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Multi-Arm Feasibility Study Evaluating OTX-TP Compared to Timolol in Treatment of Subjects With Open Angle Glaucoma

NCT01845038 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 41

Last updated 2016-12-12

No results posted yet for this study

Summary

The purpose of this study is to evaluate how OTX-TP, a sustained release travoprost drug product, when placed in the canaliculus of the eyelid compares to timolol drops for the lowering of intraocular pressure (IOP) in patients with open angle glaucoma or ocular hypertension.

Conditions

Interventions

DRUG

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

OTX-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.

DRUG

OTX-TPb ~3µg/day over 3 months with natural tears drops

OTX-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.

DRUG

Timolol Maleate (0.5%) dosed twice daily with punctum plug without drug

Timolol Maleate (0.5%) ophthalmic solution dosed twice daily. Subjects in this arm will also have a hydrogel punctum plug without drug placed.

Sponsors & Collaborators

  • Ocular Therapeutix, Inc.

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2013-04-30
Primary Completion
2014-03-31
Completion
2014-05-31

Countries

  • South Africa

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01845038 on ClinicalTrials.gov