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

NCT03519386 | Completed Phase 3 Results FDA Drug

• 1 other identifier: GC-010
• Study Type: interventional
• Target: 590
• Locations: 1 country
• Sites: 1

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).

Conditions

Glaucoma, Open-Angle; Ocular Hypertension

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

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

  12 months

Study Arms (3)

Implant Group 1

EXPERIMENTAL

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

Combination Product: G2-TR intraocular implant containing travoprost

Implant Group 2

EXPERIMENTAL

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

Combination Product: G2-TR intraocular implant containing travoprost

Control Group

ACTIVE COMPARATOR

Sham surgery + active-comparator eye drops

Drug: Sham surgery + active-comparator eye drops

Interventions

G2-TR intraocular implant containing travoprost COMBINATION_PRODUCT

Provided in Arm/Group descriptions.

Also known as: Implant Group

Implant Group 1; Implant Group 2

Sham surgery + active-comparator eye drops DRUG

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

Also known as: Control Group

Control Group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Glaukos Corporation: lead

Study Sites (1)

Vance Thompson Vision

Sioux Falls, South Dakota, 57108, United States

Location

Related Publications (4)

• 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.

  PMID: 39240530 DERIVED

• 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.

  PMID: 38985408 DERIVED

• 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.

  PMID: 38345710 DERIVED

• 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.

  PMID: 35076329 DERIVED

MeSH Terms

Conditions

Glaucoma, Open-Angle; Ocular Hypertension

Interventions

Control Groups

Condition Hierarchy (Ancestors)

Glaucoma; Eye Diseases

Intervention Hierarchy (Ancestors)

Epidemiologic Research Design; Epidemiologic Methods; Investigative Techniques; Research Design; Methods

Limitations and Caveats

This is an ongoing double-masked trial. Therefore, limited adverse event data are presented in order to prevent unmasking.

Results Point of Contact

• Title: Study Manager
• Organization: Glaukos

ldoan@glaukos.com

949-481-8076

Study Officials

• Kerry Stephens, O.D.

  Glaukos Corporation

  STUDY CHAIR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 26, 2018
• First Posted: May 9, 2018
• Study Start: July 26, 2018
• Primary Completion: April 5, 2022
• Study Completion: April 2, 2024
• Last Updated: November 29, 2024
• Results First Posted: September 14, 2023

Record last verified: 2024-11

Locations

US (1)