NCT01444040

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
196

participants targeted

Target at P50-P75 for phase_4

Timeline
Completed

Started Sep 2011

Longer than P75 for phase_4

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2011

Completed
27 days until next milestone

First Submitted

Initial submission to the registry

September 28, 2011

Completed
2 days until next milestone

First Posted

Study publicly available on registry

September 30, 2011

Completed
7.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 28, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 28, 2019

Completed
Last Updated

September 8, 2022

Status Verified

September 1, 2022

Enrollment Period

7.6 years

First QC Date

September 28, 2011

Last Update Submit

September 2, 2022

Conditions

Open-angle Glaucoma

Keywords

Open angle glaucomaPOAGOcular hypertensionPseudoexfoliative glaucomaNaïve to treatment

Outcome Measures

Primary Outcomes (1)

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

    12 months

Secondary Outcomes (3)

  • 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

Other Outcomes (1)

  • Adverse event reporting

    0-60 months

Study Arms (2)

iStent inject

ACTIVE COMPARATOR

Implantation of two iStent inject devices

Device: iStent inject

Drug

ACTIVE COMPARATOR

Travoprost drops

Drug: Travoprost

Interventions

iStent injectDEVICE

Implantation of two iStent inject devices

iStent inject
TravoprostDRUG

Travoprost drops

Drug

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

S.V. Malayan Ophthalmological Center

Yerevan, 0001, Armenia

Location

MeSH Terms

Conditions

Glaucoma, Open-AngleOcular Hypertension

Interventions

Travoprost

Condition Hierarchy (Ancestors)

GlaucomaEye Diseases

Intervention Hierarchy (Ancestors)

CloprostenolProstaglandins F, SyntheticProstaglandins, SyntheticProstaglandinsEicosanoidsFatty Acids, UnsaturatedFatty AcidsLipidsAutacoidsInflammation MediatorsBiological Factors

Study Officials

  • Lilit A Voskanyan, MD, PhD

    S.V. Malayan Ophthalmological Center, Yerevan, Armenia

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 28, 2011

First Posted

September 30, 2011

Study Start

September 1, 2011

Primary Completion

March 28, 2019

Study Completion

March 28, 2019

Last Updated

September 8, 2022

Record last verified: 2022-09

Locations

AR(1)