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

Phase 3

Completed

• Conditions: Glaucoma, Open-Angle; Ocular Hypertension
• Interventions: Combination Product: G2-TR intraocular implant containing travoprost; Drug: Sham surgery + active-comparator eye drops

• Registration Number: NCT03519386
• Lead Sponsor: Glaukos Corporation

Brief 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).

Detailed 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.

Study Timeline

• Study First Submitted: 2018-04-26
• Study First Submitted QC: 2018-04-26
• Study First Posted: 2018-05-09
• Study Start: 2018-07-26
• Primary Completion: 2022-04-05
• Results First Submitted: 2023-07-21
• Results First Submitted QC: 2023-09-07
• Results First Posted: 2023-09-14
• Study Completion: 2024-04-02
• Status Verified: 2024-11
• Last Update Submitted: 2024-11-12
• Last Update Posted: 2024-11-29

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 590

Inclusion Criteria

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

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Exclusion Criteria

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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Implant Group 1	G2-TR intraocular implant containing travoprost	G2-TR intraocular implant containing travoprost 75 mcg with high elution rate, plus postoperative placebo eye drops.
Implant Group 2	G2-TR intraocular implant containing travoprost	G2-TR intraocular implant containing travoprost 75 mcg with low elution rate, plus postoperative placebo eye drops.
Control Group	Sham surgery + active-comparator eye drops	Sham surgery + active-comparator eye drops

Primary Outcome Measures

Name	Time	Method
Change From Baseline in Diurnal IOP (as Measured at 8AM and 10AM) Through 3 Months Postoperative	3 months	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.

Secondary Outcome Measures

Name	Time	Method
Mean IOP (Control Group vs. Each Implant Group) Through 12 Months Postoperative	12 months	Difference in mean IOP, between each test group and the control group, for IOP measurements through the Month 12 follow-up visit

Trial Locations

Locations (1)

Vance Thompson Vision; 🇺🇸 Sioux Falls, South Dakota, United States