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

March 25, 2026 updated by: Glaukos Corporation

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

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

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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

Study Type

Interventional

Enrollment (Estimated)

510

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Diagnosis of Ocular Hypertension or Open-Angle Glaucoma 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 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
Other Names:
  • Gen 2 Travoprost Intraocular Implant
Other: placebo eye drops
Artificial Tears
Active Comparator: 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%
Other Names:
  • Timolol maleate ophthalmic solution, 0.5%
Procedure: Sham Procedure
Sham implant administration
Active Comparator: 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
Other Names:
  • Gen 2 Travoprost Intraocular Implant
Other: placebo eye drops
Artificial Tears
Active Comparator: 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%
Other Names:
  • Timolol maleate ophthalmic solution, 0.5%
Procedure: Sham Procedure
Sham implant administration
Experimental: 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
Other Names:
  • Gen 2 Travoprost Intraocular Implant
Other: placebo eye drops
Artificial Tears
Active Comparator: 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%
Other Names:
  • Timolol maleate ophthalmic solution, 0.5%
Procedure: Sham Procedure
Sham implant administration

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Intraocular pressure (IOP)
Time Frame: 3 months
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Glaukos Corporation

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 17, 2026

Primary Completion (Estimated)

June 1, 2028

Study Completion (Estimated)

March 1, 2032

Study Registration Dates

First Submitted

March 23, 2026

First Submitted That Met QC Criteria

March 23, 2026

First Posted (Actual)

March 27, 2026

Study Record Updates

Last Update Posted (Actual)

March 30, 2026

Last Update Submitted That Met QC Criteria

March 25, 2026

Last Verified

March 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • GLK-102-02

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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