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

NCT ID: NCT01448837

Last Updated: 2014-05-12

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 37 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2010-04-30
• Study Completion Date: 2011-03-31

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.

Conditions

Glaucoma

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Bimatoprost/Timolol drops

The patients will be treated with bimatoprost/timolol fixed combination therapy

Group Type: ACTIVE_COMPARATOR

Bimatoprost/Timolol, 24-hour intraocular pressure monitoring

Intervention Type: DRUG

Administered once in the evening

Latanoprost, 24-hour intraocular pressure monitoring

Intervention Type: DRUG

assessment of 24-hour efficacy for the two drugs after 3 months of chronic dosing

Latanoprost drops

The patients will be crossed over to therapy with latanoprost

Group Type: ACTIVE_COMPARATOR

Bimatoprost/Timolol, 24-hour intraocular pressure monitoring

Intervention Type: DRUG

Administered once in the evening

Latanoprost, 24-hour intraocular pressure monitoring

Intervention Type: DRUG

assessment of 24-hour efficacy for the two drugs after 3 months of chronic dosing

Interventions

Bimatoprost/Timolol, 24-hour intraocular pressure monitoring

Administered once in the evening

Intervention Type: DRUG

Latanoprost, 24-hour intraocular pressure monitoring

assessment of 24-hour efficacy for the two drugs after 3 months of chronic dosing

Intervention Type: DRUG

Other Intervention Names

Ganfort; Xalatan; Ganfort; Xalatan

Eligibility Criteria

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

• Minimum Eligible Age: 21 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Aristotle University Of Thessaloniki

OTHER

Sponsor Role: lead

Responsible Party

AGP Konstas

Professor in Ophthalmology

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Anastasios G Konstas, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Glaucoma Unit, 1st University Department of Ophthalmology

Locations

Glaucoma Unit, 1st University Department of Ophthalmology

Thessaloniki, , Greece

Countries

Greece

Other Identifiers

A5134

Identifier Type: -

Identifier Source: org_study_id