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

Sponsor

Aerie Pharmaceuticals (Industry)

Overall Status

Completed

CT.gov ID

NCT04498182

Collaborator

(none)

369

Enrollment

Locations

Arms

8.3

Actual Duration (Months)

24.6

Patients Per Site

Patients Per Site Per Month

Study Details

Study Description

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

Study Design

Study Type:

Interventional

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 vehicleSubjects 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 :

Nov 10, 2020

Actual Primary Completion Date :

Jul 20, 2021

Actual Study Completion Date :

Jul 20, 2021

Arms and Interventions

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.

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.

Outcome Measures

Primary Outcome Measures

Ocular Discomfort Score (ODS) on a Visual Analogue Scale (VAS) from 0 (no ocular discomfort) to 100 (maximum ocular discomfort) millimeters [28 days]
Improvement from baseline in pre-Controlled Adverse Environment (CAE) ODS-VAS where a lower score is indicative of a better outcome.
Anesthetized Schirmer Test from 0 to 35 millimeters [28 days]
Improvement from baseline in pre-Controlled Adverse Environment (CAE) anesthetized Schirmer score where a higher score is indicative of a better outcome.

Eligibility Criteria

Criteria

Ages Eligible for Study:

30 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Principal Investigator	Phoenix	Arizona	United States	85032
2	Principal Investigator	Newport Beach	California	United States	92663
3	Principal Investigator	Colorado Springs	Colorado	United States	80907
4	Principal Investigator	Carmel	Indiana	United States	46290
5	Principal Investigator	Indianapolis	Indiana	United States	46240
6	Principal Investigator	Louisville	Kentucky	United States	40206
7	Principal Investigator	Andover	Massachusetts	United States	01810
8	Principal Investigator	Raynham	Massachusetts	United States	02767
9	Principal Investigator	Hamel	Minnesota	United States	55340
10	Principal Investigator	Kansas City	Missouri	United States	64154
11	Principal Investigator	Shelby	North Carolina	United States	28150
12	Principal Investigator	Memphis	Tennessee	United States	38119
13	Principal Investigator	Smyrna	Tennessee	United States	37167
14	Principal Investigator	Layton	Utah	United States	84041
15	Principal Investigator	Lynchburg	Virginia	United States	24502

Sponsors and Collaborators

Aerie Pharmaceuticals

Investigators

Study Director: Michelle Senchyna, PhD, Aerie Pharmaceuticals

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Aerie Pharmaceuticals

ClinicalTrials.gov Identifier:

NCT04498182

Other Study ID Numbers:

AR15512-CS201

First Posted:

Aug 4, 2020

Last Update Posted:

Jul 21, 2022

Last Verified:

Jul 1, 2022

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Yes

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Dry Eye Syndromes

Keratoconjunctivitis Sicca

Eye Diseases

Study Results

No Results Posted as of Jul 21, 2022