Study Comparing Travoprost Intraocular Implants to Timolol Ophthalmic Solution

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

154 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-03-29

Study Completion Date

2020-07-21

Brief Summary

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This is a randomized trial comparing two elution doses of the Travoprost Intraocular implant to timolol ophthalmic solution.

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Detailed Description

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This is a randomized trial comparing two elution doses of the Travoprost Intraocular implant to timolol ophthalmic solution in patients with open-angle glaucoma. Study assessments will include IOP and medication use as well as safety parameters.

Conditions

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Glaucoma Open-angle

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Outcome Assessors

Study Groups

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Travoprost Intraocular Implant, high elution

This implant will be surgically implanted and elute travoprost, a prostaglandin.

Group Type EXPERIMENTAL

Travoprost Intraocular Implant, high elution

Intervention Type DRUG

Surgical implant placed within the eye to elute travoprost.

Travoprost Intraocular Implant, low elution

This implant will be surgically implanted and elute travoprost, a prostaglandin.

Group Type EXPERIMENTAL

Travoprost Intraocular Implant, low elution

Intervention Type DRUG

Surgical implant placed within the eye to elute travoprost

Timolol Maleate Ophthalmic Solution, 0.5%

Timolol, a beta blocker, will be dosed twice daily

Group Type ACTIVE_COMPARATOR

Timolol Maleate Ophthalmic Solution, 0.5%

Intervention Type DRUG

Instillation of one drop of timolol in the study eye twice daily

Interventions

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Travoprost Intraocular Implant, high elution

Surgical implant placed within the eye to elute travoprost.

Intervention Type DRUG

Travoprost Intraocular Implant, low elution

Surgical implant placed within the eye to elute travoprost

Intervention Type DRUG

Timolol Maleate Ophthalmic Solution, 0.5%

Instillation of one drop of timolol in the study eye twice daily

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Open angle glaucoma

Exclusion Criteria

* Uveitic, neovascular, or angle closure glaucoma; or glaucoma associated with vascular disorders.
* Functionally significant visual field loss, including severe nerve fiber bundle defects.
* Prior glaucoma surgery.
* Uncontrolled systemic disease, pregnant females or those planning a pregnancy.
* Other ocular status conditions, etc.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No