Study Comparing Travoprost Intraocular Implants to Timolol Ophthalmic Solution

Glaukos

Status and phase: Completed; Phase 2

Conditions: Glaucoma Open-angle

Treatments: Drug: Travoprost Intraocular Implant, low elution; Drug: Travoprost Intraocular Implant, high elution; Drug: Timolol Maleate Ophthalmic Solution, 0.5%

Study type: Interventional

Funder types: Industry

Identifiers

NCT02754596

GC-009

Details and patient eligibility

About

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

Full description

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.

Enrollment: 154 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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154 participants in 3 patient groups

Travoprost Intraocular Implant, high elution

Experimental group

Description:

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

Treatment:

Drug: Travoprost Intraocular Implant, high elution

Travoprost Intraocular Implant, low elution

Experimental group

Description:

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

Treatment:

Drug: Travoprost Intraocular Implant, low elution

Timolol Maleate Ophthalmic Solution, 0.5%

Active Comparator group

Description:

Timolol, a beta blocker, will be dosed twice daily

Treatment:

Drug: Timolol Maleate Ophthalmic Solution, 0.5%