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BOL-303224-A

Phase 1

Conjunctivitis, Bacterial | Small molecule | Infectious Disease |Bausch + Lomb Corporation|Last Updated: Dec 9, 2011

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
UNCONTROLLEDBiomarker
Total Trials1
Total Enrollment24
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT00407589Systemic Pharmacokinetics of BOL-303224-APHASE1 COMPLETED 24 — — Oct 1, 2006Oct 1, 2007Dec 9, 20111 United States
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Study Endpoints
Primary Endpoints
Assessment of systemic pharmacokinetics following a single dose and steady-state pharmacokinetics after multiple TID dosing
Blood samples will be collected from 0 to 6 hours on Day 1 and from 0 to 12 hours on Day 6. There will be additional sampling times at 0 hours on Day 2-5.
Secondary Endpoints
Investigator ratings of ocular discharge and bulbar conjunctival injection, Visual Acuity, ophthalmoscopy findings and Adverse event collection
Througout the study
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Study Design & Arms
AllocationNA
MaskingNONE
ModelSINGLE_GROUP
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
BOL-303224-AEXPERIMENTALSystemic exposure of BOL-303224-A following single and multiple topical doses
Interventions
NameTypeDescription
BOL-303224-ADRUG1 drop in each eye, TID for 5 days at approximately 6 h intervals, with a final, single dose on the morning of Visit 7 (Day 6).
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Eligibility Criteria
Age Range18 Years — N/A
SexALL
Healthy VolunteersNo
Study Sites1

Inclusion Criteria: * must be at least 18 years of age, any race * must have a clinical diagnosis of acute bacterial conjunctivitis and exhibit purulent conjunctival discharge and redness in both eyes * women of childbearing potential must utilize reliable contraceptive methods and have a negative ...

Countries:United States
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