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

NCT ID: NCT01845038

Last Updated: 2016-12-12

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

41 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-04-30

Study Completion Date

2014-05-31

Brief Summary

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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.

Detailed Description

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Conditions

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Glaucoma

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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OTX-TPa

OTX-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.

Group Type EXPERIMENTAL

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

Intervention Type DRUG

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.

OTX-TPb

OTX-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.

Group Type EXPERIMENTAL

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

Intervention Type DRUG

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.

Timolol

Timolol 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.

Group Type ACTIVE_COMPARATOR

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

Intervention Type DRUG

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

Interventions

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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.

Intervention Type 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.

Intervention Type 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.

Intervention Type DRUG

Eligibility Criteria

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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, and (T0 + 4h) and (T0 + 8h) IOP of ≥ 22 mm Hg at Baseline Visit 2. Untreated IOP must be ≤ 34 mm Hg in each eye at all time points at both baseline visits.
* Subject has a BCVA of 0.6 logMAR (20/80 Snellen) or better in each eye as measured using an ETDRS chart.

Exclusion Criteria

* Presence of any uncontrolled systemic or debilitating disease (e.g. cardiovascular disease, hypertension, diabetes, or cystic fibrosis).
* Punctum size is smaller than 0.4mm or greater than or equal to 1.0mm.
* Any single IOP in either eye at any time point during the Screening or either Baseline (Day -7/Day 0) Visits of \>34 mm Hg.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Ocular Therapeutix, Inc.

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Umhlanga Hospital Medical Centre

Durban, , South Africa

Site Status

Countries

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South Africa

Other Identifiers

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OTX-12-003

Identifier Type: -

Identifier Source: org_study_id