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

Primary Purpose

Glaucoma, Open-Angle, Ocular Hypertension

Status
Active
Phase
Phase 3
Locations
United States
Study Type
Interventional
Intervention
G2-TR intraocular implant containing travoprost
Sham surgery + active-comparator eye drops
Sponsored by
Glaukos Corporation
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Glaucoma, Open-Angle

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Vance Thompson Vision

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Active Comparator

Arm Label

Implant Group 1

Implant Group 2

Control Group

Arm Description

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

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

Sham surgery + active-comparator eye drops

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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

Full Information

First Posted
April 26, 2018
Last Updated
September 7, 2023
Sponsor
Glaukos Corporation
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1. Study Identification

Unique Protocol Identification Number
NCT03519386
Brief Title
Randomized Study Comparing Two Models of a Travoprost Intraocular Implant to Timolol Maleate Ophthalmic Solution, 0.5%
Official Title
Prospective, Randomized Phase III Study Comparing Two Models of a Travoprost Intraocular Implant to Timolol Maleate Ophthalmic Solution, 0.5%
Study Type
Interventional

2. Study Status

Record Verification Date
September 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
July 26, 2018 (Actual)
Primary Completion Date
April 5, 2022 (Actual)
Study Completion Date
June 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Glaukos Corporation

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Glaucoma, Open-Angle, Ocular Hypertension

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
590 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Implant Group 1
Arm Type
Experimental
Arm Description
G2-TR intraocular implant containing travoprost 75 mcg with high elution rate, plus postoperative placebo eye drops.
Arm Title
Implant Group 2
Arm Type
Experimental
Arm Description
G2-TR intraocular implant containing travoprost 75 mcg with low elution rate, plus postoperative placebo eye drops.
Arm Title
Control Group
Arm Type
Active Comparator
Arm Description
Sham surgery + active-comparator eye drops
Intervention Type
Combination Product
Intervention Name(s)
G2-TR intraocular implant containing travoprost
Other Intervention Name(s)
Implant Group
Intervention Description
Provided in Arm/Group descriptions.
Intervention Type
Drug
Intervention Name(s)
Sham surgery + active-comparator eye drops
Other Intervention Name(s)
Control Group
Intervention Description
Sham surgery plus postoperative active-comparator eye drops (timolol maleate ophthalmic solution, 0.5%).
Primary Outcome Measure Information:
Title
Change From Baseline in Diurnal IOP (as Measured at 8AM and 10AM) Through 3 Months Postoperative
Description
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.
Time Frame
3 months
Secondary Outcome Measure Information:
Title
Mean IOP (Control Group vs. Each Implant Group) Through 12 Months Postoperative
Description
Difference in mean IOP, between each test group and the control group, for IOP measurements through the Month 12 follow-up visit
Time Frame
12 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Kerry Stephens, O.D.
Organizational Affiliation
Glaukos Corporation
Official's Role
Study Chair
Facility Information:
Facility Name
Vance Thompson Vision
City
Sioux Falls
State/Province
South Dakota
ZIP/Postal Code
57108
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
35076329
Citation
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.
Results Reference
derived

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

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