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

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Primary Purpose

Status

Completed

Phase

Phase 4

Locations

Armenia

Study Type

Interventional

Intervention

iStent inject

Travoprost

About this trial

This is an interventional treatment trial for Open-angle Glaucoma focused on measuring Open angle glaucoma, POAG, Ocular hypertension, Pseudoexfoliative glaucoma, Naïve to treatment

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

S.V. Malayan Ophthalmological Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Arm Label

iStent inject

Drug

Arm Description

Implantation of two iStent inject devices

Travoprost drops

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Change in mean diurnal IOP vs. screening

Change in screening in time-wise IOPs

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.

Full Information

NCT ID

NCT01444040

First Posted

September 28, 2011

Last Updated

September 2, 2022

Sponsor

Glaukos Corporation

1. Study Identification

Unique Protocol Identification Number

NCT01444040

Brief Title

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

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%

Study Type

Interventional

2. Study Status

Record Verification Date

September 2022

Overall Recruitment Status

Completed

Study Start Date

September 2011 (Actual)

Primary Completion Date

March 28, 2019 (Actual)

Study Completion Date

March 28, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Glaukos Corporation

4. Oversight

Data Monitoring Committee

No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Open-angle Glaucoma

Keywords

Open angle glaucoma, POAG, Ocular hypertension, Pseudoexfoliative glaucoma, Naïve to treatment

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 4

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

196 (Actual)

8. Arms, Groups, and Interventions

Arm Title

iStent inject

Arm Type

Active Comparator

Arm Description

Implantation of two iStent inject devices

Arm Title

Drug

Arm Type

Active Comparator

Arm Description

Travoprost drops

Intervention Type

Device

Intervention Name(s)

iStent inject

Intervention Description

Implantation of two iStent inject devices

Intervention Type

Drug

Intervention Name(s)

Travoprost

Intervention Description

Travoprost drops

Primary Outcome Measure Information:

Title

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

Time Frame

12 months

Secondary Outcome Measure Information:

Title

Change in mean diurnal IOP vs. screening

Time Frame

Month 24

Title

Change in screening in time-wise IOPs

Time Frame

Various Month 12-60

Title

Proportion of responders

Description

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.

Time Frame

Various 12-60 months

Other Pre-specified Outcome Measures:

Title

Adverse event reporting

Description

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

Time Frame

0-60 months

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

No

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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Lilit A Voskanyan, MD, PhD

Organizational Affiliation

S.V. Malayan Ophthalmological Center, Yerevan, Armenia

Official's Role

Principal Investigator

Facility Information:

Facility Name

S.V. Malayan Ophthalmological Center

City

Yerevan

ZIP/Postal Code

0001

Country

Armenia

Open-angle Glaucoma

About this trial

Eligibility Criteria

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

1. Study Identification

2. Study Status

3. Sponsor/Collaborators

4. Oversight

5. Study Description

6. Conditions and Keywords

7. Study Design

8. Arms, Groups, and Interventions

10. Eligibility

12. IPD Sharing Statement

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