NCT00330577

Brief Summary

The purpose of this study is to compare the short-term mean 24-hour intraocular pressure control, 24-hour blood pressure effect and safety of Latanoprost/Timolol fixed combination given once in the evening with placebo once in the morning versus timolol maleate 0.5% given twice daily in patients with ocular hypertension and primary open-angle glaucoma.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
30

participants targeted

Target at below P25 for phase_4

Timeline
Completed

Started Apr 2006

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

April 1, 2006

Completed
2 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
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2007

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2007

Completed
Last Updated

May 12, 2014

Status Verified

May 1, 2014

Enrollment Period

1 year

First QC Date

May 26, 2006

Last Update Submit

May 9, 2014

Conditions

Primary Open Angle GlaucomaOcular Hypertension

Interventions

timolol maleate 0.5%DRUG
latanoprost/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
  • OHT

You may not qualify if:

  • Advanced glaucoma
  • Arterial Hypertension

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-AngleOcular Hypertension

Interventions

LatanoprostLubricant Eye Drops

Condition Hierarchy (Ancestors)

GlaucomaEye Diseases

Intervention Hierarchy (Ancestors)

Prostaglandins 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 4
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

April 1, 2006

Primary Completion

April 1, 2007

Study Completion

July 1, 2007

Last Updated

May 12, 2014

Record last verified: 2014-05

Locations

GR(1)