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

Glaukos

Status and phase: Enrolling; Phase 3

Conditions: Glaucoma

Treatments: Procedure: Sham Procedure; Other: placebo eye drops; Drug: Timolol eye drops 0.5%; Drug: Gen 2 Travoprost Intracameral Implant

Study type: Interventional

Funder types: Industry

Identifiers

NCT07495852

GLK-102-02

Details and patient eligibility

About

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

Full 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

Enrollment: 510 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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510 participants in 6 patient groups

Cohort X Gen 2 Travoprost Intracameral Implant Arm

Experimental group

Description:

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

Treatment:

Drug: Gen 2 Travoprost Intracameral Implant

Other: placebo eye drops

Cohort X Timolol Arm

Active Comparator group

Description:

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

Treatment:

Drug: Timolol eye drops 0.5%

Procedure: Sham Procedure

Cohort Y Gen 2 Travoprost Intracameral Implant Arm

Active Comparator group

Description:

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

Treatment:

Drug: Gen 2 Travoprost Intracameral Implant

Other: placebo eye drops

Cohort Y Timolol Arm

Active Comparator group

Description:

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

Treatment:

Drug: Timolol eye drops 0.5%

Procedure: Sham Procedure

Cohort Z Gen 2 Travoprost Intracameral Implant Arm

Experimental group

Description:

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

Treatment:

Drug: Gen 2 Travoprost Intracameral Implant

Other: placebo eye drops

Cohort Z Timolol Arm

Active Comparator group

Description:

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

Treatment:

Drug: Timolol eye drops 0.5%

Procedure: Sham Procedure