24-Hour Intraocular Pressure (IOP) And Blood Pressure Control In Glaucoma And Ocular Hypertension Patients

• Sponsor: Aristotle University Of Thessaloniki (Other)
• Overall Status: Completed
• CT.gov ID: NCT00330577
• Collaborator: (none)
• Enrollment: 30
• Location: 1
• Duration (Months): 15
• Patients Per Site Per Month: 2

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Primary Open Angle Glaucoma; Ocular Hypertension	Drug: timolol maleate 0.5%; Drug: latanoprost/timolol fixed combination; Drug: placebo (artificial tears)	Phase 4

Study Design

• Study Type: Interventional
• Allocation: Randomized
• Intervention Model: Crossover Assignment
• Masking: Double
• Primary Purpose: Treatment
• Official Title: 24-Hour Intraocular Pressure (IOP) And Blood Pressure Control In Glaucoma And Ocular Hypertension Patients
• Study Start Date: Apr 1, 2006
• Actual Primary Completion Date: Apr 1, 2007
• Actual Study Completion Date: Jul 1, 2007

Outcome Measures

Primary Outcome Measures

Eligibility Criteria

Criteria

• Ages Eligible for Study: 29 Years to 80 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• POAG

• OHT

Exclusion Criteria:

• Advanced glaucoma

• Arterial Hypertension

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Glaucoma Unit, A University Dept of Ophthalmology, AHEPA Hospital	Thessaloniki		Greece	546 36

Sponsors and Collaborators

• Aristotle University Of Thessaloniki

Investigators

• Principal Investigator: AGP Konstas, MD, PhD, Glaucoma Unit, A University Dept of Ophthalmology, AHEPA Hospital

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: AGP Konstas, Professor in Ophthalmology, Aristotle University Of Thessaloniki
• ClinicalTrials.gov Identifier: NCT00330577
• Other Study ID Numbers: A594
• First Posted: May 29, 2006
• Last Update Posted: May 12, 2014
• Last Verified: May 1, 2014

• Additional relevant MeSH terms: Glaucoma; Glaucoma, Open-Angle; Ocular Hypertension; Hypertension; Timolol; Latanoprost; Lubricant Eye Drops

Study Results

No Results Posted as of May 12, 2014