A Long-Term Safety Study Evaluating the Safety and Systemic Exposure of AR-15512

• Status: Not yet recruiting
• Trial end date: 2024-02-28
• Target enrollment: 0
• Participant gender: All

Summary

This will be a 12-month, multicenter, vehicle-controlled, double-masked, randomized Phase 3 study conducted at approximately 10 sites in the United States. All subjects enrolled will have dry eye disease (DED). The study will consist of a Baseline (Day 1) visit as well as visits at Day 14, Day 90, Day 180, Day 270, and Day 365 (Study Exit).

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Aerie Pharmaceuticals
• Treatments: Ophthalmic Solutions

Criteria

Key Inclusion Criteria:

• Male or female, 18 years of age or older at baseline visit

• Have a previous history of DED, clinician diagnosed or patient reported, within the previous 12 months of the Baseline visit

• Have used or desired to use artificial tears for DED symptoms within 3 months prior to the Baseline visit

• Have a documented Schirmer test with or without topical anesthesia score ≥ 2 and < 10 mm/5 min in at least one eye within 1 year prior to the Baseline visit

• Total ocular surface staining score of ≥ 1 and ≤ 12 and no region = 5, based on the Oxford grading scheme at the Baseline visit

• Corrected visual acuity equal to or better than logMar +0.7 (Snellen equivalent equal to or better than 20/100), as assessed by Early Treatment of Diabetic Retinopathy Study (ETDRS) scale in both eyes at the Baseline visit

• Good general and ocular health, as determined by the investigator using medical history, ophthalmic examination and history, and vital signs (heart rate and blood pressure) at the Baseline visit

Key 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

• Use of contact lenses in either eye within 7 days prior to the Baseline visit or planned use during the study

• Use of any topical ocular anti-inflammatory medication within 30 days prior to the Baseline 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 topical ocular autologous serum within 30 days prior to the Baseline visit or anticipated use during the study

• Use of any topical ocular glaucoma medication within 30 days prior to the Baseline visit or anticipated use during the study

• Use of Tyrvara™ (varenicline solution, nasal spray 0.03mg) within 30 days prior to the Baseline 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 Baseline visit or anticipated use during the study

• Use of lid heating therapy (i.e., LipiFlow®, iLUX®) or Meibomian gland probing/therapeutic expression within 6 months prior to the Baseline visit or anticipated during the study