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

ConditionGlaucoma

Trial statusRecruiting

Trial phasePhase 2

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 volunteers

Qualifiers

Diagnosis of open-angle glaucoma or ocular hypertension 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

Sequential

Treatments tested in this trial

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

Treatment groups

110 Participants

are divided into 3 treatment groups

Group A: Period 1 (Cohort A)Experimental treatment 1 intervention

Group B: Period 2 (Cohort B) Gen 2 Travoprost Intracameral Implant ArmExperimental treatment 2 interventions

Group C: Period 2 (Cohort B) Timolol ArmActive comparator 2 interventions

Trial outcomes

Primary outcomes

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 months

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Glaukos Corporation

Lead sponsor

Source ClinicalTrials.gov

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