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NCT01443988 Clinical Trial

Subjects With Open-angle Glaucoma, Pseudoexfoliative Glaucoma, or Ocular Hypertension Naïve to Medical and Surgical Therapy, Treated With Two Trabecular Micro-bypass Stents (iStent)or Travoprost

Open-angle Glaucoma Clinical Trial

Official title:
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) or Travoprost Ophthalmic Solution 0.004%

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT01443988
Other study ID # GCF-022
Secondary ID
Status Completed
Phase Phase 4
First received September 28, 2011
Last updated December 14, 2017
Start date September 2011
Est. completion date April 2017

Study information
Verified date December 2017
Source Glaukos Corporation
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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

Description:

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

Recruitment information / eligibility
Status Completed
Enrollment 101
Est. completion date April 2017
Est. primary completion date January 2017
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria:

- Phakic study eye

- IOP = 21 mmHg and = 40 mmHg at screening exam (OHT requires second screening)

Exclusion Criteria:

- Aphakic or pseudophakic eyes (AC-IOLs or PC-IOLs)

- Previous usage of topical prostaglandin analogues or prior medical therapy for glaucoma

Study Design

Related Conditions & MeSH terms

Intervention

Device:
• iStent
Implantation of two iStent devices
Drug:
• Travoprost
Travoprost drops

Locations
Country Name City State
Armenia S.V. Malayan Ophthalmological Center Yerevan

Sponsors (1)
Lead Sponsor Collaborator
Glaukos Corporation

Country where clinical trial is conducted

Armenia, 

References & Publications (1)

Vold SD, Voskanyan L, Tetz M, Auffarth G, Masood I, Au L, Ahmed II, Saheb H. Newly Diagnosed Primary Open-Angle Glaucoma Randomized to 2 Trabecular Bypass Stents or Prostaglandin: Outcomes Through 36 Months. Ophthalmol Ther. 2016 Dec;5(2):161-172. Epub 2016 Sep 12. Erratum in: Ophthalmol Ther. 2016 Dec;5(2):173. — View Citation

Outcome
Type Measure Description Time frame Safety issue
Primary Change from screening in mean diurnal IOP (mm Hg) at the Month 12 visit. 12 months
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