Phase 2/Phase 3 Trial to Evaluate the Safety and Efficacy of the Second Generation Travoprost Intracameral Implant
NCT ID: NCT07075718
Last Updated: 2025-07-22
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE2/PHASE3
610 participants
INTERVENTIONAL
2025-06-12
2032-03-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
SEQUENTIAL
TREATMENT
TRIPLE
Study Groups
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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
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
Gen 2 Travoprost Intracameral Implant
travoprost
Placebo eye drops
artificial tears
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
Timolol eye drops 0.5%
timolol 0.5%
Sham Procedure
sham implant administration
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
Gen 2 Travoprost Intracameral Implant
travoprost
Placebo eye drops
artificial tears
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
Timolol eye drops 0.5%
timolol 0.5%
Sham Procedure
sham implant administration
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
Gen 2 Travoprost Intracameral Implant
travoprost
Placebo eye drops
artificial tears
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
Timolol eye drops 0.5%
timolol 0.5%
Sham Procedure
sham implant administration
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
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
Timolol eye drops 0.5%
timolol 0.5%
Placebo eye drops
artificial tears
Interventions
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Gen 2 Travoprost Intracameral Implant
travoprost
Timolol eye drops 0.5%
timolol 0.5%
Sham Procedure
sham implant administration
Placebo eye drops
artificial tears
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
* Prior argon laser trabeculoplasty (ALT) in the study eye
* Prior minimally invasive glaucoma (MIGS) surgery in the study eye
18 Years
ALL
No
Sponsors
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Glaukos Corporation
INDUSTRY
Responsible Party
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Principal Investigators
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Luis G. Vargas, MD
Role: STUDY_CHAIR
Glaukos Corporation
Locations
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Glaukos Investigative Site
Grand Junction, Colorado, United States
Glaukos Investigative Site
Oklahoma City, Oklahoma, United States
Glaukos Clinical Site
El Paso, Texas, United States
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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GLK-102-01
Identifier Type: -
Identifier Source: org_study_id
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