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

NCT06660290 | Completed Phase 3 Results FDA Drug

• 1 other identifier: DEF512-E005
• Study Type: interventional
• Target: 55
• Locations: 1 country
• Sites: 6

Brief 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).

Conditions

Dry Eye Disease

Keywords

Dry Eyes

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (4)

Sequence 1

OTHER

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; Drug: Artificial tears

Sequence 2

OTHER

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; Drug: Artificial tears

Sequence 3

OTHER

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; Drug: Artificial tears

Sequence 4

OTHER

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; Drug: Artificial tears

Interventions

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).

Also known as: TRYPTYR®, Acoltremon ophthalmic solution 0.003%

Sequence 1; Sequence 2; Sequence 3; Sequence 4

Artificial tears DRUG

Commercially available, preservative-free lubricant eye drops administered topically

Also known as: REFRESH® Classic

Sequence 1; Sequence 2; Sequence 3; Sequence 4

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Alcon Research: lead

Study Sites (6)

Eye Research Foundation

Newport Beach, California, 92663, United States

Location

Vision Institute

Colorado Springs, Colorado, 80907, United States

Location

Andover Eye Associates

Andover, Massachusetts, 01810, United States

Location

Total Eye Care, PA

Memphis, Tennessee, 38119, United States

Location

Advancing Vision Research, LLC

Smyrna, Tennessee, 37167, United States

Location

Piedmont Eye Center

Lynchburg, Virginia, 24502, United States

Location

MeSH Terms

Conditions

Dry Eye Syndromes

Interventions

Lubricant Eye Drops

Condition Hierarchy (Ancestors)

Lacrimal Apparatus Diseases; Eye Diseases

Intervention Hierarchy (Ancestors)

Ophthalmic Solutions; Pharmaceutical Solutions; Solutions; Pharmaceutical Preparations; Therapeutic Uses; Pharmacologic Actions; Chemical Actions and Uses; Lubricants; Specialty Uses of Chemicals

Results Point of Contact

• Title: Scientific Advisor, Clinical Research and Development
• Organization: Alcon Research, LLC

alcon.medinfo@alcon.com

1-888-451-3937

Study Officials

• Sr. Clinical Trial Lead, Pharma

  Alcon Research, LLC

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 24, 2024
• First Posted: October 28, 2024
• Study Start: January 15, 2025
• Primary Completion: February 6, 2025
• Study Completion: February 6, 2025
• Last Updated: March 17, 2026
• Results First Posted: March 17, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (6)