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Label indication ALPHAGAN P (brimonidine tartrate ophthalmic solution) 0.1% or 0.15% is indicated for the reduction of elevated intraocular pressure (IOP) in patients with open-angle glaucoma or ocular hypertension. ALPHAGAN P is an alpha adrenergic agonist indicated for the reduction of elevated intraocular pressure (IOP) in patients with open-angle glaucoma or ocular hypertension. ( 1 ) FDA label
Also known as Brimonidine tartrate
Brimonidine · 3 trials · 1 indication
TEAE is defined as any untoward medical occurrence or undesirable event(s) that begins or worsens following administration of the study drug, whether or not considered related to the treatment by the Investigator. A TEAE is considered serious if, in the view of the Investigator or Sponsor, it results in any of the following outcomes: death, a life-threatening TEAE, inpatient hospitalization or prolongation of existing hospitalization, persistent or significant disability or incapacity, a congenital anomaly or birth defect, an important medical event that jeopardized the participant and required medical intervention, or sight-threatening (possibly resulting in persistent or significant loss of vision). A summary of other non-serious adverse events (AEs) and all serious AEs, regardless of causality is located in Reported AE section.
Ocular redness using the Ora Calibra Ocular Hyperemia Scale was scored by the Investigator using the following scale (allowing half unit increments): 0=None; 1.0=Mild-Slightly dilated blood vessels, color of vessels is typically pink, can be quadrantal; 2.0=Moderate-More apparent dilation of blood vessels, vessel color is more intense (redder), involves the majority of the vessel bed; 3.0=Severe-Numerous and obvious dilated blood vessels, in the absence of chemosis the color is deep red, may be less red or pink in presence of chemosis, is not quadrantic; 4.0=Extremely Severe-Large, numerous, dilated blood vessels characterized by unusually severe deep red color, regardless of grade of chemosis, which involves the entire vessel bed. A lower score is indicative of less redness.
Blood samples will be collected for the determination of brimonidine in plasma at the specified time points on Day 1.
| Arm | Type | Description |
|---|---|---|
| Brimonidine Tartrate | EXPERIMENTAL | Participants will apply 1 drop of brimonidine tartrate ophthalmic solution 0.025% into each eye 4 times daily for up to 4 consecutive weeks. |
| Brimonidine Tartrate Vehicle | PLACEBO_COMPARATOR | Participants will apply 1 drop of the vehicle of brimonidine tartrate ophthalmic solution into each eye 4 times daily for up to 4 consecutive weeks. |
| Name | Type | Description |
|---|---|---|
| Brimonidine Tartrate | DRUG | Ophthalmic solution to be applied as directed. |
| Vehicle | DRUG | Ophthalmic solution to be applied as directed. |
| Sodium Fluorescein | DRUG | For use as needed during the study for evaluating corneal damage. |
| Fluorescein Sodium and Benoximate Hydrocholoride Ophthalmic Solution USP | DRUG | For use as needed during the study for intraocular pressure and dilated ophthalmoscopy. |
Inclusion Criteria: * Participants must be at least 5 years of age at Baseline (Visit 1) of either sex and any race or ethnicity; * Have ocular health within normal limits, including a calculated best-corrected (if necessary) visual acuity of 0.3 logarithm of the minimum angle of resolution (logMAR...
Brimonidine is used for hyperemia, the medical term for ocular redness. It is an ophthalmic solution developed by Bausch + Lomb Corporation (ticker BLCO) and has been studied in pediatric, adult, and geriatric participants. The clinical program includes three completed trials, all conducted in the United States.
Brimonidine targets the alpha-2 adrenergic receptors ADRA2A, ADRA2C, and ADRA2B, where it acts as an agonist. By binding these receptors, it belongs to the agonist target class. This receptor activity underlies its use as a small molecule ophthalmic agent for ocular redness.
Brimonidine is developed by Bausch + Lomb Corporation, which trades under the ticker BLCO. The company has sponsored the clinical development program for brimonidine tartrate ophthalmic solution, including the Phase 3 trials conducted in the United States.
Brimonidine is in Phase 3 clinical development for hyperemia. Three trials have been completed, including two Phase 3 studies and one Phase 1 pharmacokinetics and safety study. No trials are currently active. The program has enrolled a total of 579 participants across randomized, double-blind, placebo-controlled designs.
Brimonidine has been studied in three completed trials: NCT02039765, a Phase 1 pharmacokinetics and safety study in 12 healthy volunteers; NCT01959243, a Phase 3 safety study in 507 pediatric, adult, and geriatric participants; and NCT01959230, a Phase 3 efficacy and safety study in 60 adults and geriatric participants with ocular redness.
Yes, brimonidine tartrate is the same as brimonidine. Brimonidine tartrate is the salt form used in the ophthalmic solution studied in clinical trials, and the two names refer to the same active agent. Searches for either name refer to this small molecule developed by Bausch + Lomb.