Recruiting
Phase 2
Phase 3

Travoprost

Sponsor:

Glaukos Corporation

Code:

NCT07075718

Conditions

Glaucoma

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Gen 2 Travoprost Intracameral Implant

Timolol eye drops 0.5%

Sham Procedure

Placebo eye drops

Study Details

Brief summary:

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

Conditions

Glaucoma

Study ID

NCT07075718

Start date

Jun 12, 2025

Status verified date

Feb, 2026

Completion date

Mar, 2032

Anticipated

Primary completion date

Mar, 2028

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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

Enrollment

610 participants

Anticipated

Allocation

Randomized

Intervention Model

Sequential

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: 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

experimental: 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

active comparator: 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

experimental: 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

active comparator: 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

active comparator: 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

active comparator: 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

experimental: 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

active comparator: 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

Interventions

Gen 2 Travoprost Intracameral Implant

travoprost

Timolol eye drops 0.5%

timolol 0.5%

Sham Procedure

sham implant administration

Placebo eye drops

artificial tears

Primary outcome measure

  • Intraocular pressure (IOP) [ Time Frame: 3 months ]

Central Contacts and Locations

Central contacts

Study Director

949-739-8749ClinicalResearch@glaukos.com

Locations

Glaukos Investigative Site

Recruiting

Grand Junction, Colorado, United States, 81501

Contacts

Study Coordinator

949-739-8749ClinicalResearch@glaukos.com

Glaukos Investigative Site

Recruiting

Oklahoma City, Oklahoma, United States, 73112

Contacts

Study Coordinator

949-739-8749ClinicalResearch@glaukos.com

Glaukos Clinical Site

Recruiting

El Paso, Texas, United States, 79922

Contacts

Study Coordinator

949-739-8749ClinicalResearch@glaukos.com

More Information

Sponsor

Glaukos Corporation

Last update posted

Mar 2, 2026

Last verified

Feb, 2026

Keywords

  • open-angle glaucoma
  • ocular hypertension

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Glaukos Corporation on 2026-03-02.