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Trial record 2 of 5 for:    AR-15512

Study Evaluating the Safety and Efficacy of AR-15512 (COMET-3)

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ClinicalTrials.gov Identifier: NCT05360966
Recruitment Status : Recruiting
First Posted : May 4, 2022
Last Update Posted : January 19, 2023
Sponsor:
Information provided by (Responsible Party):
Aerie Pharmaceuticals

Brief Summary:
This will be a Phase 3, multicenter, vehicle-controlled, double-masked, randomized study conducted at approximately 20 sites in the United States. All subjects enrolled will have dry eye disease (DED). The study will consist of Screening (Day -14) and Baseline (Day 1) visits as well as visits at Day 7, Day 14, Day 28, and Day 90 (Study Exit).

Condition or disease Intervention/treatment Phase
Dry Eye Disease Drug: AR-15512 Ophthalmic Solution Drug: Vehicle Phase 3

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 460 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Qualified subjects will be enrolled in the study and randomized in a 1:1 ratio within each site to receive 0.003% AR 15512 or AR-15512 vehicle to be administered twice daily (BID) as 1 drop in each eye for 90 days.
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.
Primary Purpose: Treatment
Official Title: A Phase 3 Study Evaluating the Safety and Efficacy of AR-15512, a Cold Thermoreceptor Modulator, for the Treatment of Dry Eye Disease (COMET-3)
Actual Study Start Date : July 18, 2022
Estimated Primary Completion Date : May 2023
Estimated Study Completion Date : May 2023

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Eye Diseases

Arm Intervention/treatment
Experimental: AR-15512 Ophthalmic Solution (0.003%)
0.003% AR-15512 to be administered BID for 90 days. Both eyes will be treated.
Drug: AR-15512 Ophthalmic Solution
Topical ocular administration of one drop in both eyes BID for 90 days.

Placebo Comparator: Vehicle
AR-15512 vehicle to be administered BID for 90 days. Both eyes will be treated.
Drug: Vehicle
Topical ocular administration of one drop in both eyes BID for 90 days.




Primary Outcome Measures :
  1. Unanesthetized Schirmer test [ Time Frame: Day 14 ]

    Proportion of subjects ≥ 10 mm increase in unanesthetized Schirmer score.

    Schirmer strips placed, without anesthesia, in both eyes measure the amount of tear wetting over a 5-minute period, in whole millimeters to a maximum score of 35 mm. An ≥ 10 mm score over time indicates a better outcome.



Secondary Outcome Measures :
  1. SANDE (Symptom Assessment iN Dry Eye) Questionnaire Score [ Time Frame: Day 28 ]

    Change from Baseline in SANDE score.

    The SANDE questionnaire consists of two visual analogue scales (VAS), each ranging from 0mm to 100mm to indicate the frequency (from "Rarely" to "All the Time") and severity (from "Very Mild" to "Very Severe") of dry eye symptoms. A higher score indicates greater frequency or severity. Each subject marks both VAS to indicate their level of frequency and severity. The SANDE score is calculated by multiplying the frequency score by the severity score and obtaining the square root. A reduced SANDE score over time indicates a better outcome.


  2. SANDE (Symptom Assessment iN Dry Eye) Questionnaire Score [ Time Frame: Day 7, 14, 90 ]

    Change from Baseline in SANDE score.

    The SANDE questionnaire consists of two visual analogue scales (VAS), each ranging from 0mm to 100mm to indicate the frequency (from "Rarely" to "All the Time") and severity (from "Very Mild" to "Very Severe") of dry eye symptoms. A higher score indicates greater frequency or severity. Each subject marks both VAS to indicate their level of frequency and severity. The SANDE score is calculated by multiplying the frequency score by the severity score and obtaining the square root. A reduced SANDE score over time indicates a better outcome.


  3. Unanesthetized Schirmer score [ Time Frame: Day 7, 14, 28 & 90 ]

    Change from Baseline

    Schirmer strips placed, without anesthesia, in both eyes measure the amount of tear wetting over a 5-minute period, in whole millimeters to a maximum score of 35 mm. An increased score over time indicates a better outcome.


  4. Ocular Discomfort Score (ODS) - VAS [ Time Frame: Day 28 & 90 ]

    Change from Baseline

    Subjects mark a visual analogue scale (VAS) between 0mm to 100mm to indicate (from "no symptom" to "maximal symptom") their ocular discomfort. A reduced score over time indicates a better outcome.


  5. Eye Dryness Score (EDS) - VAS [ Time Frame: Day 28 & 90 ]

    Change from Baseline

    Subjects mark a visual analogue scale (VAS) between 0mm to 100mm to indicate (from "no symptom" to "maximal symptom") their eye dryness. A reduced score over time indicates a better outcome.


