Phase 2 Trial to Evaluate the Safety and Efficacy of the Second Generation Travoprost Intracameral Implant
Trial Snapshot
- Phase
- Phase 2
- Status
- Recruiting
- Sponsor
- Glaukos Corporation
- Enrollment
- 110
- Locations
- 5
- Primary Endpoint
- Intraocular pressure (IOP)
Study Overview
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 Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Sequential
- Primary Purpose
- Treatment
- Masking
- Triple (Participant, Investigator, Outcomes Assessor)
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Arms & Interventions
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
Intervention: Gen 2 Travoprost Intracameral Implant (Drug)
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
Intervention: Gen 2 Travoprost Intracameral Implant (Drug)
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
Intervention: Placebo eye drops (Other)
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
Intervention: Timolol eye drops 0.5% (Drug)
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
Intervention: Sham Procedure (Procedure)
Outcomes
Primary Outcomes
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
Secondary Outcomes
No secondary outcomes reported