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Also known as Apraclonidine, 0.125% Unit Dose Preservative Free
Apraclonidine · 1 trial · 1 indication
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 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 |
| Vehicle | PLACEBO_COMPARATOR | 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 Hydrochloride Ophthalmic Solution | DRUG | Investigational ophthalmic solution applied topically to the eye with a dropper bottle |
| Vehicle | DRUG | Vehicle (inactive ingredients) applied topically to the eye with a dropper bottle |
Key Inclusion Criteria: * Capable of giving signed informed consent; * Willing and able to follow all instructions and attend all study visits; * Able to self-administer eye drops- in the opinion of the investigator; * History of redness relief drop use within the last 6 months, or a desire to use ...
Apraclonidine is used for the reduction of ocular redness. It is an ophthalmic solution being developed as a treatment for ocular redness, a condition characterized by red or bloodshot eyes. The drug is administered as eye drops and is intended to address the cosmetic and symptomatic aspects of eye redness.
Apraclonidine is a small molecule that acts as an alpha-2 adrenergic receptor agonist. By stimulating these receptors, it causes vasoconstriction of the conjunctival blood vessels, which reduces the appearance of redness in the eyes. This mechanism is specific to the ophthalmic application for ocular redness.
Apraclonidine is being developed by Alcon Inc., a pharmaceutical company specializing in eye care. Alcon is publicly traded under the ticker symbol ALC. The company is conducting clinical trials to evaluate the safety and efficacy of Apraclonidine for the treatment of ocular redness.
Apraclonidine is in Phase 3 clinical development. It is an investigational drug, meaning it has not yet been approved by regulatory authorities. The Phase 3 trial has been completed, and the results will be used to support a potential regulatory submission for approval.
Apraclonidine has been studied in one clinical trial registered as NCT06444529. This was a Phase 3, double-masked, placebo-controlled study titled 'A Double-Masked Comparison of FID 123320 Ophthalmic Solution to Vehicle for the Reduction of Ocular Redness.' The trial enrolled 159 participants in the United States and has been completed.
Yes, Apraclonidine is also known as Apraclonidine Ophthalmic Solution, 0.125% Unit Dose Preservative Free. This formulation is specifically designed for the reduction of ocular redness. The drug is sometimes referred to by its alternative names, but they all refer to the same active ingredient and product.