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

Recruitment Status
RECRUITING
(See Contacts and Locations)Verified January 2026 by Glaukos Corporation
Sponsor
Glaukos Corporation
Information Provided by (Responsible Party)
Glaukos Corporation
Clinicaltrials.gov Identifier
NCT07075718
Other Study ID Numbers:
GLK-102-01
First Submitted
July 9, 2025
First Posted
July 19, 2025
Last Update Posted
March 1, 2026
Last Verified
January 2026

ClinicalTrials.gov processed this data on February 2026. Link to the current ClinicalTrials.gov record .

History of Changes

Study Details

Study 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

Condition or DiseaseIntervention/Treatment
Glaucoma
Drug: Gen 2 Travoprost Intracameral ImplantDrug: Gen 2 Travoprost Intracameral ImplantDrug: Timolol eye drops 0.5%Drug: Gen 2 Travoprost Intracameral ImplantDrug: Timolol eye drops 0.5%Drug: Gen 2 Travoprost Intracameral ImplantDrug: Timolol eye drops 0.5%Drug: Gen 2 Travoprost Intracameral ImplantDrug: Timolol eye drops 0.5%

Study Design

Study TypeInterventional
Actual Enrollment610 participants
Design AllocationRandomized
Interventional ModelSequential Assignment
MaskingTriple
Primary PurposeTreatment
Official TitlePhase 2/Phase 3 Trial to Evaluate the Safety and Efficacy of the Second Generation Travoprost Intracameral Implant
Study Start DateJune 11, 2025
Actual Primary Completion Date1yr 9mos from now
Actual Study Completion Date5yrs 9mos from now

Groups and Cohorts

Group/CohortIntervention/Treatment
Period 1 (Cohort A)
Single-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
Drug: Gen 2 Travoprost Intracameral Implant
travoprost
Period 2 (Cohort B) Gen 2 Travoprost Intracameral Implant Arm
Randomized, 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
Drug: Gen 2 Travoprost Intracameral Implant
travoprost
Period 2 (Cohort B) Timolol Arm
Randomized, 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
Drug: Timolol eye drops 0.5%
timolol 0.5%
Period 3 (Cohort X) Gen 2 Travoprost Intracameral Implant Arm
Randomized, 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
Drug: Gen 2 Travoprost Intracameral Implant
travoprost
Period 3 (Cohort X) Timolol Arm
Randomized, 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
Drug: Timolol eye drops 0.5%
timolol 0.5%
Period 3 (Cohort Y) Gen 2 Travoprost Intracameral Implant Arm
Randomized, 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
Drug: Gen 2 Travoprost Intracameral Implant
travoprost
Period 3 (Cohort Y) Timolol Arm
Randomized, 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
Drug: Timolol eye drops 0.5%
timolol 0.5%
Period 3 (Cohort Z) Gen 2 Travoprost Intracameral Implant Arm
Randomized, 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
Drug: Gen 2 Travoprost Intracameral Implant
travoprost
Period 3 (Cohort Z) Timolol Arm
Randomized, 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
Drug: Timolol eye drops 0.5%
timolol 0.5%

Outcome Measures

Primary Outcome Measures
  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

Eligibility Criteria

Ages Eligible for Study(Adult, Older Adult)
Sexes Eligible for StudyAll
Accepts Healthy VolunteersNo
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

Contacts and Locations

Sponsors and CollaboratorsGlaukos Corporation
Locations
Glaukos Investigative Site | Grand Junction Colorado, United States, 81501Glaukos Investigative Site | Oklahoma City Oklahoma, United States, 73112Glaukos Clinical Site | El Paso Texas, United States, 79922
Investigators
Study Chair: Luis G. Vargas, MD, Glaukos Corporation