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Phase 2/Phase 3 Trial to Evaluate the Safety and Efficacy of the Second Generation Travoprost Intracameral Implant

Phase 2/Phase 3 Trial to Evaluate the Safety and Efficacy of the Second Generation Travoprost Intracameral Implant

Status
Recruiting
Phases
Phase 2Phase 3
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT07075718
Enrollment
610
Registered
2025-07-20
Start date
2025-06-12
Completion date
2032-03-01
Last updated
2026-03-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Glaucoma

Keywords

open-angle glaucoma, ocular hypertension

Brief summary

Evaluate the Safety and Efficacy of the Second Generation Travoprost Intracameral Implant

Detailed description

Evaluate the Safety and Efficacy of the Second Generation Travoprost Intracameral Implant Compared to Timolol Ophthalmic Solution 0.5% Administered Twice Daily in Subjects with Open-Angle Glaucoma or Ocular Hypertension

Interventions

DRUGGen 2 Travoprost Intracameral Implant

travoprost

DRUGTimolol eye drops 0.5%

timolol 0.5%

PROCEDURESham Procedure

sham implant administration

OTHERPlacebo eye drops

artificial tears

Sponsors

Glaukos Corporation
Lead SponsorINDUSTRY

Study design

Allocation
RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

* Diagnosis of open-angle glaucoma or ocular hypertension in the study eye

Exclusion criteria

* 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

Design outcomes

Primary

MeasureTime frameDescription
Intraocular pressure (IOP)3 monthsChange from baseline in diurnal IOP in the study eye at 8AM and 10AM at each of Day 11, Week 6, and Month 3 visits

Countries

United States

Contacts

CONTACTStudy Director
ClinicalResearch@glaukos.com949-739-8749
STUDY_CHAIRLuis G. Vargas, MD

Glaukos Corporation

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 3, 2026