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

Conditions

• Glaucoma

Eligibility Criteria

Sex

ALL

Age

18 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• Gen 2 Travoprost Intracameral Implant — DRUG
  travoprost
• Timolol eye drops 0.5% — DRUG
  timolol 0.5%
• Sham Procedure — PROCEDURE
  sham implant administration
• Placebo eye drops — OTHER
  artificial tears

Study Details

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

Key Dates

Start date

Jun 12, 2025

Status verified

Feb 2026

Primary completion

Mar 31, 2028

Completion

Mar 31, 2032

Study Design

Enrollment

610 participants (estimated)

Allocation

RANDOMIZED

Intervention model

SEQUENTIAL

Primary purpose

TREATMENT

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

Primary Outcome Measure

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

Central Contacts

• Study Director
  949-739-8749
  [email protected]

Locations (3)

Find similar trials in Grand Junction, CO

Related Studies

• Evaluation of the Safety and Efficacy of the Bimatoprost Implant System Used in Combination With the SpyGlass IOL Compared to Timolol Ophthalmic Solution (Rhine)
  PHASE3 · Recruiting · SpyGlass Pharma, Inc. · Houston, Texas
• Evaluation of the Safety and Efficacy of the Bimatoprost Implant System Used in Combination With the SpyGlass IOL Compared to Timolol Ophthalmic Solution (Rhone)
  PHASE3 · Recruiting · SpyGlass Pharma, Inc. · San Antonio, Texas
• Change in IOP Fluctuation After DSLT
  Recruiting · Ophthalmology Associates, Fort Worth · Fort Worth, Texas
• Rocklatan vs Latanoprost Post-DSLT
  PHASE4 · Recruiting · Eye Centers of Southeast Texas · Beaumont, Texas