Non Interventional Study With Primary Open Angle Glaucoma... | NCT00801437

Status Module

Record Verification Date

Jun 2011

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Oct 2008

Primary Completion Date

Jun 2009Actual

Completion Date

Jun 2009Actual

First Submitted Date

Nov 19, 2008

First Submission Date that Met QC Criteria

Dec 2, 2008

First Posted Date

Dec 3, 2008Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Feb 17, 2021

Last Update Posted Date

Feb 18, 2021Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

This study is designed to evaluate the safety and tolerability of Xalacom in patients with primary glaucoma

Detailed Description

according to physicians decision, patients who met inclusion and exclusion criteria and sign the ICD

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

457Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Xalacom treatment		patients with primary glaucoma	Drug: Xalacom

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Xalacom	Drug	Xalacom 1 drop into the affected eye daily	Xalacom treatment

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Incidence of ocular hyperemia		12 months
safety of treatment		12 months

Secondary Outcomes

Measure	Description	Time Frame
effectiveness in IOP lowering		12 months

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

primary open angle glaucoma
ocular hypertension
age >18 years

Exclusion Criteria:

bradycardia
obstructive pulmonary disease
hypersensitivity to the drug

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

99 Years

Standard Ages

AdultOlder Adult

Study Population

Patients >18 years with primary open angle glaucoma or ocular hypertension

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Pfizer CT.gov Call Center	Pfizer	Study Director

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Pfizer Investigational Site		Banovce N. Bebravou		957 01	Slovakia
Pfizer Investigational Site

References Module

Citations

Not provided

ID	Term
D005902	Glaucoma, Open-Angle
D005901	Glaucoma

ID	Term
D009798	Ocular Hypertension
D005128	Eye Diseases