NCT06660290

A Study to Evaluate 0.003% AR-15512 Safety and Drop Attributes

A Phase 3b Study to Evaluate 0.003% AR-15512 Safety and Drop Attributes

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 55 (actual)
• Sponsor: Alcon Research · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to evaluate the percentage of ocular adverse events reported in subjects with dry eye disease (DED) between the intervention arm (0.003% AR-15512) and control arm (REFRESH® Classic).

Detailed description

Subjects will be randomized to one of four sequences of 0.003% AR-15512 ophthalmic solution instillation variations which will be administered after administration of control (REFRESH® Classic). This is a 1-visit study (Screening, Enrollment, Assessments).

Conditions

• Dry Eye Disease

Interventions

Type	Name	Description
DRUG	0.003% AR-15512 ophthalmic solution	Investigational ophthalmic solution administered topically in 4 different instillation variations: 512-RT (0.003% AR-15512 instilled at room temperature, eyes to remain open post-drop instillation); 512-COLD (0.003% AR-15512 stored in refrigerator and instilled immediately after removal from refrigerator, eyes to remain open post-drop instillation); 512-RT-EC (0.003% AR-15512 instilled at room temperature followed by subjects immediately closing their eyes); and 512-COLD-EC (0.003% AR-15512 stored in refrigerator and instilled immediately after removal from refrigerator followed by subjects immediately closing their eyes).
DRUG	Artificial tears	Commercially available, preservative-free lubricant eye drops administered topically

Timeline

• Start date: 2025-01-15
• Primary completion: 2025-02-06
• Completion: 2025-02-06
• First posted: 2024-10-28
• Last updated: 2026-03-17
• Results posted: 2026-03-17

Locations

6 sites across 1 country: United States

Regulatory

• FDA-regulated drug study