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A Phase 2b Study Evaluating the Safety and Efficacy of AR-15512 Ophthalmic Solution for the Treatment of Dry Eye Disease (COMET-1)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04498182
Recruitment Status : Completed
First Posted : August 4, 2020
Last Update Posted : July 21, 2022
Sponsor:
Information provided by (Responsible Party):
Aerie Pharmaceuticals

Brief Summary:
This is a Phase 2b, multicenter, vehicle-controlled, double-masked, randomized study. All subjects enrolled will have dry eye disease. The study consists of Screening and Baseline visits to determine eligibility followed by efficacy assessments at Day 14 (Visit 3), 28 (Visit 4) and 84 (Visit 5 / Study Exit). Safety will be assessed at all study visits. All subjects will be exposed to the Controlled Adverse Environment (CAE®) at the Screening, Baseline, Day 28 and Day 84 visits. Only subjects who qualify based on inclusion/exclusion criteria, will be enrolled in the study and randomized at a 1:1:1 ratio within each site, to receive AR-15512 0.0014%, AR-15512 0.003% or AR-15512 vehicle to be administered as 1 drop in each eye twice daily for 84 days.

Condition or disease Intervention/treatment Phase
Dry Eye Disease Drug: AR15512 Drug: Vehicle Phase 2

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 369 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Subjects will be randomized at a 1:1:1 ratio within each site to receive AR-15512 0.0014%, AR-15512 0.003% or AR 15512 vehicle
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Masking Description: During the randomized treatment period, the investigator and site staff performing eligibility / efficacy and safety assessments and the subjects will be masked. Subjects will be informed that they all will receive vehicle at some point in the study, but the exact timing will not be specified.
Primary Purpose: Treatment
Official Title: A Phase 2b Study Evaluating the Safety and Efficacy of AR-15512 Ophthalmic Solution for the Treatment of Dry Eye Disease (COMET-1)
Actual Study Start Date : November 10, 2020
Actual Primary Completion Date : July 20, 2021
Actual Study Completion Date : July 20, 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Eye Diseases

Arm Intervention/treatment
Experimental: AR15512 Ophthalmic Solution (0.0014%)
Low Dose
Drug: AR15512
Administered via topical ocular instillation, one drop per eye, twice daily for 84 days. Both eyes will be treated.

Experimental: AR15512 Ophthalmic Solution (0.003%)
High Dose
Drug: AR15512
Administered via topical ocular instillation, one drop per eye, twice daily for 84 days. Both eyes will be treated.

Placebo Comparator: Vehicle
AR15512 Ophthalmic Solution Vehicle
Drug: Vehicle
Administered via topical ocular instillation, one drop per eye, twice daily for 84 days. Both eyes will be treated.




Primary Outcome Measures :
  1. Ocular Discomfort Score (ODS) on a Visual Analogue Scale (VAS) from 0 (no ocular discomfort) to 100 (maximum ocular discomfort) millimeters [ Time Frame: 28 days ]
    Improvement from baseline in pre-Controlled Adverse Environment (CAE) ODS-VAS where a lower score is indicative of a better outcome.

  2. Anesthetized Schirmer Test from 0 to 35 millimeters [ Time Frame: 28 days ]
    Improvement from baseline in pre-Controlled Adverse Environment (CAE) anesthetized Schirmer score where a higher score is indicative of a better outcome.



Information from the National Library of Medicine

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Ages Eligible for Study:   30 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Male or female, 30 years of age or older at the Screening visit
  • Signs of DED at the Screening and Baseline visits assessed by corneal staining and Schirmer test
  • Symptoms of DED at both Screening and Baseline visits assessed by SANDE questionnaire and ODS-VAS
  • BCVA 20/200 (+0.70 LogMAR) or better in both eyes at both the Screening and Baseline visits

Exclusion Criteria:

