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NCT03519386 Clinical Trial

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
Secondary ID
Status Active, not recruiting
Phase Phase 3
First received
Last updated
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
Health authority
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.

Study Design

Related Conditions & MeSH terms

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
See also
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