Study Comparing Travoprost Intraocular Implants to Timolol Ophthalmic Solution

Glaucoma Open-angle Clinical Trial

Official title:

Prospective, Randomized Phase II Study Comparing Two Elution Rates of Glaukos Travoprost Intraocular Implants to Timolol Maleate Ophthalmic Solution, USP 0.5%

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02754596
• Other study ID #: GC-009
• Status: Completed
• Phase: Phase 2
• Start date: March 29, 2016
• Est. completion date: July 21, 2020

Study information

• Verified date: September 2023
• Source: Glaukos Corporation
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 154
• Est. completion date: July 21, 2020
• Est. primary completion date: August 1, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Glaucoma Open-angle
• Glaucoma, Open-Angle

Intervention

Drug:
• Travoprost Intraocular Implant, high elution
Surgical implant placed within the eye to elute travoprost.
• Travoprost Intraocular Implant, low elution
Surgical implant placed within the eye to elute travoprost
• Timolol Maleate Ophthalmic Solution, 0.5%
Instillation of one drop of timolol in the study eye twice daily

Locations

Country	Name	City	State
United States	John Berdahl, MD	Sioux Falls	South Dakota

Sponsors (1)

Lead Sponsor	Collaborator
Glaukos Corporation

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Severe Adverse Events	The number and percent of subjects with severe adverse events in the study eye	Post-op through Month 36
Primary	IOP (mmHg) Change From Baseline at Week 12	Change from baseline in IOP (measured in mmHg) at week 12. Negative values represent reductions in IOP from baseline.	12 weeks