Study Comparing Travoprost Intraocular Implants to Timolol Ophthalmic Solution

• Sponsor: Glaukos Corporation (Industry)
• Overall Status: Active, not recruiting
• CT.gov ID: NCT02754596
• Collaborator: (none)
• Enrollment: 300
• Location: 1
• Arms: 3
• Duration (Months): 69
• Patients Per Site Per Month: 4.3

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Glaucoma Open-angle	Drug: Travoprost Intraocular Implant, high elution; Drug: Travoprost Intraocular Implant, low elution; Drug: Timolol Maleate Ophthalmic Solution, 0.5%	Phase 2

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 Design

• Study Type: Interventional
• Anticipated Enrollment: 300 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Double (Participant, Outcomes Assessor)
• Primary Purpose: Treatment
• Official Title: Prospective, Randomized Phase II Study Comparing Two Elution Rates of Glaukos Travoprost Intraocular Implants to Timolol Maleate Ophthalmic Solution, USP, 0.5%
• Study Start Date: Mar 1, 2016
• Actual Primary Completion Date: Sep 1, 2017
• Anticipated Study Completion Date: Dec 1, 2021

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Travoprost Intraocular Implant, high elution This implant will be surgically implanted and elute travoprost, a prostaglandin.	Drug: Travoprost Intraocular Implant, high elution; Surgical implant placed within the eye to elute travoprost.
Experimental: Travoprost Intraocular Implant, low elution This implant will be surgically implanted and elute travoprost, a prostaglandin.	Drug: Travoprost Intraocular Implant, low elution; Surgical implant placed within the eye to elute travoprost
Active Comparator: Timolol Maleate Ophthalmic Solution, 0.5% Timolol, a beta blocker, will be dosed twice daily	Drug: Timolol Maleate Ophthalmic Solution, 0.5%; Instillation of one drop of timolol in the study eye twice daily

Outcome Measures

Primary Outcome Measures

1. Intraocular pressure (IOP) measured in mm Hg [12 weeks]

   IOP reduction--mean diurnal values from 8am, 10 am, and 4 pm

Other Outcome Measures

1. Adverse events [Post-op through 12 weeks]

   The number and percent of adverse events will be reported

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	John Berdahl, MD	Sioux Falls	South Dakota	United States	57108

Sponsors and Collaborators

• Glaukos Corporation

Investigators

• Study Chair: Kerry Stephens, O.D., Glaukos Corporation

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Glaukos Corporation
• ClinicalTrials.gov Identifier: NCT02754596
• Other Study ID Numbers: GC-009
• First Posted: Apr 28, 2016
• Last Update Posted: Apr 30, 2021
• Last Verified: Apr 1, 2021

• Individual Participant Data (IPD) Sharing Statement: Undecided
• Plan to Share IPD: Undecided
• Additional relevant MeSH terms: Glaucoma, Open-Angle; Timolol; Travoprost; Ophthalmic Solutions

Study Results

No Results Posted as of Apr 30, 2021