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Brimonidine

Phase 3

Hyperemia | Small molecule | Other |Bausch + Lomb Corporation|Last Updated: Oct 23, 2019

Success Probability
Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
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Market & Valuation
rNPV $3.2B
Market Size $9.4B
Revenue Basis $1.6B
Competitors 6
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Trial Design
RandomizedDouble-BlindPLACEBO_CONTROLLEDBiomarker
Total Trials3
Total Enrollment579
FDA Designations
No designations recorded
Clinical Trials (3)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT01959243Safety of Brimonidine Tartrate Ophthalmic Solution in a Population of Pediatric, Adult, and Geriatric ParticipantsPHASE3 COMPLETED 507Feb 22, 2014Jun 23, 2014Oct 23, 20194 United States
NCT01959230Efficacy and Safety of Brimonidine Tartrate Ophthalmic Solution in Adult and Geriatric Participants With Ocular RednessPHASE3 COMPLETED 60Nov 7, 2013Dec 20, 2013Oct 23, 20191 United States
NCT02039765Pharmacokinetics and Safety of Topical Administration of Brimonidine Tartrate Ophthalmic Solution 0.025%.PHASE1 COMPLETED 12Feb 1, 2014Apr 1, 2014Apr 28, 20171 United States
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Study Endpoints
Primary Endpoints
Number of Participants With Treatment Emergent Adverse Events (TEAEs)
Baseline up to Day 29

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 as Measured by the Investigator Using the Ora Calibra™ Ocular Hyperemia Scale
0 (predose), 5, 15, 30, 60, 90, 120, 180, and 240 minutes postdose on Day 1

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.

Plasma Levels
Day 1 (Visit 2)

Blood samples will be collected for the determination of brimonidine in plasma at the specified time points on Day 1.

Secondary Endpoints
Drop Comfort Assessment as Assessed by the Participant
At dose installation, 30 seconds postdose installation, and 1 minute postdose installation on Day 1
Number of Participants Who Were Fully Alert as Assessed by the Investigator on Days 1, 8, 15, and 29
Predose installation on Day 1 and 90-180 minutes postdose installation on Days 1, 8, 15, and 29
Ocular Redness as Measured by the Participant
Day 1 to Day 15; Day 15 to Day 29; Day 29 to Day 36
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Study Design & Arms
AllocationRANDOMIZED
MaskingDOUBLE
ModelPARALLEL
PurposeOTHER
Treatment Arms
ArmTypeDescription
Brimonidine TartrateEXPERIMENTALParticipants 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 VehiclePLACEBO_COMPARATORParticipants will apply 1 drop of the vehicle of brimonidine tartrate ophthalmic solution into each eye 4 times daily for up to 4 consecutive weeks.
Interventions
NameTypeDescription
Brimonidine TartrateDRUGOphthalmic solution to be applied as directed.
VehicleDRUGOphthalmic solution to be applied as directed.
Sodium FluoresceinDRUGFor use as needed during the study for evaluating corneal damage.
Fluorescein Sodium and Benoximate Hydrocholoride Ophthalmic Solution USPDRUGFor use as needed during the study for intraocular pressure and dilated ophthalmoscopy.
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Eligibility Criteria
Age Range5 Years — N/A
SexALL
Healthy VolunteersYes
Study Sites4

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...

Countries:United States
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