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Also known as 0.003% AR-15512 ophthalmic solution
0.003% AR-15512 · 3 trials · 1 indication
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.
TMH (the distance between the line of reflection along the top of the tear prism to the edge of the central lower eyelid) was measured pre-instillation and post-instillation in micrometers using optical coherence tomography (OCT), a non-invasive imaging test that uses light waves to take cross-section pictures of the eye. A normal TMH range falls between 200 and 400 micrometers. Measurements below this range may indicate dry eye disease. A positive change value indicates an improvement. One eye (study eye, defined as the left eye) contributed data to the analysis.
TMH (the distance between the line of reflection along the top of the tear prism to the edge of the central lower eyelid) was measured pre-instillation and post-instillation in micrometers using optical coherence tomography (OCT), a non-invasive imaging test that uses light waves to take cross-section pictures of the eye. A normal TMH range falls between 200 and 400 micrometers. Measurements below this range may indicate dry eye disease. A positive change value indicates an improvement. One eye (study eye, defined as the left eye) contributed data to the analysis.
Goblet cells are specialized epithelial cells that secrete mucins onto the ocular surface to help hydrate and lubricate the eye surface. Samples of conjunctiva were collected on filter papers based on a technique called impression cytology. The filter papers were then processed in a lab to measure the number of goblet cells (cells/mm2). The percent change in goblet cell density at Day 90 compared to Day 1 (Baseline) was calculated. A positive change value indicates an improvement. Only one eye (study eye) contributed data to the analysis. This outcome measure was pre-specified for 0.003% AR-15512 arm only.
| Arm | Type | Description |
|---|---|---|
| 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. |
| 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. |
| 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. |
| 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. |
| 0.003% AR-15512 | EXPERIMENTAL | One drop of 0.003% AR-15512 ophthalmic solution in each eye in a staggered cadence (left eye followed by dosing of the right eye, separated by approximately 2-4 hours) |
| Artificial Tears | ACTIVE_COMPARATOR | One drop of artificial tears in each eye twice daily for 90 days (treatment period) |
| Name | Type | Description |
|---|---|---|
| 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). |
| Artificial tears | DRUG | Commercially available, preservative-free lubricant eye drops administered topically |
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 c...
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0.003% AR-15512 is an investigational small molecule ophthalmic solution being developed for Dry Eye Disease. It is a Phase 3 clinical-stage candidate. Alcon Inc. (ticker ALC) is the developer. It is not yet approved and remains under clinical development.
0.003% AR-15512 is being studied for the treatment of Dry Eye Disease. All three of its Phase 3 trials enrolled adults 18 years and older with Dry Eye Disease in the United States. It is investigational and has not been approved for any indication.
Alcon Inc., which trades under the ticker ALC, is the developer of 0.003% AR-15512. The company is advancing the ophthalmic solution as a Phase 3 candidate for Dry Eye Disease. Alcon is an eye care company focused on ophthalmology and vision care products.
0.003% AR-15512 is in Phase 3 development for Dry Eye Disease. Three Phase 3 trials have been completed, and none are currently active. The program has enrolled 216 participants in total across those completed studies. The drug remains investigational and is not FDA approved.
Three completed Phase 3 trials have evaluated 0.003% AR-15512 in Dry Eye Disease: NCT06660290, which assessed safety and drop attributes in 55 participants; NCT06544707, which evaluated tear production in 81 participants; and NCT06544694, which investigated the effect on subjects with Dry Eye Disease in 80 participants. All were conducted in the United States.
Yes, 0.003% AR-15512 ophthalmic solution is another name for 0.003% AR-15512. Both refer to the same investigational small molecule eye drop developed by Alcon Inc. (ticker ALC) for Dry Eye Disease. The two names describe the same Phase 3 asset.