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

NCT07495852 | Recruiting Phase 3 FDA Drug

• 1 other identifier: GLK-102-02
• Study Type: interventional
• Target: 510
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Glaucoma

Keywords

Open Angle Glaucoma; Ocular hypertension

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 (6)

Cohort X Gen 2 Travoprost Intracameral Implant Arm

EXPERIMENTAL

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; Other: placebo eye drops

Cohort X Timolol Arm

ACTIVE COMPARATOR

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%; Procedure: Sham Procedure

Cohort Y Gen 2 Travoprost Intracameral Implant Arm

ACTIVE COMPARATOR

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; Other: placebo eye drops

Cohort Y Timolol Arm

ACTIVE COMPARATOR

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%; Procedure: Sham Procedure

Cohort Z Gen 2 Travoprost Intracameral Implant Arm

EXPERIMENTAL

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; Other: placebo eye drops

Cohort Z Timolol Arm

ACTIVE COMPARATOR

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%; Procedure: Sham Procedure

Interventions

Gen 2 Travoprost Intracameral Implant DRUG

Travoprost

Also known as: Gen 2 Travoprost Intraocular Implant

Cohort X Gen 2 Travoprost Intracameral Implant Arm; Cohort Y Gen 2 Travoprost Intracameral Implant Arm; Cohort Z Gen 2 Travoprost Intracameral Implant Arm

Timolol eye drops 0.5% DRUG

Timolol 0.5%

Also known as: Timolol maleate ophthalmic solution, 0.5%

Cohort X Timolol Arm; Cohort Y Timolol Arm; Cohort Z Timolol Arm

Sham Procedure PROCEDURE

Sham implant administration

Cohort X Timolol Arm; Cohort Y Timolol Arm; Cohort Z Timolol Arm

placebo eye drops OTHER

Artificial Tears

Cohort X Gen 2 Travoprost Intracameral Implant Arm; Cohort Y Gen 2 Travoprost Intracameral Implant Arm; Cohort Z Gen 2 Travoprost Intracameral Implant Arm

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Diagnosis of Ocular Hypertension or Open-Angle Glaucoma 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

Sponsors & Collaborators

• Glaukos Corporation: lead

Study Sites (1)

Glaukos Investigative Site

Dothan, Alabama, 36301, United States

RECRUITING

MeSH Terms

Conditions

Glaucoma; Glaucoma, Open-Angle; Ocular Hypertension

Condition Hierarchy (Ancestors)

Eye Diseases

Central Study Contacts

Study Director

CONTACT

949-739-8749; ClinicalResearch@glaukos.com

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: The study is double-masked in which treatments will be unknown to the subject and to the site staff performing certain outcome measurements
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Subjects will be randomized to undergo initial implant of an intracameral implant and prescription of artificial tears or a sham procedure and prescription of timolol. Subjects will be assessed for eligibility for an exchange procedure at 12, 24 or 36 months and followed for an additional 12 months

Study Record Dates

• First Submitted: March 23, 2026
• First Posted: March 27, 2026
• Study Start: February 17, 2026
• Primary Completion (Estimated): June 1, 2028
• Study Completion (Estimated): March 1, 2032
• Last Updated: March 30, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)