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

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ClinicalTrials.gov Identifier: NCT04030962
Recruitment Status : Recruiting
First Posted : July 24, 2019
Last Update Posted : September 14, 2020
Sponsor:
Information provided by (Responsible Party):
Allergan

Brief Summary:
This study will evaluate the safety of AGN-242428 and AGN-231868, how well they are tolerated, how they move through the body when administered, and how effective they are in treating dry eye disease.

Condition or disease Intervention/treatment Phase
Dry Eye Disease Dry Eye Syndrome Drug: AGN-242428 Drug: AGN-231868 Other: AGN-242428 Vehicle Other: AGN-231868 Vehicle Phase 1 Phase 2

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 72 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: 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
Actual Study Start Date : March 4, 2020
Estimated Primary Completion Date : December 31, 2020
Estimated Study Completion Date : December 31, 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Eye Diseases

Arm Intervention/treatment
Experimental: AGN-242428 Cohort 1A
Administration of AGN-242428 ophthalmic solution
Drug: AGN-242428
Ophthalmic solution administered as a topical eye drop

Experimental: AGN-242428 Cohort 1B
Administration of AGN-242428 ophthalmic solution
Drug: AGN-242428
Ophthalmic solution administered as a topical eye drop

Experimental: AGN-242428 Cohort 1C
Administration of AGN-242428 ophthalmic solution
Drug: AGN-242428
Ophthalmic solution administered as a topical eye drop

Experimental: AGN-231868 Cohort 1A
Administration of AGN-231868 ophthalmic solution
Drug: AGN-231868
Ophthalmic solution administered as a topical eye drop

Experimental: AGN-231868 Cohort 1B
Administration of AGN-231868 ophthalmic solution
Drug: AGN-231868
Ophthalmic solution administered as a topical eye drop

Experimental: AGN-231868 Cohort 1C
Administration of AGN-231868 ophthalmic solution
Drug: AGN-231868
Ophthalmic solution administered as a topical eye drop

Placebo Comparator: AGN-242428 Vehicle
Administration of matching placebo (vehicle) ophthalmic solution
Other: AGN-242428 Vehicle
Matching placebo (vehicle) ophthalmic solution administered as a topical eye drop

Placebo Comparator: AGN-231868 Vehicle
Administration of matching placebo (vehicle) ophthalmic solution
Other: AGN-231868 Vehicle
Matching placebo (vehicle) ophthalmic solution administered as a topical eye drop




Primary Outcome Measures :
  1. The incidence of adverse events (safety and tolerability) [ Time Frame: 15 Day Treatment Period ]
    The number of participants who experience one or more treatment emergent adverse events (TEAE)

  2. Area under the plasma concentration versus time curve from time 0 to time of the last measurable concentration (AUC0-tlast) after a single dose administration [ Time Frame: Predose and up to 12 hours postdose ]
  3. Area under the tear concentration versus time curve from time 0 to time of the last measurable concentration (AUC0-tlast) after a single dose administration [ Time Frame: Predose and up to 12 hours postdose ]
  4. Maximum plasma drug concentration (Cmax) after a single dose administration [ Time Frame: Predose and up to 12 hours postdose ]
  5. Maximum tear drug concentration (Cmax) after a single dose administration [ Time Frame: Predose and up to 12 hours postdose ]
  6. Time of maximum plasma drug concentration (Tmax) after a single dose administration [ Time Frame: Predose and up to 12 hours postdose ]
  7. Time of maximum tear drug concentration(Tmax) after a single dose administration [ Time Frame: Predose and up to 12 hours postdose ]
  8. Terminal elimination half-life (t1/2) after a single dose administration [ Time Frame: Predose and up to 12 hours postdose ]
  9. Area under the plasma concentration versus time curve from time 0 to the end of the dosing interval (AUC0-τ) following repeat dose administration [ Time Frame: Predose and up to 12 hours postdose ]
  10. Area under the tear concentration versus time curve from time 0 to the end of the dosing interval (AUC0-τ) following repeat dose administration [ Time Frame: Predose and up to 12 hours postdose ]
  11. Maximum plasma drug concentration (Cmax) following repeat dose administration [ Time Frame: Predose and up to 12 hours postdose ]
  12. Maximum tear drug concentration (Cmax) following repeat dose administration [ Time Frame: Predose and up to 12 hours postdose ]
  13. Time of maximum plasma drug concentration (Tmax) following repeat dose administration [ Time Frame: Predose and up to 12 hours postdose ]
  14. Time of maximum tear drug concentration (Tmax) following repeat dose administration [ Time Frame: Predose and up to 12 hours postdose ]
  15. Minimum plasma drug concentration at steady state (Cmin,ss) following repeat dose administration [ Time Frame: Predose and up to 12 hours postdose ]
  16. Minimum tear drug concentration at steady state (Cmin,ss) following repeat dose administration [ Time Frame: Predose and up to 12 hours postdose ]
  17. Terminal elimination half-life of the study drugs (t1/2) following repeat dose administration [ Time Frame: Predose and up to 12 hours postdose ]
  18. Accumulation index of drug concentration (AI) following repeat dose administration [ Time Frame: Predose and up to 12 hours postdose ]
  19. Drop Tolerability Questionnaire Score [ Time Frame: 15 Day Treatment Period ]
    Rate of the 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.

