NCT02873806

Two Trabecular Micro-bypass Stents & Postoperative Travoprost to Treat Glaucoma Subjects on Two Hypotensive Agents

A Prospective Evaluation of Open-angle Glaucoma Subjects on Two Topical Hypotensive Medications (One a Prostaglandin) Treated With Two Trabecular Micro-bypass Stents (iStent Inject) and a Postoperative Topical Prostaglandin

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 53 (actual)
• Sponsor: Glaukos Corporation · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The study objective was to evaluate the intraocular pressure (IOP) lowering effect of two iStent devices in eyes of subjects with primary open-angle glaucoma, washed out of two anti-glaucoma medications (one a Prostaglandin) prior to stent implantation.

Detailed description

The study design is as follows: * Prospective, single-arm study. * Subjects with open-angle glaucoma and medicated IOP \> 18 mmHg and ≤ 30 mmHg. * Subjects on two topical ocular hypotensive medications (one a prostaglandin). * Implantation of two iStent inject devices (if IOP is \< 6 mmHg, at any point during the postoperative follow-up, medication will not be prescribed or will be discontinued). * IOP will be measured by two (2) observers to minimize bias; observer 1 will look through the slit lamp and turn the dial with readings being masked, and observer 2 will document the IOP. * Follow-up through 60 months postoperative (or up to 61 months if subject needs to undergo terminal washout). * Descriptive statistics will be tabulated. * Medical therapy considered necessary for the subject's welfare can be implemented at any time during the study at the investigator's discretion.

Conditions

• Open-angle Glaucoma

Interventions

Type	Name	Description
PROCEDURE	Implantation of two iStent inject micro-bypass stents	\- Implantation of two trabecular micro-bypass stents (iStent inject) in a standalone procedure (i.e., without cataract surgery).
DRUG	Topical travoprost	\- Topical travoprost (0.004%, 1 drop each evening in study eye) started on postoperative Day 1.
DEVICE	Two iStent inject micro-bypass stents	\- Two trabecular micro-bypass stents (iStent inject) implanted in a standalone procedure.
DRUG	Tobramycin	Topical antibiotic (tobramycin): 1 drop four (4) times per day in the study eye for one week (in cases of allergy or contraindication, Polytrim (polymyxin B sulfate + trimethoprim sulfate ophthalmic solution, USP, or equivalent) may be used as an alternative medication) .
DRUG	Dexamethasone	Topical anti-inflammatory medication (dexamethasone ophthalmic suspension 0.1%): * Week 1: 1 drop four (4) times per day in the study eye * Week 2: 1 drop three (3) times per day in the study eye * Week 3: 1 drop two (2) times per day in the study eye * Week 4: 1 drop one (1) time per day in the study eye

Timeline

• Start date: 2013-03-01
• Primary completion: 2019-11-08
• Completion: 2019-11-08
• First posted: 2016-08-22
• Last updated: 2022-09-07

Locations

1 site across 1 country: Armenia