Randomized Study Comparing Two Models of a Travoprost Intraocular Implant to Timolol Maleate Ophthalmic Solution, 0.5%

Ocular Hypertension Clinical Trial

Official title:

Prospective, Randomized Phase III Study Comparing Two Models of a Travoprost Intraocular Implant to Timolol Maleate Ophthalmic Solution, 0.5%

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT03519386
• Other study ID #: GC-010
• Status: Active, not recruiting
• Phase: Phase 3
• Start date: July 26, 2018
• Est. completion date: June 2024

Study information

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

Clinical Trial Summary

Phase III study to compare the safety and efficacy of intraocular implants containing travoprost at two different elution rates versus Timolol Maleate Ophthalmic Solution, 0.5% (timolol) in reducing elevated intraocular pressure in subjects with open-angle glaucoma (OAG) or ocular hypertension (OHT).

Description:

This is a prospective, randomized, double-masked, active-controlled, parallel-group, multi-center trial comparing the efficacy and safety of the Model G2TR 063 Travoprost Intraocular Implant and the Model G2TR-125 Travoprost Intraocular Implant to topical timolol in subjects with OAG or OHT. The staff who record key efficacy measures and the study subjects will remain masked to study treatment.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 590
• Est. completion date: June 2024
• Est. primary completion date: April 5, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Diagnosed with open-angle glaucoma or ocular hypertension.
• C/D ratio = 0.8
• Zero to three preoperative ocular hypotensive medications

Exclusion Criteria:

• Active corneal inflammation or edema.
• Retinal disorders not associated with glaucoma.

Related Conditions & MeSH terms

• Glaucoma, Open-Angle
• Ocular Hypertension

Intervention

Combination Product:
• G2-TR intraocular implant containing travoprost
Provided in Arm/Group descriptions.

Drug:
• Sham surgery + active-comparator eye drops
Sham surgery plus postoperative active-comparator eye drops (timolol maleate ophthalmic solution, 0.5%).

Locations

Country	Name	City	State
United States	Vance Thompson Vision	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
Primary	Change From Baseline in Diurnal IOP (as Measured at 8AM and 10AM) Through 3 Months Postoperative	Change from time-matched baseline in IOP at 8AM and 10AM at Day 10, Week 6 and Month 3.; Day 10 8AM IOP minus Baseline 8AM IOP; Day 10 10AM IOP minus Baseline 10AM IOP; Week 6 8AM IOP minus Baseline 8AM IOP; Week 6 10AM IOP minus Baseline 10AM IOP; Month 3 8AM IOP minus Baseline 8AM IOP; Month 3 10AM IOP minus Baseline 10AM IOP.	3 months
Secondary	Mean IOP (Control Group vs. Each Implant Group) Through 12 Months Postoperative	Difference in mean IOP, between each test group and the control group, for IOP measurements through the Month 12 follow-up visit	12 months