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NCT01052558 · ClinicalTrials.gov registry record · Phase 3

GTS400 Stent Implantation in Conjunction With Cataract Surgery in Subjects With Open-angle Glaucoma

A Phase 3 study, sponsored by Glaukos Corporation.

Completed
Registry status
Phase 3
Development phase
164
Enrollment target

NCT01052558: Completed Phase 3 study, sponsored by Glaukos Corporation.

NCT01052558 is a Phase 3 study that has completed, run by Glaukos Corporation. The registered enrollment target is 164 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (79% lower). According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT01052558, a Phase 3 study, has completed, sponsored by Glaukos Corporation.

COMPLETED
Registry status
Phase 3
Development phase
164 participants
Enrollment target

Study Summary

The purpose of this study is to evaluate the safety and efficacy of the GTS400 trabecular micro-bypass stent in reducing intraocular pressure (IOP) in subjects with open-angle glaucoma or ocular hypertension and co-existing cataract.

Interventions

  • PROCEDURE Cataract Surgery
  • DEVICE iStent Inject (GTS400)

Trial Details

FieldValue
Enrollment Target 164 participants
Start Date 2010-01
Est. Completion 2013-12
Phase Phase 3
Glaukos Corporation

33 total trials

What the finished NCT01052558 record still lists

NCT01052558 is an interventional study that assigns participants to a tested intervention. The registered 164 participants enrollment target is mid-sized for trials with a published cap, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (79% lower).

The record links to 0 conditions, and to 2 interventions - of which Cataract Surgery is the first listed.

NCT01052558 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT01052558 about?

NCT01052558 is a clinical study titled "GTS400 Stent Implantation in Conjunction With Cataract Surgery in Subjects With Open-angle Glaucoma". The purpose of this study is to evaluate the safety and efficacy of the GTS400 trabecular micro-bypass stent in reducing intraocular pressure (IOP) in subjects with open-angle glaucoma or ocular hypertension and co-existing cataract.

What is the current status of trial NCT01052558?

This trial is currently completed. It is a Phase 3 study. The enrollment target is 164 participants. The study started on 2010-01. Estimated completion is 2013-12.

What interventions are being tested in trial NCT01052558?

The interventions under investigation include: Cataract Surgery (PROCEDURE), iStent Inject (GTS400) (DEVICE).

Who is sponsoring clinical trial NCT01052558?

This trial is sponsored by Glaukos Corporation, which has 33 total clinical trials registered on ClinicalTrials.gov.

How this trial's enrollment target compares

Where NCT01052558's enrollment target sits among peer trials

164 1470th of 2000 higher than 530 of 2,000 other Phase 3 trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Phase 3 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.

Source ClinicalTrials.gov registry export · 2026-08-08

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Source: ClinicalTrials.gov NCT01052558, the US trial registry maintained by the National Library of Medicine. NCT01052558 (mid enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.