NCT03519386

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

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

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 590 (actual)
• Sponsor: Glaukos Corporation · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Glaucoma, Open-Angle
• Ocular Hypertension

Interventions

Type	Name	Description
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%).

Timeline

• Start date: 2018-07-26
• Primary completion: 2022-04-05
• Completion: 2024-04-02
• First posted: 2018-05-09
• Last updated: 2024-11-29
• Results posted: 2023-09-14

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study