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OpenTrials
Completed

NCT Number: NCT03519386

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

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).

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Key information

Conditions

Glaucoma, Open-Angle Eye Diseases Glaucoma Ocular Hypertension

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Vance Thompson Vision

Sioux Falls, South Dakota, 57108, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

G2-TR intraocular implant containing travoprost

Combination Product

Provided in Arm/Group descriptions.

Other names: Implant Group

Sham surgery + active-comparator eye drops

Drug

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

Other names: Control Group

Primary outcomes

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

    Time frame: 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 outcomes

  1. Mean IOP (Control Group vs. Each Implant Group) Through 12 Months Postoperative

    Time frame: 12 months

    Difference in mean IOP, between each test group and the control group, for IOP measurements through the Month 12 follow-up visit

Sponsors and collaborators

Lead sponsor

Glaukos Corporation

Industry

Registry information

Official study title

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

Important dates

Study start
2018
Primary completion
2022
Study completion
2024
First posted
May 9, 2018
Registry last updated
Nov 29, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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