Study Comparing Travoprost Intraocular Implants to Timolol Ophthalmic Solution

Phase 2

Completed

• Conditions: Glaucoma Open-angle
• Interventions: Drug: Travoprost Intraocular Implant, low elution; Drug: Travoprost Intraocular Implant, high elution; Drug: Timolol Maleate Ophthalmic Solution, 0.5%

• Registration Number: NCT02754596
• Lead Sponsor: Glaukos Corporation

Brief Summary

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

Detailed 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.

Study Timeline

• Study First Submitted: 2016-03-15
• Study Start: 2016-03-29
• Study First Submitted QC: 2016-04-27
• Study First Posted: 2016-04-28
• Primary Completion: 2017-08-01
• Study Completion: 2020-07-21
• Results First Submitted: 2023-07-21
• Results First Submitted QC: 2023-07-21
• Results First Posted: 2023-08-09
• Status Verified: 2023-09
• Last Update Submitted: 2023-09-07
• Last Update Posted: 2023-09-26

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 154

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Travoprost Intraocular Implant, low elution	Travoprost Intraocular Implant, low elution	This implant will be surgically implanted and elute travoprost, a prostaglandin.
Travoprost Intraocular Implant, high elution	Travoprost Intraocular Implant, high elution	This implant will be surgically implanted and elute travoprost, a prostaglandin.
Timolol Maleate Ophthalmic Solution, 0.5%	Timolol Maleate Ophthalmic Solution, 0.5%	Timolol, a beta blocker, will be dosed twice daily

Primary Outcome Measures

Name	Time	Method
IOP (mmHg) Change From Baseline at Week 12	12 weeks	Change from baseline in IOP (measured in mmHg) at week 12. Negative values represent reductions in IOP from baseline.

Trial Locations

Locations (1)

John Berdahl, MD; 🇺🇸 Sioux Falls, South Dakota, United States