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Clinical Trials/NCT01444040
NCT01444040
Completed
Phase 4

A Prospective, Randomized Evaluation of Subjects With Open-angle Glaucoma, Pseudoexfoliative Glaucoma, or Ocular Hypertension Naïve to Medical and Surgical Therapy, Treated With Two Trabecular Micro-bypass Stents (iStent Inject) or Travoprost Ophthalmic Solution 0.004%

Glaukos Corporation1 site in 1 country196 target enrollmentSeptember 2011
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ConditionsOpen-angle Glaucoma
InterventionsTravoprostiStent inject
DrugsTravoprost

Overview

Phase
Phase 4
Intervention
Travoprost
Conditions
Open-angle Glaucoma
Sponsor
Glaukos Corporation
Enrollment
196
Locations
1
Primary Endpoint
Change from screening in mean diurnal IOP (mm Hg) at the Month 12 visit.
Status
Completed
Last Updated
3 years ago
OverviewInvestigatorsEligibility CriteriaArms & InterventionsOutcomesSitesSimilar Trials

Overview

Brief Summary

Evaluation of the intraocular pressure (IOP) lowering effect of two iStent inject devices versus medical therapy in eyes of subjects with primary open-angle glaucoma, pseudoexfoliative glaucoma, or ocular hypertension naïve to medical and surgical therapy.

Detailed Description

Evaluation of the intraocular pressure (IOP) lowering effect of two iStent inject devices versus medical therapy in eyes of subjects with primary open-angle glaucoma, pseudoexfoliative glaucoma, or ocular hypertension naïve to medical and surgical therapy.

Registry
clinicaltrials.gov
Start Date
September 2011
End Date
March 28, 2019
Last Updated
3 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

  • •Phakic study eye
  • •IOP ≥ 21 mmHg and ≤ 40 mmHg at the screening visit (subjects with OHT require a second screening IOP measurement

Exclusion Criteria

  • •Aphakic or pseudophakic eyes (AC-IOLs or PC-IOLs)
  • •Previous usage of topical prostaglandin analogues or prior medical therapy for glaucoma

Arms & Interventions

Drug

Travoprost drops

Intervention: Travoprost

iStent inject

Implantation of two iStent inject devices

Intervention: iStent inject

Outcomes

Primary Outcomes

Change from screening in mean diurnal IOP (mm Hg) at the Month 12 visit.

Time Frame: 12 months

Secondary Outcomes

  • Change in mean diurnal IOP vs. screening(Month 24)
  • Change in screening in time-wise IOPs(Various Month 12-60)
  • Proportion of responders(Various 12-60 months)

Study Sites (1)

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