Dry Eye Disease Clinical Trial
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)
Verified date | October 2023 |
Source | Aerie Pharmaceuticals |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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).
Status | Completed |
Enrollment | 467 |
Est. completion date | October 17, 2023 |
Est. primary completion date | October 17, 2023 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 30 Years and older |
Eligibility | 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) |
Country | Name | City | State |
---|---|---|---|
United States | Andover Eye Associates - Andover | Andover | Massachusetts |
United States | Keystone Research | Austin | Texas |
United States | Argus Research Center | Cape Coral | Florida |
United States | Reeve Woods Eye Center | Chico | California |
United States | Pankratz Eye Institute | Columbus | Indiana |
United States | Axis Clinicals | Dallas | Texas |
United States | Erie Retina Research | Erie | Pennsylvania |
United States | NVision Clinical Research - Fullerton | Fullerton | California |
United States | Oculus Research | Garner | North Carolina |
United States | NVision Clinical Research - La Mesa | La Mesa | California |
United States | Jacksoneye, S.C. | Lake Villa | Illinois |
United States | AdvanceMed Clinical Research | Las Vegas | Nevada |
United States | Wilmington Eye | Leland | North Carolina |
United States | Piedmont Eye Center | Lynchburg | Virginia |
United States | Boston Vision | Milford | Massachusetts |
United States | Pure Ophthalmic Research | Mint Hill | North Carolina |
United States | Eye Research Foundation | Newport Beach | California |
United States | Wyse Eyecare | Northbrook | Illinois |
United States | Schultz Chang Vision | Northridge | California |
United States | Andover Eye Associates - Raynham | Raynham | Massachusetts |
United States | Virginia Eye Institute | Richmond | Virginia |
United States | NVision Clinical Research - Torrance | Torrance | California |
United States | Andover Eye Associates | Warwick | Rhode Island |
Lead Sponsor | Collaborator |
---|---|
Aerie Pharmaceuticals |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Unanesthetized Schirmer test | 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. |
Day 14 | |
Secondary | SANDE (Symptom Assessment iN Dry Eye) Questionnaire Score | 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. |
Day 28 | |
Secondary | SANDE (Symptom Assessment iN Dry Eye) Questionnaire Score | 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. |
Day 7, 14, 90 | |
Secondary | Unanesthetized Schirmer score | 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. |
Day 7, 14, 28 & 90 | |
Secondary | Ocular Discomfort Score (ODS) - VAS | 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. |
Day 28 & 90 | |
Secondary | Eye Dryness Score (EDS) - VAS | 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. |
Day 28 & 90 | |
Secondary | Unanesthetized Schirmer score | 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. |
Day 7, 28 & 90 | |
Secondary | Quality of Life VAS | 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. |
Day 7, 14, 28 & 90 | |
Secondary | Ocular Pain - VAS | 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. |
Day 90 | |
Secondary | Conjunctival Redness | 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. |
Day 90 |
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