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OTX-TPa ~4µg/day over 2 mos. with natural tears

Phase 1

Glaucoma | Small molecule | Ophthalmology |Ocular Therapeutix, Inc.|Last Updated: Dec 12, 2016

Success Probability

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Market & Valuation

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Trial Design

RandomizedDouble-BlindACTIVE_CONTROLLED
Total Trials1
Total Enrollment41

FDA Designations

No designations recorded

Clinical trial landscape

OTX-TPa ~4µg/day over 2 mos. with natural tears · 1 trial · 1 indication

Phase 1 1
NCT01845038Multi-Arm Feasibility Study Evaluating OTX-TP Compared to Timolol in Treatment of Subjects With Open Angle GlaucomaGlaucoma
COMPLETED41 Analytics
PHASE1COMPLETED
Multi-Arm Feasibility Study Evaluating OTX-TP Compared to Timolol in Treatment of Subjects With Open Angle Glaucoma
GlaucomaUnlock trial analytics

Study Endpoints

Primary Endpoints

Mean IOP change from baseline
90 days

Secondary Endpoints

Visualization of OTX-TP punctum plug by subject
90 days
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Study Design & Arms

AllocationRANDOMIZED
MaskingQUADRUPLE
ModelPARALLEL
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
OTX-TPaEXPERIMENTALOTX-TPa is a hydrogel punctum plug eluting travoprost in sustained release of \~4µg/day over approximately 2 months. For study masking purposes, subjects in this arm will also have natural tears drops administered.
OTX-TPbEXPERIMENTALOTX-TPb is a hydrogel punctum plug eluting travoprost in sustained release of \~3µg/day over approximately 3 months. For study masking purposes, subjects in this arm will also have natural tears drops administered.
TimololACTIVE_COMPARATORTimolol Maleate (0.5%) ophthalmic solution dosed twice daily (BID). For study masking purposes, subjects in this arm will also have a hydrogel punctum plug with no drug placed for approximately 3 months.

Interventions

NameTypeDescription
OTX-TPa ~4µg/day over 2 mos. with natural tears dropsDRUGOTX-TPa is a hydrogel punctum plug eluting travoprost in a sustained release of \~4µg/day over 2 months. Subjects in this arm will also receive natural tears drops.
OTX-TPb ~3µg/day over 3 months with natural tears dropsDRUGOTX-TPb is a hydrogel punctum plug eluting travoprost in a sustained release of \~3µg/day over 3 months. Subjects in this arm will also receive natural tears drops.
Timolol Maleate (0.5%) dosed twice daily with punctum plug without drugDRUGTimolol Maleate (0.5%) ophthalmic solution dosed twice daily. Subjects in this arm will also have a hydrogel punctum plug without drug placed.
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Eligibility Criteria

Age Range18 Years to N/A
SexALL
Healthy VolunteersNo
Study Sites1

Inclusion Criteria: * Subject must be greater than or equal to 18 years of age at Screening. * Subject must have a documented diagnosis of ocular hypertension, open angle glaucoma. * Subject has a mean baseline (Day -7 and Day 0) Hour 0 (T0) untreated IOP of ≥ 24 mm Hg and ≤ 34 mm Hg in each eye, a...

Countries:South Africa
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