Trial to Evaluate the Safety and Efficacy of the Second Generation Travoprost Intracameral Implant
ConditionGlaucoma
Trial statusRecruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age18+
SponsorGlaukos Corporation
About this trial
Evaluate the Safety and Efficacy of the Second Generation Travoprost Intracameral Implant
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Diagnosis of Ocular Hypertension or Open-Angle Glaucoma in the study eye
Disqualifiers
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
Design model
Parallel
Treatments tested in this trial
Gen 2 Travoprost Intracameral Implant
DrugTravoprost
Timolol eye drops 0.5%
DrugTimolol 0.5%
Sham Procedure
Procedure/SurgerySham implant administration
placebo eye drops
Other interventionArtificial Tears
Treatment groups
510 Participants
are divided into 6 treatment groups6
Treatment groupsSee each treatment group below.
Group A: Cohort X Gen 2 Travoprost Intracameral Implant ArmExperimental treatment 2 interventions
Group B: Cohort X Timolol ArmActive comparator 2 interventions
Group C: Cohort Y Gen 2 Travoprost Intracameral Implant ArmActive comparator 2 interventions
Group D: Cohort Y Timolol ArmActive comparator 2 interventions
Group E: Cohort Z Gen 2 Travoprost Intracameral Implant ArmExperimental treatment 2 interventions
Group F: Cohort Z Timolol ArmActive comparator 2 interventions
Trial outcomes
Primary outcomes
1
Intraocular pressure (IOP)
Change from baseline in diurnal IOP in the study eye at 8am and 10am at each of Day 11, Week 6, and Month 3 visits
Time frame
3 monthsSponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov