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

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 Inject) or Travoprost Ophthalmic Solution 0.004%

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01444040
• Other study ID #: GCF-027
• Status: Completed
• Phase: Phase 4
• Start date: September 2011
• Est. completion date: March 28, 2019

Study information

• Verified date: September 2022
• Source: Glaukos Corporation
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 196
• Est. completion date: March 28, 2019
• Est. primary completion date: March 28, 2019
• 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 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

Related Conditions & MeSH terms

• Glaucoma
• Glaucoma, Open-Angle
• Hypertension
• Ocular Hypertension
• Open-angle Glaucoma

Intervention

Device:
• iStent inject
Implantation of two iStent inject 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, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Adverse event reporting	Rate of ocular adverse events through 60 months; Findings from IOP, best corrected visual acuity, visual field; Findings from slit-lamp, fundus and gonioscopic examinations	0-60 months
Primary	Change from screening in mean diurnal IOP (mm Hg) at the Month 12 visit.		12 months
Secondary	Change in mean diurnal IOP vs. screening		Month 24
Secondary	Change in screening in time-wise IOPs		Various Month 12-60
Secondary	Proportion of responders	A responder is defined as a subject with a certain target IOP value or a certain reduction of IOP as compared to screening. In the iStent inject group, a responder must not be on an ocular hypotensive medications or have had a postoperative procedure to reposition or remove stent(s) prior to the visit. Due to the lack of a complete consensus on the definition of a clinical responder, a set of target IOP values (e.g., downwards from 22 mm Hg in steps of 1 mm Hg) and reductions of IOP (e.g., downwards from the highest reduction in IOP in steps of 5%) will be evaluated.	Various 12-60 months