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

Glaucoma Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01448837
• Other study ID #: A5134
• Status: Completed
• Phase: Phase 4
• First received: September 26, 2011
• Last updated: May 9, 2014
• Start date: April 2010
• Est. completion date: March 2011

Study information

• Verified date: May 2014
• Source: Aristotle University Of Thessaloniki
• Contact: n/a
• Is FDA regulated: No
• Health authority: Greece: National Organization of Medicines
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 37
• Est. completion date: March 2011
• Est. primary completion date: March 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 21 Years to 80 Years

Eligibility

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 ß-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

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Single Blind (Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Glaucoma

Intervention

Drug:
• Bimatoprost/Timolol, 24-hour intraocular pressure monitoring
Administered once in the evening
• Latanoprost, 24-hour intraocular pressure monitoring
assessment of 24-hour efficacy for the two drugs after 3 months of chronic dosing

Locations

Country	Name	City	State
Greece	Glaucoma Unit, 1st University Department of Ophthalmology	Thessaloniki

Sponsors (1)

Lead Sponsor	Collaborator
Aristotle University Of Thessaloniki

Country where clinical trial is conducted

Greece, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	24-hour IOP reduction between the two medications	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).	3 months	No