Phase 2/Phase 3 Trial to Evaluate the Safety and Efficacy of the Second Generation Travoprost Intracameral Implant
1 other identifier
interventional
610
1 country
3
Brief Summary
Evaluate the Safety and Efficacy of the Second Generation Travoprost Intracameral Implant
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2
Started Jun 2025
Longer than P75 for phase_2
3 active sites
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
June 12, 2025
CompletedFirst Submitted
Initial submission to the registry
July 10, 2025
CompletedFirst Posted
Study publicly available on registry
July 20, 2025
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 1, 2028
ExpectedStudy Completion
Last participant's last visit for all outcomes
March 1, 2032
March 2, 2026
February 1, 2026
2.7 years
July 10, 2025
February 26, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Intraocular pressure (IOP)
Change from baseline in diurnal IOP in the study eye at 8AM and 10AM at each of Day 11, Week 6, and Month 3 visits
3 months
Study Arms (9)
Period 1 (Cohort A)
EXPERIMENTALSingle-arm, open-label portion of Phase 2; subjects will receive second generation travoprost intracameral implant (plus placebo eyedrops BID) in the study eye and be followed for 36 months
Period 2 (Cohort B) Gen 2 Travoprost Intracameral Implant Arm
EXPERIMENTALRandomized, double-masked, active-controlled Phase 2 portion of the trial; subjects will receive second generation travoprost intracameral implant (plus placebo eyedrops BID) in the study eye and be followed for 36 months
Period 2 (Cohort B) Timolol Arm
ACTIVE COMPARATORRandomized, double-masked, active-controlled, Phase 2 portion of the trial; subjects will administer timolol 0.5% eye drops BID (plus sham procedure) in the study eye and be followed for 36 months
Period 3 (Cohort X) Gen 2 Travoprost Intracameral Implant Arm
EXPERIMENTALRandomized, double-masked, active-controlled, Phase 3 portion of the trial; subjects will receive second generation travoprost intracameral implant (plus placebo eyedrops BID) in the study eye and undergo an exchange procedure at month 12 and be followed for an additional 12 months
Period 3 (Cohort X) Timolol Arm
ACTIVE COMPARATORRandomized, double-masked, active-controlled, Phase 3 portion of the trial; subjects will administer timolol 0.5% eye drops BID (plus sham procedure) in the study eye and undergo a sham exchange procedure at month 12 and be followed for an additional 12 months
Period 3 (Cohort Y) Gen 2 Travoprost Intracameral Implant Arm
ACTIVE COMPARATORRandomized, double-masked, active-controlled, Phase 3 portion of the trial, subjects will receive second generation travoprost intracameral implant (plus placebo eyedrops BID) in the study eye and undergo an exchange procedure at month 24 and be followed for an additional 12 months
Period 3 (Cohort Y) Timolol Arm
ACTIVE COMPARATORRandomized, double-masked, active-controlled, Phase 3 portion of the trial; subjects will receive timolol 0.5% eye drops BID (plus sham procedure) in the study eye and undergo a sham exchange procedure at month 24 and be followed for an additional 12 months
Period 3 (Cohort Z) Gen 2 Travoprost Intracameral Implant Arm
EXPERIMENTALRandomized, double-masked, active-controlled, Phase 3 portion of the trial, subjects will receive second generation travoprost intracameral implant (plus placebo eyedrops BID) in the study eye and undergo an exchange procedure at month 36 and be followed for an additional 12 months
Period 3 (Cohort Z) Timolol Arm
ACTIVE COMPARATORRandomized, double-masked, active-controlled, Phase 3 portion of the trial; subjects will administer timolol 0.5% eye drops BID (plus sham procedure) in the study eye and undergo an sham exchange procedure at month 36 and be followed for an additional 12 months
Interventions
travoprost
timolol 0.5%
sham implant administration
artificial tears
Eligibility Criteria
You may qualify if:
- Diagnosis of open-angle glaucoma or ocular hypertension in the study eye
You may not qualify if:
- Prior incisional glaucoma surgery in the study eye
- Prior argon laser trabeculoplasty (ALT) in the study eye
- Prior minimally invasive glaucoma (MIGS) surgery in the study eye
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (3)
Glaukos Investigative Site
Grand Junction, Colorado, 81501, United States
Glaukos Investigative Site
Oklahoma City, Oklahoma, 73112, United States
Glaukos Clinical Site
El Paso, Texas, 79922, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY CHAIR
Luis G. Vargas, MD
Glaukos Corporation
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- SEQUENTIAL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
July 10, 2025
First Posted
July 20, 2025
Study Start
June 12, 2025
Primary Completion (Estimated)
March 1, 2028
Study Completion (Estimated)
March 1, 2032
Last Updated
March 2, 2026
Record last verified: 2026-02
Data Sharing
- IPD Sharing
- Will not share