Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Also known as Apraclonidine Hydrochloride Ophthalmic Solution
Apraclonidine · 3 trials · 2 indications
Ocular redness will be assessed by the investigator and recorded per the Ora Calibra® Ocular Hyperemia Scale, which ranges from 0 to 4 in half-point increments (0.0 = none; 1.0 = mild redness; 2.0 = moderate redness; 3.0 = severe redness; and 4.0 = extremely severe redness). Change from baseline, calculated as post-instillation minus baseline score, can range between -4 and +2.5. Positive values indicate increased ocular redness (worsening), zero indicates no change, and negative values indicate improvement (decrease in severity). This is a co-primary endpoint.
Ocular redness will be assessed by the investigator and recorded per the Ora Calibra® Ocular Hyperemia Scale, which ranges from 0 to 4 in half-point increments (0.0 = none; 1.0 = mild redness; 2.0 = moderate redness; 3.0 = severe redness; and 4.0 = extremely severe redness). Change from baseline, calculated as post-instillation minus baseline score, can range between -4 and +2.5. Positive values indicate increased ocular redness (worsening), zero indicates no change, and negative values indicate improvement (decrease in severity). This is a co-primary endpoint.
Ocular redness will be assessed by the investigator and recorded per the Ora Calibra® Ocular Hyperemia Scale, which ranges from 0 to 4 in half-point increments (0.0 = none; 1.0 = mild redness; 2.0 = moderate redness; 3.0 = severe redness; and 4.0 = extremely severe redness). Change from baseline, calculated as post-instillation minus baseline score, can range between -4 and +2.5. Positive values indicate increased ocular redness (worsening), zero indicates no change, and negative values indicate improvement (decrease in severity). This is a co-primary endpoint.
Ocular redness will be assessed by the investigator and recorded per the Ora Calibra® Ocular Hyperemia Scale, which ranges from 0 to 4 in half-point increments (0.0 = none; 1.0 = mild redness; 2.0 = moderate redness; 3.0 = severe redness; and 4.0 = extremely severe redness). Change from baseline, calculated as post-instillation minus baseline score, can range between -4 and +2.5. Positive values indicate increased ocular redness (worsening), zero indicates no change, and negative values indicate improvement (decrease in severity). This is a co-primary endpoint.
Ocular redness will be assessed by the investigator using a scale from 0 to 4 in half-unit increments (0=none; 4=extremely severe). This endpoint is co-primary with the 10 hours post-instillation endpoint.
Ocular redness will be assessed by the investigator using a scale from 0 to 4 in half-unit increments (0=none; 4=extremely severe). This endpoint is co-primary with the 15 minutes post-instillation endpoint.
| Arm | Type | Description |
|---|---|---|
| Apraclonidine Ophthalmic Solution, 0.125% Unit Dose Preservative Free | EXPERIMENTAL | One drop in each eye on Day 1 (single dose) |
| Vehicle | PLACEBO_COMPARATOR | One drop in each eye on Day 1 (single dose) |
| Apraclonidine Hydrochloride Ophthalmic Solution | EXPERIMENTAL | One drop in each eye on Day 1, followed by 2 drops in each eye on Day 2 onward for approximately 8 weeks |
| Name | Type | Description |
|---|---|---|
| Apraclonidine Ophthalmic Solution, 0.125% Unit Dose Preservative Free | DRUG | Investigational ophthalmic solution applied topically to the eye in a unit dose preservative free (UDPF) formulation |
| Vehicle | DRUG | Inactive ingredients of FID 123472 applied topically to the eye as an ophthalmic solution in a unit dose preservative free (UDPF) formulation |
| Apraclonidine Hydrochloride Ophthalmic Solution | DRUG | Investigational ophthalmic solution applied topically to the eye with a dropper bottle |
Key Inclusion Criteria: * Capable of giving signed informed consent and comply with the requirements listed in the Informed Consent Form. * Willing and able to follow all instructions and attend all study visits. * History of redness relief eyedrop use within the last 6 months, or an interest in us...
Apraclonidine is being developed as an ophthalmic solution for reducing ocular hyperemia, commonly called ocular redness, in adults. Alcon Inc. is studying a 0.125% unit dose preservative free formulation in Phase 3 trials in the United States. It is an investigational eye drop, not an approved treatment for this use.
Apraclonidine is an agonist of the alpha-2 adrenergic receptors ADRA2A, ADRA2B, and ADRA2C. By activating these receptors, the small molecule acts on adrenergic signaling in the eye. This receptor agonist activity is the basis for its development as a topical ophthalmic solution for ocular redness.
Alcon Inc., which trades under the ticker ALC, is developing apraclonidine as a 0.125% unit dose preservative free ophthalmic solution for ocular hyperemia and ocular redness. The program is in Phase 3 clinical development, with trials running in the United States.
Apraclonidine ophthalmic solution is in Phase 3 clinical development for ocular hyperemia and ocular redness. It is investigational and has not been established as an approved therapy for these indications. The Phase 3 program includes randomized, double-blind, placebo-controlled trials in adults aged 18 years and older.
Two Phase 3 trials of apraclonidine ophthalmic solution are currently recruiting adults with ocular hyperemia in the United States: NCT07578363, with planned enrollment of 178 participants, and NCT07531043, with planned enrollment of 230. A completed Phase 3 study, NCT06444529, enrolled 159 participants with ocular redness.
Yes. Apraclonidine is also referred to as apraclonidine hydrochloride ophthalmic solution, apraclonidine ophthalmic solution, and apraclonidine 0.125% unit dose preservative free. These names describe the same small molecule developed by Alcon Inc. as a topical eye drop for ocular redness and ocular hyperemia.