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bepotastine besilate

Phase 3

Allergic Conjunctivitis | Small molecule | Other |Bausch + Lomb Corporation|Last Updated: Sep 14, 2020

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_CONTROLLED
Total Trials2
Total Enrollment375
FDA Designations
No designations recorded
Clinical Trials (2)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT00586664Efficacy and Safety Study of Bepotastine Besilate Ophthalmic Solution in Allergic ConjunctivitisPHASE3 COMPLETED 130Oct 1, 2007Jun 1, 2008Feb 8, 20131 United States
NCT01174823Safety and Efficacy of Bepotastine Besilate Ophthalmic Solution in Seasonal Allergic Conjunctivitis PatientsPHASE2 COMPLETED 245Jun 1, 2010Dec 1, 2010Sep 14, 20201 United States
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Study Endpoints
Primary Endpoints
Ocular Itching
15 minutes, 8 hours & 16 hours post-dose from Conjunctival Allergen Challenge (CAC) Model

Ocular Itching score: 0=None; 0.5=Intermittent tickle sensation possibly localized in the corner of the eye; 1.0=Intermittent tickle sensation involving more than the corner of the eye; 1.5=Intermittent all-over tickling sensation; 2.0=Mild continuous itch (can be localized) without desire to rub; 2.5=Moderate, diffuse continuous itch with desire to rub; 3.0=Severe itch with desire to rub; 3.5=Severe itch improved with minimal rubbing; 4.0=Incapacitating itch with irresistible urge to rub

Conjunctival Redness
15 minutes, 8 hours & 16 hours post-dose from Conjunctival Allergen Challenge (CAC) Model

Conjunctival Redness score: 0=None; 1.0=Mild-Slightly dilated blood vessels; color of vessels typically pink; 2.0=Moderate-More apparent dilation of blood vessels; vessel color more intense (redder); 3.0=Severe-Numerous, obvious dilated blood vessels; absence of chemosis color is deep red, presence of chemosis may be less red or pink; 4.0=Extremely severe-Large, numerous dilated blood vessels characterized by severe deep red color regardless of chemosis grade

Rhinoconjunctivitis Quality of Life Questionnaire (RQLQ) - Mean Change in Total Score
Baseline, 14 days

Responses to questions relating to symptoms and daily activities in the RQLQ were provided for 28 questions encompassing the 7 major domains of activities, sleep, non-nose/eye symptoms, practical problems, nasal symptoms, eye symptoms, and emotional state. Each response to an RQLQ question was provided on a scale of 0-6 units, where 0 = not troubled/none of the time and 6 = extremely troubled/all of the time. The minimum total score was 0 units and the maximum total score was 42 units, with higher score indicating decreased quality of life due to rhinoconjunctivitis.

Secondary Endpoints
Ciliary Redness
15 Minutes, 8 Hours & 16 Hours post-dose from Conjunctival Allergen Challenge (CAC) Model
Episcleral Redness
15 Minutes, 8 Hours & 16 Hours post-dose from Conjunctival Allergen Challenge (CAC) Model
Chemosis
15 Minutes, 8 Hours & 16 Hours post-dose from Conjunctival Allergen Challenge (CAC) Model
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Study Design & Arms
AllocationRANDOMIZED
MaskingTRIPLE
ModelPARALLEL
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
Bepreve (Bepotastine Besilate Ophthalmic Solution) 1.5%EXPERIMENTAL -
Bepotastine Besilate Ophthalmic Solution 1.0%EXPERIMENTAL -
PlaceboPLACEBO_COMPARATOR -
Bepotastine Besilate Ophthalmic SolutionEXPERIMENTAL -
Interventions
NameTypeDescription
Bepreve (bepotastine besilate ophthalmic solution) 1.5%DRUGsterile ophthalmic solution
placebo comparatorDRUGsterile ophthalmic solution
Bepotastine Besilate Ophthalmic Solution 1.0%DRUGsterile ophthalmic solution
bepotastine besilate ophthalmic solutionDRUGsterile ophthalmic solution
placebo comparator ophthalmic solutionDRUGsterile ophthalmic solution
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Eligibility Criteria
Age Range10 Years — N/A
SexALL
Healthy VolunteersNo
Study Sites1

Inclusion Criteria: * Subjects must be at least 10 years of age Exclusion Criteria: * No active ocular disease

Countries:United States
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