Clinical trial NCT01448837: 24-Hour Intraocular Pressure Control With Bimatoprost/Timolol Versus Latanoprost as First Choice
Official title: 24-Hour Intraocular Pressure Control Obtained With the Bimatoprost/Timolol Fixed Combination Compared With Latanoprost as First Choice Therapy in Subjects With Exfoliation Syndrome, or Exfoliative Glaucoma
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Glaucoma
Lead sponsor: Aristotle University Of Thessaloniki
Sponsor class: OTHER
First posted: 2011-10-07
Enrollment: 37
Sex: ALL
Minimum age (years): 21
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

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.


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

Primary outcomes:
measure: 24-hour IOP reduction between the two medications
timeFrame: 3 months
Secondary outcomes:
Other outcomes:
Locations:
city: Thessaloniki
country: Greece
facility: Glaucoma Unit, 1st University Department of Ophthalmology
Study officials:
affiliation: Glaucoma Unit, 1st University Department of Ophthalmology
name: Anastasios G Konstas, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: