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

PHASE4CompletedINTERVENTIONAL
Enrollment

53

Participants

Timeline

Start Date

March 31, 2013

Primary Completion Date

November 8, 2019

Study Completion Date

November 8, 2019

Conditions
Open-angle Glaucoma
Interventions
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"

Trial Locations (1)

375108

S.V. Malayan's Ophtalmology Centre, Yerevan

Sponsors
All Listed Sponsors
lead

Glaukos Corporation

INDUSTRY