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

NCT02873806 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 53

Last updated 2022-09-07

No results posted yet for this study

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.

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

Sponsors & Collaborators

  • Glaukos Corporation

    lead INDUSTRY

Principal Investigators

  • Lilit Voskanyan, MD, PhD · S.V. Malayan Eye Center

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2013-03-31
Primary Completion
2019-11-08
Completion
2019-11-08

Countries

  • Armenia

Study Locations

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Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02873806 on ClinicalTrials.gov