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

NCT ID: NCT03519386

Last Updated: 2024-11-29

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

590 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-07-26

Study Completion Date

2024-04-02

Brief Summary

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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

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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

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Glaucoma, Open-Angle Ocular Hypertension

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Outcome Assessors

Study Groups

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Implant Group 1

G2-TR intraocular implant containing travoprost 75 mcg with high elution rate, plus postoperative placebo eye drops.

Group Type EXPERIMENTAL

G2-TR intraocular implant containing travoprost

Intervention Type COMBINATION_PRODUCT

Provided in Arm/Group descriptions.

Implant Group 2

G2-TR intraocular implant containing travoprost 75 mcg with low elution rate, plus postoperative placebo eye drops.

Group Type EXPERIMENTAL

G2-TR intraocular implant containing travoprost

Intervention Type COMBINATION_PRODUCT

Provided in Arm/Group descriptions.

Control Group

Sham surgery + active-comparator eye drops

Group Type ACTIVE_COMPARATOR

Sham surgery + active-comparator eye drops

Intervention Type DRUG

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

Interventions

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G2-TR intraocular implant containing travoprost

Provided in Arm/Group descriptions.

Intervention Type COMBINATION_PRODUCT

Sham surgery + active-comparator eye drops

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

Intervention Type DRUG

Other Intervention Names

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Implant Group Control Group

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Glaukos Corporation

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Kerry Stephens, O.D.

Role: STUDY_CHAIR

Glaukos Corporation

Locations

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Vance Thompson Vision

Sioux Falls, South Dakota, United States

Site Status

Countries

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United States

References

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Singh IP, Berdahl JP, Sarkisian SR Jr, Voskanyan LA, Ang RE, Doan LV, Applegate D, Shen Y, Katz LJ, Kothe AC, Navratil T. Long-Term Safety and Efficacy Evaluation of Travoprost Intracameral Implant Based on Pooled Analyses from Two Phase III Trials. Drugs. 2024 Oct;84(10):1299-1311. doi: 10.1007/s40265-024-02074-9. Epub 2024 Sep 6.

Reference Type DERIVED
PMID: 39240530 (View on PubMed)

Bacharach J, Doan LV, Stephens KG, Usner DW, Kothe AC, Katz LJ, Navratil T. Travoprost Intracameral Implant Demonstrates Superior IOP Lowering Versus Topical Prostaglandin Analog Monotherapy in Patients with Open-Angle Glaucoma or Ocular Hypertension. Ophthalmol Ther. 2024 Sep;13(9):2357-2367. doi: 10.1007/s40123-024-00992-1. Epub 2024 Jul 10.

Reference Type DERIVED
PMID: 38985408 (View on PubMed)

Sarkisian SR, Ang RE, Lee AM, Berdahl JP, Heersink SB, Burden JH, Doan LV, Stephens KG, Applegate D, Kothe AC, Usner DW, Katz LJ, Navratil T. Travoprost Intracameral Implant for Open-Angle Glaucoma or Ocular Hypertension: 12-Month Results of a Randomized, Double-Masked Trial. Ophthalmol Ther. 2024 Apr;13(4):995-1014. doi: 10.1007/s40123-024-00898-y. Epub 2024 Feb 12.

Reference Type DERIVED
PMID: 38345710 (View on PubMed)

Belamkar A, Harris A, Zukerman R, Siesky B, Oddone F, Verticchio Vercellin A, Ciulla TA. Sustained release glaucoma therapies: Novel modalities for overcoming key treatment barriers associated with topical medications. Ann Med. 2022 Dec;54(1):343-358. doi: 10.1080/07853890.2021.1955146.

Reference Type DERIVED
PMID: 35076329 (View on PubMed)

Provided Documents

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Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Other Identifiers

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GC-010

Identifier Type: -

Identifier Source: org_study_id