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

Part of paid clinical trials in Dothan, Alabama.

Sponsor
Glaukos Corporation
Study ID
NCT07495852
Phase
PHASE3
Status
Recruiting
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Conditions

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
Feb 17, 2026
Status verified
Mar 2026
Primary completion
Jun 30, 2028
Completion
Mar 31, 2032

Study Design

Enrollment
510 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: 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: 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: 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: 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: 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: 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

Locations (1)

FacilityCityStateZIPSite coordinators
Glaukos Investigative SiteDothanAlabama36301
Luis Vargas, MD
[email protected]
949-739-8749

Find similar trials in Dothan, AL

By condition
Glaucoma
By specialty
Ophthalmology
By research site
Glaukos Investigative Site· Dothan, AL

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