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

Not Applicable

Recruiting

• Conditions: Glaucoma
• Interventions: Drug: Gen 2 Travoprost Intracameral Implant; Drug: Timolol eye drops 0.5%; Other: Placebo eye drops; Procedure: Sham Procedure

• Registration Number: NCT07075718
• Lead Sponsor: Glaukos Corporation

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

Study Timeline

• Study Start: 2025-06-12
• Status Verified: 2025-07
• Study First Submitted: 2025-07-10
• Study First Submitted QC: 2025-07-10
• Last Update Submitted: 2025-07-18
• Study First Posted: 2025-07-20
• Last Update Posted: 2025-07-22
• Primary Completion: 2028-03
• Study Completion: 2032-03-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 610

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SEQUENTIAL

Arm && Interventions

Group	Intervention	Description
Period 1 (Cohort A)	Gen 2 Travoprost Intracameral Implant	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
Period 2 (Cohort B) Gen 2 Travoprost Intracameral Implant Arm	Placebo eye drops	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
Period 2 (Cohort B) Timolol Arm	Timolol eye drops 0.5%	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
Period 3 (Cohort X) Gen 2 Travoprost Intracameral Implant Arm	Gen 2 Travoprost Intracameral Implant	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
Period 3 (Cohort X) Gen 2 Travoprost Intracameral Implant Arm	Placebo eye drops	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
Period 3 (Cohort X) Timolol Arm	Timolol eye drops 0.5%	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
Period 3 (Cohort X) Timolol Arm	Sham Procedure	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
Period 3 (Cohort Y) Gen 2 Travoprost Intracameral Implant Arm	Gen 2 Travoprost Intracameral Implant	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
Period 3 (Cohort Y) Gen 2 Travoprost Intracameral Implant Arm	Placebo eye drops	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
Period 2 (Cohort B) Gen 2 Travoprost Intracameral Implant Arm	Gen 2 Travoprost Intracameral Implant	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
Period 2 (Cohort B) Timolol Arm	Sham Procedure	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
Period 3 (Cohort Y) Timolol Arm	Timolol eye drops 0.5%	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
Period 3 (Cohort Y) Timolol Arm	Sham Procedure	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
Period 3 (Cohort Z) Gen 2 Travoprost Intracameral Implant Arm	Gen 2 Travoprost Intracameral Implant	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
Period 3 (Cohort Z) Timolol Arm	Timolol eye drops 0.5%	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
Period 3 (Cohort Z) Timolol Arm	Placebo eye drops	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

Primary Outcome Measures

Name	Time	Method
Intraocular pressure (IOP)	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

Trial Locations

Locations (2)

Glaukos Investigative Site; 🇺🇸 Oklahoma City, Oklahoma, United States

Glaukos Clinical Site; 🇺🇸 El Paso, Texas, United States