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

• Sponsor: Glaukos Corporation (Industry)
• Overall Status: Completed
• CT.gov ID: NCT01443988
• Collaborator: (none)
• Enrollment: 101
• Location: 1
• Arms: 2
• Actual Duration (Months): 67
• Patients Per Site Per Month: 1.5

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Open-angle Glaucoma	Device: iStent; Drug: Travoprost	Phase 4

Detailed 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.

Study Design

• Study Type: Interventional
• Actual Enrollment: 101 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• 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%
• Actual Study Start Date: Sep 1, 2011
• Actual Primary Completion Date: Jan 1, 2017
• Actual Study Completion Date: Apr 1, 2017

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: iStent Implantation of two iStent devices	Device: iStent; Implantation of two iStent devices
Active Comparator: Drug Travoprost drops	Drug: Travoprost; Travoprost drops

Outcome Measures

Primary Outcome Measures

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

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	S.V. Malayan Ophthalmological Center	Yerevan		Armenia	0001

Sponsors and Collaborators

• Glaukos Corporation

Investigators

• Principal Investigator: Lilit A Voskanyan, MD, PhD, S.V. Malayan Ophthalmological Center, Yerevan, Armenia

Study Documents (Full-Text)

None provided.

More Information

Publications

• 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.

• Responsible Party: Glaukos Corporation
• ClinicalTrials.gov Identifier: NCT01443988
• Other Study ID Numbers: GCF-022
• First Posted: Sep 30, 2011
• Last Update Posted: Dec 18, 2017
• Last Verified: Dec 1, 2017

• Keywords provided by Glaukos Corporation: Open angle glaucoma; POAG; Ocular hypertension; Pseudoexfoliative glaucoma; Naïve to treatment
• Additional relevant MeSH terms: Glaucoma; Glaucoma, Open-Angle; Ocular Hypertension; Hypertension; Travoprost

Study Results

No Results Posted as of Dec 18, 2017