NCT00331240

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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
32

participants targeted

Target at below P25 for phase_3

Timeline
Completed

Started Mar 2006

Shorter than P25 for phase_3

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

March 1, 2006

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

May 26, 2006

Completed
3 days until next milestone

First Posted

Study publicly available on registry

May 29, 2006

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2007

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2007

Completed
Last Updated

May 12, 2014

Status Verified

May 1, 2014

Enrollment Period

10 months

First QC Date

May 26, 2006

Last Update Submit

May 9, 2014

Conditions

Primary Open Angle GlaucomaExfoliation Syndrome

Interventions

travoprost/timolol fixed combinationDRUG
placebo (artificial tears)DRUG

Eligibility Criteria

Age29 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • POAG
  • Exfoliation syndrome

You may not qualify if:

  • Advanced glaucoma

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Glaucoma Unit, A University Dept of Ophthalmology, AHEPA Hospital

Thessaloniki, 546 36, Greece

Location

MeSH Terms

Conditions

Glaucoma, Open-AngleExfoliation Syndrome

Interventions

TravoprostLubricant Eye Drops

Condition Hierarchy (Ancestors)

GlaucomaOcular HypertensionEye DiseasesIris DiseasesUveal Diseases

Intervention Hierarchy (Ancestors)

CloprostenolProstaglandins F, SyntheticProstaglandins, SyntheticProstaglandinsEicosanoidsFatty Acids, UnsaturatedFatty AcidsLipidsAutacoidsInflammation MediatorsBiological FactorsOphthalmic SolutionsPharmaceutical SolutionsSolutionsPharmaceutical PreparationsTherapeutic UsesPharmacologic ActionsChemical Actions and UsesLubricantsSpecialty Uses of Chemicals

Study Officials

  • AGP Konstas, MD, PhD

    Glaucoma Unit, A University Dept of Ophthalmology, AHEPA Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
DOUBLE
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor in Ophthalmology

Study Record Dates

First Submitted

May 26, 2006

First Posted

May 29, 2006

Study Start

March 1, 2006

Primary Completion

January 1, 2007

Study Completion

February 1, 2007

Last Updated

May 12, 2014

Record last verified: 2014-05

Locations

GR(1)