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

Aristotle University Of Thessaloniki

Status and phase: Completed; Phase 4

Conditions: Glaucoma

Treatments: Drug: Bimatoprost/Timolol, 24-hour intraocular pressure monitoring; Drug: Latanoprost, 24-hour intraocular pressure monitoring

Study type: Interventional

Funder types: Other

Identifiers

NCT01448837

A5134

Details and patient eligibility

About

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.

Enrollment: 37 patients

Sex: All

Ages: 21 to 80 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Single Blind

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37 participants in 2 patient groups

Bimatoprost/Timolol drops

Active Comparator group

Description:

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

Treatment:

Drug: Latanoprost, 24-hour intraocular pressure monitoring

Drug: Bimatoprost/Timolol, 24-hour intraocular pressure monitoring

Latanoprost drops

Active Comparator group

Description:

The patients will be crossed over to therapy with latanoprost

Treatment:

Drug: Latanoprost, 24-hour intraocular pressure monitoring

Drug: Bimatoprost/Timolol, 24-hour intraocular pressure monitoring