NCT00941096

Brief Summary

The purpose of this study is to examine the ocular hypotensive effect of Bimatoprost and the potential additional effect of the Bimatoprost/Timolol fixed combination in eyes with ocular hypertension, primary open angle glaucoma or exfoliation 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 Jul 2009

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

July 1, 2009

Completed
15 days until next milestone

First Submitted

Initial submission to the registry

July 16, 2009

Completed
1 day until next milestone

First Posted

Study publicly available on registry

July 17, 2009

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2010

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2010

Completed
Last Updated

November 30, 2010

Status Verified

November 1, 2010

Enrollment Period

1.3 years

First QC Date

July 16, 2009

Last Update Submit

November 29, 2010

Conditions

GlaucomaOcular Hypertension

Keywords

GlaucomaOcular HypertensionLumiganGanfort

Outcome Measures

Primary Outcomes (1)

  • Mean diurnal intraocular pressure

    Five weeks on each medication

Interventions

Bimatoprost and Bimatoprost/Timolol fixed combination.DRUG

Following an appropriate wash-out period, participants were given a 5-week long treatment with Bimatoprost 0.03% once daily in the evening followed by a further 5-week long treatment with the Bimatoprost 0.03%/Timolol 0.5% fixed combination administered in the evening.

Also known as: Lumigan, Ganfort

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Primary open angle glaucoma
  • Exfoliation glaucoma
  • Ocular hypertension

You may not qualify if:

  • Younger than 18 years old
  • Inability to understand and/or follow study requirements
  • Women of childbearing potential not using reliable birth control, pregnant or lactating women
  • History of chronic obstructive pulmonary disease, heart failure, 2nd or 3rd AV block
  • Anticipated modification of treatment for systemic hypertension during the study period
  • History of ocular herpes, corneal scarring, conventional or laser surgery or macular pathology
  • History of allergy, poor tolerability or poor response to study medication
  • Best corrected visual acuity less than 0.4
  • Significant visual field defect (MD\<15.0 dB)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University Eye Clinic

Larissa, Thessaly, 41110, Greece

Location

MeSH Terms

Conditions

GlaucomaOcular Hypertension

Interventions

BimatoprostGanfort

Condition Hierarchy (Ancestors)

Eye Diseases

Intervention Hierarchy (Ancestors)

AmidesOrganic ChemicalsCloprostenolProstaglandins F, SyntheticProstaglandins, SyntheticProstaglandinsEicosanoidsFatty Acids, UnsaturatedFatty AcidsLipidsAutacoidsInflammation MediatorsBiological Factors

Study Design

Study Type
interventional
Phase
phase 4
Allocation
NA
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER

Study Record Dates

First Submitted

July 16, 2009

First Posted

July 17, 2009

Study Start

July 1, 2009

Primary Completion

November 1, 2010

Study Completion

November 1, 2010

Last Updated

November 30, 2010

Record last verified: 2010-11

Locations

GR(1)