  20. Number of patients experiencing one or more adverse events (AEs) during the 15 day treatment period [ Time Frame: 15 Day Treatment Period ]
  21. Potentially clinically significant (PCS) clinical laboratory values [ Time Frame: 15 Day Treatment Period ]
    The percentage of participants who have PCS postbaseline clinical laboratory values

  22. Vital sign values (blood pressure, pulse rate, weight, respiration rate, and temperature) [ Time Frame: 15 Day Treatment Period ]
    The percentage of participants who have PCS postbaseline vital sign values

  23. Electrocardiogram (ECG) heart rate [ Time Frame: 15 Day Treatment Period ]
    The percentage of participants who have PCS postbaseline ECG

  24. ECG PR interval [ Time Frame: 15 Day Treatment Period ]
    The percentage of participants who have PCS postbaseline ECG

  25. ECG QRS duration [ Time Frame: 15 Day Treatment Period ]
    The percentage of participants who have PCS postbaseline ECG

  26. ECG QT interval [ Time Frame: 15 Day Treatment Period ]
    The percentage of participants who have PCS postbaseline ECG

  27. ECG QTc [ Time Frame: 15 Day Treatment Period ]
    The percentage of participants who have PCS postbaseline ECG

  28. Change from baseline in intraocular pressure (IOP) [ Time Frame: 15 Day Treatment Period ]
  29. Change from baseline in best-corrected visual acuity (BCVA) [ Time Frame: 15 Day Treatment Period ]
  30. Change from baseline in slit-lamp biomicroscopy [ Time Frame: 15 Day Treatment Period ]
  31. Change from baseline in dilated fundus examination [ Time Frame: 15 Day Treatment Period ]


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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
  • 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
  • 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)".

Exclusion Criteria:

  • 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04030962


Contacts
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Contact: Clinical Trials Registry Team 1-877-277-8566 IR-CTRegistration@Allergan.com

Locations
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United States, Massachusetts
Andover Eye Associates Recruiting
Andover, Massachusetts, United States, 01810
Contact: Study Coordinator    978-475-0705      
United States, Tennessee
Total Eye Care Recruiting
Memphis, Tennessee, United States, 38119
Sponsors and Collaborators
Allergan
Investigators
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Study Director: Anna Papinska Allergan
Additional Information:
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Responsible Party: Allergan
ClinicalTrials.gov Identifier: NCT04030962    
Other Study ID Numbers: 2012-201-005
First Posted: July 24, 2019    Key Record Dates
Last Update Posted: September 14, 2020
Last Verified: September 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: Allergan will share de-identified patient-level data and study-level data including protocols and clinical study reports for phase 2 - 4 trials completed after 2008 that are registered to ClinicalTrials.gov or EudraCT, have received regulatory approval in the United States and/or the European Union in a given indication and the primary manuscript from the trial has been published. To request access to the data, the researcher must sign a data use agreement and any shared data is to be used for non-commercial purposes. More information can be found on http://www.allerganclinicaltrials.com/.
Supporting Materials: Study Protocol
Time Frame: After having received regulatory approval in the United States and/or the European Union in a given indication and the primary manuscript from the trial has been published.
Access Criteria: To request access to the data, the researcher must sign a data use agreement and any shared data is to be used for non-commercial purposes.
URL: http://www.allerganclinicaltrials.com/

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Keratoconjunctivitis Sicca
Dry Eye Syndromes
Eye Diseases
Keratoconjunctivitis
Conjunctivitis
Conjunctival Diseases
Keratitis
Corneal Diseases
Lacrimal Apparatus Diseases