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

NCT07495852 — Phase 3, Recruiting, 510 participants, Glaukos Corporation

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

Registry	NCT07495852
Status	Recruiting
Phase	Phase 3
Study type	Interventional; randomized, parallel, masking: triple, treatment
Enrollment	510 (Estimated)
Sponsor	Glaukos Corporation (Industry)
Conditions	Glaucoma
Interventions	Gen 2 Travoprost Intracameral Implant, Timolol eye drops 0.5%, Sham Procedure, placebo eye drops (Drug, procedure, other)
Dates	start 2026-02-17, primary completion 2028-06-01 (estimated), completion 2032-03-01 (estimated), first posted 2026-03-27, last updated 2026-03-30
Locations	1 site in United States

-Summary

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

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+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

+Arms and interventions

Arm	Type	Interventions	Description
Cohort X Gen 2 Travoprost Intracameral Implant Arm	Experimental	Drug: Gen 2 Travoprost Intracameral Implant; Other: 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
Cohort X Timolol Arm	Active comparator	Drug: Timolol eye drops 0.5%; Procedure: 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
Cohort Y Gen 2 Travoprost Intracameral Implant Arm	Active comparator	Drug: Gen 2 Travoprost Intracameral Implant; Other: 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
Cohort Y Timolol Arm	Active comparator	Drug: Timolol eye drops 0.5%; Procedure: 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
Cohort Z Gen 2 Travoprost Intracameral Implant Arm	Experimental	Drug: Gen 2 Travoprost Intracameral Implant; Other: 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 36 and be followed for an additional 12 months
Cohort Z Timolol Arm	Active comparator	Drug: Timolol eye drops 0.5%; Procedure: 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 an sham exchange procedure at month 36 and be followed for an additional 12 months

Gen 2 Travoprost Intracameral Implant (Drug), also known as Gen 2 Travoprost Intraocular Implant: Travoprost
Timolol eye drops 0.5% (Drug), also known as Timolol maleate ophthalmic solution, 0.5%: Timolol 0.5%
Sham Procedure (Procedure): Sham implant administration
placebo eye drops (Other): Artificial Tears

+Outcome measures

Primary outcomes

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

+Eligibility

Sex: All, ages: 18 Years to any

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

+Locations (1)

Facility	City	Country	Status
Glaukos Investigative Site	Dothan, Alabama	United States	Recruiting