Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
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 an investigational small molecule being developed by Bausch + Lomb Corporation for the treatment of hyperemia, or ocular redness. It is formulated as a brimonidine tartrate ophthalmic solution and is currently in Phase 3 clinical development for this indication.
Brimonidine is being developed by Bausch + Lomb Corporation, which trades under the ticker BLCO. The company is conducting clinical trials to evaluate the safety and efficacy of brimonidine tartrate ophthalmic solution for the treatment of hyperemia.
Brimonidine is in Phase 3 clinical development for hyperemia. It is an investigational drug and has not been approved by the FDA. Three clinical trials have been completed, including two Phase 3 studies and one Phase 1 study.
Brimonidine has been studied in three completed clinical trials. NCT01959230 evaluated efficacy and safety in adults with ocular redness, NCT01959243 assessed safety across pediatric and adult populations, and NCT02039765 examined pharmacokinetics and safety of a 0.025% solution.
Brimonidine is the active ingredient in brimonidine tartrate ophthalmic solution. The clinical trials for this drug use the tartrate salt form, and the drug is referred to as brimonidine tartrate in the study titles.