Clinical Study Comparing Two Models of a Travoprost Intraocular Implant
Prospective, Randomized Phase III Study Comparing Two Models of a Travoprost Intraocular Implant to Timolol Maleate Ophthalmic Solution, 0.5%
1 other identifier
interventional
560
1 country
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)
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_3
Started Sep 2018
Longer than P75 for phase_3
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
September 17, 2018
CompletedFirst Submitted
Initial submission to the registry
March 6, 2019
CompletedFirst Posted
Study publicly available on registry
March 8, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 10, 2022
CompletedResults Posted
Study results publicly available
September 26, 2023
CompletedStudy Completion
Last participant's last visit for all outcomes
June 19, 2024
CompletedNovember 29, 2024
November 1, 2024
3.7 years
March 6, 2019
July 21, 2023
November 12, 2024
Conditions
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
EXPERIMENTALG2-TR intraocular implant containing Travoprost 75 mcg with high elution rate, plus postoperative placebo eye drops.
Implant Group 2
EXPERIMENTALG2-TR intraocular implant containing Travoprost 75 mcg with low elution rate, plus postoperative placebo eye drops.
Control Group
ACTIVE COMPARATORSham surgery + active-comparator eye drops
Interventions
Provided in Arm/Group descriptions
Sham surgery plus postoperative active-comparator eye drops (Timolol Maleate ophthalmic solution, 0.5%)
Eligibility Criteria
You may qualify if:
- Diagnosed with open-angle glaucoma or ocular hypertension
- C/D ratio ≤ 0.8
- Zero to two preoperative ocular hypotensive medications
You may not qualify if:
- Active corneal inflammation or edema
- Retinal disorders not associated with glaucoma
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Center for Sight
Las Vegas, Nevada, 89145, United States
Related Publications (3)
Singh IP, Reiss GR, Flowers BE, Katz LJ, Usner DW, Applegate D, Kothe AC, Navratil T. Administration of the Travoprost Intracameral Implant in an Office-Based Surgery Setting. Ophthalmol Ther. 2025 Dec;14(12):3109-3118. doi: 10.1007/s40123-025-01254-4. Epub 2025 Oct 4.
PMID: 41046316DERIVEDSingh 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: 39240530DERIVEDBacharach 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: 38985408DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
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
Study Officials
- STUDY CHAIR
Kerry Stephens, OD
Glaukos Corporation
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
March 6, 2019
First Posted
March 8, 2019
Study Start
September 17, 2018
Primary Completion
June 10, 2022
Study Completion
June 19, 2024
Last Updated
November 29, 2024
Results First Posted
September 26, 2023
Record last verified: 2024-11