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

Glaukos

Status and phase: Enrolling; Phase 3; Phase 2

Conditions: Glaucoma

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

Study type: Interventional

Funder types: Industry

Identifiers

NCT07075718

GLK-102-01

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: 610 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Sequential Assignment

Masking: Triple Blind

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610 participants in 9 patient groups

Period 1 (Cohort A)

Experimental group

Description:

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

Treatment:

Drug: Gen 2 Travoprost Intracameral Implant

Period 2 (Cohort B) Gen 2 Travoprost Intracameral Implant Arm

Experimental group

Description:

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

Treatment:

Other: Placebo eye drops

Drug: Gen 2 Travoprost Intracameral Implant

Period 2 (Cohort B) Timolol Arm

Active Comparator group

Description:

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

Treatment:

Drug: Timolol eye drops 0.5%

Procedure: Sham Procedure

Period 3 (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:

Other: Placebo eye drops

Drug: Gen 2 Travoprost Intracameral Implant

Period 3 (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

Period 3 (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:

Other: Placebo eye drops

Drug: Gen 2 Travoprost Intracameral Implant

Period 3 (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

Period 3 (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

Period 3 (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:

Other: Placebo eye drops

Drug: Timolol eye drops 0.5%