24-Hour Intraocular Pressure (IOP) Control With Travopros... | NCT00331240

Studies
24-Hour Intraocular Pressure (IOP) Control With Travoprost/Timolol Fixed Combination

NCT00331240

Sponsor

Aristotle University Of Thessaloniki

Status

Completed

Last Update Posted

May 12, 2014Estimated

Enrollment

Phase

Phase 3

Conditions

Primary Open Angle Glaucoma
Exfoliation Syndrome

Interventions

travoprost/timolol fixed combination
placebo (artificial tears)

Countries

Greece

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

May 2014

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

Mar 2006

Primary Completion Date

Jan 2007Actual

Completion Date

Feb 2007Actual

First Submitted Date

May 26, 2006

First Submission Date that Met QC Criteria

May 26, 2006

First Posted Date

May 29, 2006Estimated

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

May 9, 2014

Last Update Posted Date

May 12, 2014Estimated

Sponsor/Collaborators Module

Responsible Party, by Official Title

AGP Konstas, Professor in Ophthalmology, Aristotle University Of ThessalonikiPrincipal Investigator

Lead Sponsor

Aristotle University Of ThessalonikiOTHER

Collaborators

Not provided

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

The purpose of this study is to compare the short-term (8 week) mean 24-hour intraocular pressure control and safety of TravTim fixed combination given once in the evening with placebo once in the morning versus TravTim given once in the morning with placebo once in the evening in patients with open-angle glaucoma.

Detailed Description

Not provided

Design Module

Study Type

Interventional

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

Phase 3

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

POAG
Exfoliation syndrome

Exclusion Criteria:

Advanced glaucoma

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

29 Years

Maximum Age

80 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
AGP Konstas, MD, PhD	Glaucoma Unit, A University Dept of Ophthalmology, AHEPA Hospital	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Glaucoma Unit, A University Dept of Ophthalmology, AHEPA Hospital		Thessaloniki		546 36	Greece

Condition Browse Module

MeSH Terms

ID	Term
D005902	Glaucoma, Open-Angle
D017889	Exfoliation Syndrome

Ancestor Terms

ID	Term
D005901	Glaucoma
D009798	Ocular Hypertension
D005128	Eye Diseases
D007499	Iris Diseases

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D000069557	Travoprost
D065346	Lubricant Eye Drops

Ancestor Terms

ID	Term
D003008	Cloprostenol
D011461	Prostaglandins F, Synthetic
D011465	Prostaglandins, Synthetic
D011453	Prostaglandins

Browse Leaves

Not provided

Browse Branches

Not provided

Name	Type	Description	Arm Group Labels	Other Names
travoprost/timolol fixed combination	Drug
placebo (artificial tears)	Drug