Intraocular Pressure Reduction With the Bimatoprost/Timolol Fixed Combination

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.

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Key information

Conditions

Glaucoma Eye Diseases Ocular Hypertension

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

University Eye Clinic

Larissa, Thessaly, 41110, Greece

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

Primary open angle glaucoma
Exfoliation glaucoma
Ocular hypertension

Exclusion criteria

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)

Treatment and study plan

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.

Other names: Lumigan, Ganfort

Primary outcomes

Mean diurnal intraocular pressure

Time frame: Five weeks on each medication

Sponsors and collaborators

Lead sponsor

Larissa University Hospital

Other

Registry information

Official study title

Efficacy Of The Bimatoprost/Timolol Fixed Combination In Patients Treated With Bimatoprost for Primary Open Angle Glaucoma, Exfoliation Glaucoma or Ocular Hypertension.

Important dates

Study start: 2009
Primary completion: 2010
Study completion: 2010
First posted: Jul 17, 2009
Registry last updated: Nov 30, 2010

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed