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

• Status: Completed
• Trial end date: 2011-03-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Aristotle University Of Thessaloniki
• Treatments: Bimatoprost; Cloprostenol; Latanoprost; Timolol

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