  6. Unanesthetized Schirmer score [ Time Frame: Day 7, 28 & 90 ]

    Proportion of subjects with ≥ 10 mm increase in score

    Schirmer strips placed, without anesthesia, in both eyes measure the amount of tear wetting over a 5-minute period, in whole millimeters to a maximum score of 35 mm. An ≥ 10 mm score over time indicates a better outcome.


  7. Quality of Life VAS [ Time Frame: Day 7, 14, 28 & 90 ]

    Change from Baseline

    Subjects mark a visual analogue scale (VAS) between 0mm to 100mm to indicate (from "strongly disagree" to "strongly agree") their agreement with the statement "Over the past 3 days my dry eye has interfered with my daily activities and reduced my quality of life". A reduced score over time indicates a better outcome.


  8. Ocular Pain - VAS [ Time Frame: Day 90 ]

    Change from Baseline

    Subjects mark a visual analogue scale (VAS) between 0mm to 100mm to indicate (from "no symptom" to "maximal symptom") their ocular discomfort. A reduced score over time indicates a better outcome.


  9. Conjunctival Redness [ Time Frame: Day 90 ]

    Change from Baseline

    Investigators or designated sub-Investigators grade redness of the eye on a scale from 0 to 4 (from 0 "normal" to 4 "severe"). A reduced score over time indicates a better outcome.




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:   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
  • Corrected visual acuity (+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
  • Regular use of lid hygiene within 14 days prior to the Screening visit or any planned use during the study
  • Use of artificial tears within 2 hours prior to the Screening visit or anticipated use during the study
  • Use of any topical ocular anti-inflammatory medication within 30 days prior to the Screening visit or anticipated use during the study (e.g., ocular cyclosporine [Restasis®, Cequa™], lifitegrast [Xiidra®], or any other prescription ophthalmic product for DED, topical ocular corticosteroid- or non-steroidal-anti-inflammatory agents
  • Use of Tyrvaya™ (varenicline solution, nasal spray 0.03mg) within 30 days prior to the Screening visit or anticipated use during the study
  • Use of medications for 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 30 days prior to the Screening visit or anticipated use during the study.
  • Initiation, discontinuation, or change in dose of a systemic medication known to cause ocular drying (e.g., antihistamines or tricyclic antidepressants) less than 14 days prior to the Screening visit or a change in dosage is anticipated during the study.
  • Initiation, discontinuation, or change in dose of a systemic corticosteroid less than 60 days prior to the Screening visit or a change in dosage is anticipated during the study.
  • Initiation, discontinuation, or change in dose of a systemic immunomodulator (e.g., hydroxychloroquine, methotrexate, cyclosporine) less than 60 days prior to the Screening visit or a change in dosage is anticipated during the study
  • History or presence of significant systemic disease (i.e.: cardiovascular, pulmonary, hepatic, renal, hematologic, immunologic)

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): NCT05360966


Contacts
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Contact: Antoinette Brown 949-526-8708 COMET-3@aeriepharma.com
Contact: Raul Ramos 908-440-0086 COMET-3@aeriepharma.com

Locations
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United States, California
Eye Research Foundation Recruiting
Newport Beach, California, United States, 92663
United States, Florida
Argus Research Center Not yet recruiting
Cape Coral, Florida, United States, 33904
United States, Illinois
Jacksoneye, S.C. Not yet recruiting
Lake Villa, Illinois, United States, 60046
United States, Indiana
Pankratz Eye Institute Recruiting
Columbus, Indiana, United States, 47203
United States, Massachusetts
Andover Eye Associates - Andover Recruiting
Andover, Massachusetts, United States, 01810
Andover Eye Associates - Raynham Recruiting
Raynham, Massachusetts, United States, 02767
United States, North Carolina
Wilmington Eye Not yet recruiting
Leland, North Carolina, United States, 28451
Pure Ophthalmic Research Recruiting
Mint Hill, North Carolina, United States, 28227
United States, Rhode Island
Andover Eye Associates Recruiting
Warwick, Rhode Island, United States, 02886
United States, Virginia
Piedmont Eye Center Not yet recruiting
Lynchburg, Virginia, United States, 24502
Virginia Eye Institute Recruiting
Richmond, Virginia, United States, 23230
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: NCT05360966    
Other Study ID Numbers: AR-15512-CS302
First Posted: May 4, 2022    Key Record Dates
Last Update Posted: January 19, 2023
Last Verified: January 2023
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
Ophthalmic Solutions
Pharmaceutical Solutions