NCT01999348

Brief Summary

The study will evaluate patients diagnosed with POAG or OHT who are switched to GANFORT® UD (unit dose of fixed combination bimatoprost and timolol) therapy for medical reasons in accordance with physician standard clinical practice. All treatment decisions lie with the physician.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
1,553

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Nov 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

Study Start

First participant enrolled

November 25, 2013

Completed
1 day until next milestone

First Submitted

Initial submission to the registry

November 26, 2013

Completed
7 days until next milestone

First Posted

Study publicly available on registry

December 3, 2013

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 19, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 19, 2014

Completed
12 months until next milestone

Results Posted

Study results publicly available

December 9, 2015

Completed
Last Updated

April 19, 2019

Status Verified

April 1, 2019

Enrollment Period

1.1 years

First QC Date

November 26, 2013

Results QC Date

November 3, 2015

Last Update Submit

April 9, 2019

Conditions

Glaucoma, Primary Open AngleOcular Hypertension

Outcome Measures

Primary Outcomes (1)

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

    IOP is a measure of the fluid pressure inside the study eye. A result at the Final Visit that is lower than the result at Baseline indicates a reduction in IOP (improvement).

    Baseline, Final Visit (Week 8 to 12)

Secondary Outcomes (6)

  • Physician Assessment of IOP-Lowering Effect in the Study Eye Using a 3-Point Scale

    Baseline, Final Visit (Week 8 to 12)

  • Patient Assessment of Tolerability on a 4-Point Scale

    Final Visit (Week 8 to 12)

  • Physician Assessment of Tolerability on a 4-Point Scale

    Final Visit (Week 8 to 12)

  • Percentage of Patients Who Discontinued Treatment

    12 Weeks

  • Percentage of Patients Prescribed by the Physician to Continue Treatment

    Final Visit (Week 8 to 12)

  • +1 more secondary outcomes

Study Arms (1)

Patients with POAG or OHT

Patients with POAG or OHT treated with GANFORT® UD (fixed combination bimatoprost and timolol) administered in accordance with physician standard practice for up to 12 weeks.

Drug: Fixed Combination Bimatoprost and Timolol

Interventions

Fixed Combination Bimatoprost and TimololDRUG

Patients with POAG or OHT treated with GANFORT® UD (fixed combination bimatoprost and timolol) administered in accordance with physician standard practice for up to 12 weeks.

Also known as: GANFORT® UD
Patients with POAG or OHT

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients with primary open-angle glaucoma or ocular hypertension

You may qualify if:

  • Diagnosed with primary open-angle glaucoma or ocular hypertension
  • Previously prescribed intraocular pressure (IOP)-lowering medication with insufficient IOP control and is now being switched to GANFORT® UD for medical reasons

You may not qualify if:

  • None

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Unknown Facility

Wiesloch, Germany

Location

Related Publications (1)

  • Pfennigsdorf S, Eschstruth P, Hasemeyer S, Feuerhake C, Brief G, Grobeiu I, Shirlaw A. Preservative-free bimatoprost 0.03%/timolol 0.5% fixed combination in patients with glaucoma in clinical practice. Clin Ophthalmol. 2016 Sep 20;10:1837-1846. doi: 10.2147/OPTH.S106159. eCollection 2016.

    PMID: 27703324BACKGROUND

MeSH Terms

Conditions

Glaucoma, Open-AngleOcular Hypertension

Interventions

Timolol

Condition Hierarchy (Ancestors)

GlaucomaEye Diseases

Intervention Hierarchy (Ancestors)

PropanolaminesAmino AlcoholsAlcoholsOrganic ChemicalsPropanolsAminesThiadiazolesThiazolesSulfur CompoundsAzolesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsMorpholinesOxazines

Results Point of Contact

Title
Therapeutic Area Head,
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, 2013

First Posted

December 3, 2013

Study Start

November 25, 2013

Primary Completion

December 19, 2014

Study Completion

December 19, 2014

Last Updated

April 19, 2019

Results First Posted

December 9, 2015

Record last verified: 2019-04

Locations

DE(1)