  • 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 subject safety.
  • Current evidence of other significant ophthalmic disease requiring topical medication (e.g. glaucoma, ocular hypertension), which may interfere with vision (e.g., cataract, macular degeneration) or other disease which the investigator believes may interfere with study findings or interpretation.
  • History of ocular surgery within 1 year prior to the Screening visit.
  • Corneal transplant in either or both eyes.
  • Use of contact lenses in either eye within 7 days prior to the Screening visit or planned use during the study.
  • Punctal or intracanalicular plug present in either eyelid within 1 year prior to the Screening visit or anticipated plug insertion or occlusion at any time during the study.
  • Use of artificial tears within 2 hours prior to the Screening visit or anticipated use during the study.
  • Regular use of any topical ocular medications (including use of ocular cyclosporine or other prescription ophthalmic solution for DED, topical ocular corticosteroid- or non-steroidal-anti-inflammatory agents, glaucoma medications or other over-the-counter, herbal, prescription, any topical antibiotics, topical antihistamines, mast stabilizers, or nutritional supplements with the exception of artificial tears), within 30 days prior to the Screening visit or anticipated use during the study. Note: Occasional (as needed) >24 hours prior to the Screening Visit may be permitted
  • Use of medications associated with the treatment of severe DED and/or Meibomian gland disease such as oral pilocarpine, oral cevimeline, oral macrolides, oral tetracyclines, oral tetracycline derivatives, and oral retinoids within 90 days prior to the Baseline visit or anticipated use during the study
  • Use of systemic corticosteroids started < 90 days prior to the Baseline Visit or a change in dosage is anticipated during the study. Note: Non-ocular topically applied corticosteroids (including nasal sprays and inhalers) will be permitted during the study and the dose is not required to be stable.
  • Use of TrueTear® within 45 days of the Screening visit or anticipated use during the study.
  • Use of lid heating therapy or Meibomian gland probing/therapeutic expression within 1 year prior to the Screening visit or anticipated during the study.
  • Use of systemic immunomodulators started < 90 days prior to the Baseline visit or a change in dosage is anticipated during the study.
  • Any systemic medication known to cause ocular drying (ex/antihistamines, anti-depressants, beta-blockers) started < 14 days prior to the Screening visit or a change in dosage is anticipated during the study. Note: Occasional (as needed) use of medications such as systemic antihistamines will be permitted
  • 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.
  • History or presence of significant systemic disease.

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): NCT04498182


Locations
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United States, Arizona
Principal Investigator
Phoenix, Arizona, United States, 85032
United States, California
Principal Investigator
Newport Beach, California, United States, 92663
United States, Colorado
Principal Investigator
Colorado Springs, Colorado, United States, 80907
United States, Indiana
Principal Investigator
Carmel, Indiana, United States, 46290
Principal Investigator
Indianapolis, Indiana, United States, 46240
United States, Kentucky
Principal Investigator
Louisville, Kentucky, United States, 40206
United States, Massachusetts
Principal Investigator
Andover, Massachusetts, United States, 01810
Principal Investigator
Raynham, Massachusetts, United States, 02767
United States, Minnesota
Principal Investigator
Hamel, Minnesota, United States, 55340
United States, Missouri
Principal Investigator
Kansas City, Missouri, United States, 64154
United States, North Carolina
Principal Investigator
Shelby, North Carolina, United States, 28150
United States, Tennessee
Principal Investigator
Memphis, Tennessee, United States, 38119
Principal Investigator
Smyrna, Tennessee, United States, 37167
United States, Utah
Principal Investigator
Layton, Utah, United States, 84041
United States, Virginia
Principal Investigator
Lynchburg, Virginia, United States, 24502
Sponsors and Collaborators
Aerie Pharmaceuticals
Investigators
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Study Director: Michelle Senchyna, PhD Aerie Pharmaceuticals
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Responsible Party: Aerie Pharmaceuticals
ClinicalTrials.gov Identifier: NCT04498182    
Other Study ID Numbers: AR15512-CS201
First Posted: August 4, 2020    Key Record Dates
Last Update Posted: July 21, 2022
Last Verified: July 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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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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Dry Eye Syndromes
Keratoconjunctivitis Sicca
Eye Diseases
Lacrimal Apparatus Diseases
Keratoconjunctivitis
Conjunctivitis
Conjunctival Diseases
Keratitis
Corneal Diseases