A 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).

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Key information

Conditions

Dry Eye Disease Dry Eye Syndromes Eye Diseases Lacrimal Apparatus Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Eye Research Foundation, Newport Beach, California, United States

About this study

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).

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

0.003% AR-15512 ophthalmic solution

Drug

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%

Artificial Tears

Drug

Commercially available, preservative-free lubricant eye drops administered topically

Other names: REFRESH® Classic

Primary outcomes

Percentage of Subjects With Ocular Treatment-Emergent Adverse Events Attributed to Study Intervention

Time frame: Up to Day 1 post drop instillation

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.

Sponsors and collaborators

Lead sponsor

Alcon Research

Industry

Registry information

Official study title

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

Important dates

Study start: 2025
Primary completion: 2025
Study completion: 2025
First posted: Oct 28, 2024
Registry last updated: Mar 17, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed