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

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).

Study Overview

• Status: Completed
• Conditions: Dry Eye Disease
• Intervention / Treatment: Drug: 0.003% AR-15512 ophthalmic solution; Drug: Artificial tears

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).

• Study Type: Interventional
• Enrollment (Actual): 55
• Phase: Phase 3

Contacts and Locations

Study Locations

• United States
  • California
    • Newport Beach, California, United States, 92663
      • Eye Research Foundation
  • Colorado
    • Colorado Springs, Colorado, United States, 80907
      • Vision Institute
  • Massachusetts
    • Andover, Massachusetts, United States, 01810
      • Andover Eye Associates
  • Tennessee
    • Memphis, Tennessee, United States, 38119
      • Total Eye Care, PA
    • Smyrna, Tennessee, United States, 37167
      • Advancing Vision Research, LLC
  • Virginia
    • Lynchburg, Virginia, United States, 24502
      • Piedmont Eye Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Key Inclusion Criteria:

• Corrected Visual Acuity (Snellen) 20/200 or better in both eyes;
• Good general and ocular health, as determined by the Investigator using medical history, ophthalmic examination and history;
• Capable of giving signed informed consent.
• Other protocol-defined inclusion criteria may apply.

Key Exclusion Criteria:

• Current evidence of other clinically significant ophthalmic disease other than dry eye;
• History of ocular surgery within 1 year of the Study Visit;
• Use of any topical ocular anti-inflammatory medications (for example, Restasis®, Cequa™, Vevye™, Xiidra®), other prescription ophthalmic product for dry eyes, topical ocular corticosteroid, or non-steroidal-anti-inflammatory agents within 30 days of the Study Visit;
• Positive pregnancy test or currently breastfeeding.
• Other protocol-defined exclusion criteria may apply.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Single

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: Sequence 1; One drop of artificial tears in the right eye, followed by 0.003% AR-15512 ophthalmic solution in four different instillation variations: 512-RT, then 512-COLD, followed by 512-RT-EC, and finally 512-COLD-EC. Each instillation consisted of 1 drop in 1 eye only starting with the left eye and alternating the eyes thereafter. Protocol-specified wait periods separated each instillation.	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).; Other Names: TRYPTYR®; Acoltremon ophthalmic solution 0.003%; Drug: Artificial tears; Commercially available, preservative-free lubricant eye drops administered topically; Other Names: REFRESH® Classic
Other: Sequence 2; One drop of artificial tears in the right eye, followed by 0.003% AR-15512 ophthalmic solution in four different instillation variations: 512-RT-EC, then 512-RT, followed by 512-COLD-EC, and finally 512-COLD. Each instillation consisted of 1 drop in 1 eye only starting with the left eye and alternating the eyes thereafter. Protocol-specified wait periods separated each instillation.	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).; Other Names: TRYPTYR®; Acoltremon ophthalmic solution 0.003%; Drug: Artificial tears; Commercially available, preservative-free lubricant eye drops administered topically; Other Names: REFRESH® Classic
Other: Sequence 3; One drop of artificial tears in the right eye, followed by 0.003% AR-15512 ophthalmic solution in four different instillation variations: 512-COLD, then 512-COLD-EC, followed by 512-RT, and finally 512-RT-EC. Each instillation consisted of 1 drop in 1 eye only starting with the left eye and alternating the eyes thereafter. Protocol-specified wait periods separated each instillation.	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).; Other Names: TRYPTYR®; Acoltremon ophthalmic solution 0.003%; Drug: Artificial tears; Commercially available, preservative-free lubricant eye drops administered topically; Other Names: REFRESH® Classic
Other: Sequence 4; One drop of artificial tears in the right eye, followed by 0.003% AR-15512 ophthalmic solution in four different instillation variations: 512-COLD-EC, then 512-RT-EC, followed by 512-COLD, and finally 512-RT. Each instillation consisted of 1 drop in 1 eye only starting with the left eye and alternating the eyes thereafter. Protocol-specified wait periods separated each instillation.	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).; Other Names: TRYPTYR®; Acoltremon ophthalmic solution 0.003%; Drug: Artificial tears; Commercially available, preservative-free lubricant eye drops administered topically; Other Names: REFRESH® Classic

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Percentage of Subjects With Ocular Treatment-Emergent Adverse Events Attributed to Study Intervention	Treatment-emergent adverse events (TEAEs) were defined as any event that occurred or worsened on or after the day that study intervention was initiated. No hypothesis testing was prespecified for this endpoint.	Up to Day 1 post drop instillation

Collaborators and Investigators

• Sponsor: Alcon Research
• Investigators: Study Director: Sr. Clinical Trial Lead, Pharma, Alcon Research, LLC

Study record dates

Study Major Dates

• Study Start (Actual): January 15, 2025
• Primary Completion (Actual): February 6, 2025
• Study Completion (Actual): February 6, 2025

Study Registration Dates

• First Submitted: October 24, 2024
• First Submitted That Met QC Criteria: October 25, 2024
• First Posted (Actual): October 28, 2024

Study Record Updates

• Last Update Posted (Actual): March 17, 2026
• Last Update Submitted That Met QC Criteria: March 13, 2026
• Last Verified: March 1, 2026

More Information

Terms related to this study

• Keywords: Dry Eyes
• Additional Relevant MeSH Terms: Eye Diseases; Lacrimal Apparatus Diseases; Dry Eye Syndromes; Ophthalmic Solutions; Pharmaceutical Solutions; Pharmaceutical Preparations; Pharmacologic Actions; Chemical Actions and Uses; Therapeutic Uses; Solutions; Specialty Uses of Chemicals; Lubricants; Lubricant Eye Drops
• Other Study ID Numbers: DEF512-E005

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No