle) ophthalmic solution
Administration of AGN-231868 ophthalmic solution
Administration of matching placebo (vehicle) ophthalmic solution
Administration of AGN-242428 ophthalmic solution
Administration of matching placebo (vehicle) ophthalmic solution
Administration of AGN-231868 ophthalmic solution
Administration of matching placebo (vehicle) ophthalmic solution
Administration of Lifitegrast ophthalmic solution
Matching placebo (vehicle) ophthalmic solution administered as a topical eye drop
Matching placebo (vehicle) ophthalmic solution administered as a topical eye drop
Ophthalmic solution administered as a topical eye drop
Contact the study team to confirm eligibility.
Cranberry Township, Pennsylvania, 16066, United States
Total Eye Care, PA /ID# 232657
Memphis, Tennessee, 38119-5745, United States
Advancing Vision Research /ID# 232660
Smyrna, Tennessee, 37167, United States
Duplicate_Alpine Research Organization, Inc. /ID# 240508
Clinton, Utah, 84015-8562, United States
Piedmont Eye Center /ID# 232698
Lynchburg, Virginia, 24502, United States
Primary Completion
March 18, 2022
Actual (reported)Study Completion
March 18, 2022
Actual (reported)Last Updated
May 20, 2025
Results First Posted
May 20, 2025
Record last verified: 2025-05
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Source: ClinicalTrials.gov.
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