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Recruiting NCT07075718

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

Phase II / Phase III Interventional Glaucoma

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Gen 2 Travoprost Intracameral Implant, Timolol eye drops 0.5%, Sham Procedure, Placebo eye drops.
Who it may be relevant to
Registry conditions: Glaucoma. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Overview

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

Interventions

  • Drug Gen 2 Travoprost Intracameral Implant
    travoprost
  • Drug Timolol eye drops 0.5%
    timolol 0.5%
  • Procedure Sham Procedure
    sham implant administration
  • Other Placebo eye drops
    artificial tears

Primary outcome measures

  • Intraocular pressure (IOP) [Time frame: 3 months]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Sequential
Masking
Triple blind
Primary purpose
Treatment

Study locations

United States · 3 centers
  • Glaukos Investigative Site — Grand Junction
  • Glaukos Investigative Site — Oklahoma City
  • Glaukos Clinical Site — El Paso

Identifiers

NCT: NCT07075718 · GLK-102-01

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