24-Hour Intraocular Pressure Control With Bimatoprost/Timolol Versus Latanoprost as First Choice

Phase 4

Completed

• Conditions: Glaucoma
• Interventions: Drug: Bimatoprost/Timolol, 24-hour intraocular pressure monitoring; Drug: Latanoprost, 24-hour intraocular pressure monitoring

• Registration Number: NCT01448837
• Lead Sponsor: Aristotle University Of Thessaloniki

Brief Summary

The primary objective of this crossover 24-hour Intraocular Pressure (IOP) trial is to compare the control obtained after 3 months of therapy with the bimatoprost/timolol fixed combination (BTFC, Ganfort) given once in the evening (20:00) versus latanoprost (Xalatan) administered once in the evening (20:00) in newly-diagnosed patients with exfoliation syndrome (XFS) and ocular hypertension, or exfoliative glaucoma (XFG) previously untreated and IOP greater than 29 mm Hg.

Detailed Description

Not available

Study Timeline

• Study Start: 2010-04
• Primary Completion: 2011-03
• Study Completion: 2011-03
• Study First Submitted: 2011-09-26
• Study First Submitted QC: 2011-10-06
• Study First Posted: 2011-10-07
• Status Verified: 2014-05
• Last Update Submitted: 2014-05-09
• Last Update Posted: 2014-05-12

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 37

Inclusion Criteria

• Patient has exfoliation syndrome with ocular hypertension, or exfoliative glaucoma and is older than 29 years
• Patient is newly diagnosed, or currently untreated and exhibits untreated morning IOP (2 separate IOP readings at 10:00)greater than 29 mm Hg in the study eye
• Study patients should have mild to moderate exfoliative glaucoma (VF loss <12 dB; cupping 0.8 or less)
• Patient with exfoliation syndrome should fulfill the IOP criterion (IOP > 29 mm Hg at 10:00)
• Patient deemed by investigator to require significant IOP reduction to obtain desired target IOP
• Patient agrees to be treated for at least 3 months with latanoprost and bimatoprost/timolol fixed combination drops dosed in the evening
• In study eye distance best corrected Snelen visual acuity greater than 1/10

Exclusion Criteria

• Contraindications to therapy with latanoprost, bimatoprost, or β-blockers
• History of non-adherence or previously recorded evidence of lack of response (<10% morning IOP reduction) to any antiglaucoma medication
• Patient can not understand the instructions and adhere to medications
• Patient is a female of childbearing potential or lactating mother
• Past history of trauma, inflammation, surgery, past use of steroids (within 2 months), severe dry eyes and use of contact lenses
• Signs of ocular infection, except blepharitis, or corneal abnormality that may affect IOP measurements
• The other eye can not receive the same therapy, or remain without medical therapy
• Closed angles

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Latanoprost drops	Bimatoprost/Timolol, 24-hour intraocular pressure monitoring	The patients will be crossed over to therapy with latanoprost
Latanoprost drops	Latanoprost, 24-hour intraocular pressure monitoring	The patients will be crossed over to therapy with latanoprost
Bimatoprost/Timolol drops	Latanoprost, 24-hour intraocular pressure monitoring	The patients will be treated with bimatoprost/timolol fixed combination therapy
Bimatoprost/Timolol drops	Bimatoprost/Timolol, 24-hour intraocular pressure monitoring	The patients will be treated with bimatoprost/timolol fixed combination therapy

Primary Outcome Measures

Name	Time	Method
24-hour IOP reduction between the two medications	3 months	Bimatoprost/Timolol will obtain a statistically greater 24-hour IOP reduction than latanoprost and the mean 24-hour IOP difference between the two medications will be clinically meaningful (at least 2 mm Hg).

Trial Locations

Locations (1)

Glaucoma Unit, 1st University Department of Ophthalmology; 🇬🇷 Thessaloniki, Greece