NCT01735214

Brief Summary

This study is a prospective, observational study of changing from any IOP-lowering treatment to a prostaglandin analogue-containing IOP-lowering medication for patients with Primary Open Angle Glaucoma (POAG) or Ocular Hypertension (OHT). The decision to change medications lies with the physician according to their standard practice.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
358

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Mar 2013

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

First Submitted

Initial submission to the registry

November 26, 2012

Completed
2 days until next milestone

First Posted

Study publicly available on registry

November 28, 2012

Completed
3 months until next milestone

Study Start

First participant enrolled

March 7, 2013

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 10, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 10, 2014

Completed
1 year until next milestone

Results Posted

Study results publicly available

April 27, 2015

Completed
Last Updated

April 18, 2019

Status Verified

April 1, 2019

Enrollment Period

1.1 years

First QC Date

November 26, 2012

Results QC Date

April 10, 2015

Last Update Submit

April 9, 2019

Conditions

Glaucoma, Open-AngleOcular Hypertension

Outcome Measures

Primary Outcomes (2)

  • Change From Baseline in Intraocular Pressure (IOP) in the Right Eye

    IOP is a measurement of the fluid pressure inside the eye. A negative change from Baseline indicates an improvement.

    Baseline, Week 12

  • Change From Baseline in Intraocular Pressure (IOP) in the Left Eye

    IOP is a measurement of the fluid pressure inside the eye. A negative change from Baseline indicates an improvement.

    Baseline, Week 12

Secondary Outcomes (7)

  • Patient Assessment of Overall Tolerability With New Treatment Using a 4-Point Scale

    12 Weeks

  • Physician Assessment of Tolerability With New Treatment Using a 4-Point Scale

    12 Weeks

  • Percentage of Participants Who Discontinue the Use of New Treatment Prior to 12 Weeks

    12 Weeks

  • Percentage of Participants Who Continue the New Treatment After 12 Weeks

    12 Weeks

  • Physician Assessment of Adherence to New Treatment Using a 4-Point Scale

    12 Weeks

  • +2 more secondary outcomes

Study Arms (1)

Patients with POAG or OHT

Patients with POAG or OHT on current IOP-lowering therapy who are prescribed a prostaglandin analogue -containing IOP-lowering therapy by the physician. The decision to prescribe a change in IOP-lowering therapy lies with the physician according to their standard practice.

Drug: Prostaglandin Analogue -Containing IOP-Lowering Therapy

Interventions

Prostaglandin Analogue -Containing IOP-Lowering TherapyDRUG

Patients with POAG or OHT on current IOP-lowering therapy who are prescribed a prostaglandin analogue -containing IOP-lowering therapy by the physician. The decision to prescribe a change in IOP-lowering therapy lies with the physician according to their standard practice.

Patients with POAG or OHT

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

POAG or OHT

You may qualify if:

  • Diagnosis of primary open angle glaucoma (POAG) or ocular hypertension (OHT)
  • Previously prescribed any IOP-lowering therapy which has been stopped and a new prostaglandin analogue -containing IOP-lowering therapy started

You may not qualify if:

  • None

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Unknown Facility

Istanbul, Turkey (Türkiye)

Location

Related Publications (1)

  • Tamcelik N, Izgi B, Temel A, Yildirim N, Okka M, Ozcan A, Yuksel N, Elgin U, Altan C, Ozer B. Prospective, non-interventional, multicenter study of the intraocular pressure-lowering effects of prostaglandin analog/prostamide-containing therapies in previously treated patients with open-angle glaucoma or ocular hypertension. Clin Ophthalmol. 2017 Apr 19;11:723-731. doi: 10.2147/OPTH.S119963. eCollection 2017.

    PMID: 28458511BACKGROUND

MeSH Terms

Conditions

Glaucoma, Open-AngleOcular Hypertension

Condition Hierarchy (Ancestors)

GlaucomaEye Diseases

Results Point of Contact

Title
Vice President Medical Affairs,
Organization
Allergan, Inc
clinicaltrials@allergan.com
714-246-4500

Study Officials

  • Medical Director

    Allergan

    STUDY DIRECTOR

Publication Agreements

PI is Sponsor Employee
No
Restriction Type
OTHER
Restrictive Agreement
Yes

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 26, 2012

First Posted

November 28, 2012

Study Start

March 7, 2013

Primary Completion

April 10, 2014

Study Completion

April 10, 2014

Last Updated

April 18, 2019

Results First Posted

April 27, 2015

Record last verified: 2019-04

Locations

TU(1)