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

Primary Purpose

Glaucoma

Status
Completed
Phase
Phase 4
Locations
Greece
Study Type
Interventional
Intervention
Bimatoprost/Timolol, 24-hour intraocular pressure monitoring
Latanoprost, 24-hour intraocular pressure monitoring
Sponsored by
Aristotle University Of Thessaloniki
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Glaucoma

Eligibility Criteria

21 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • Glaucoma Unit, 1st University Department of Ophthalmology

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

Bimatoprost/Timolol drops

Latanoprost drops

Arm Description

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

The patients will be crossed over to therapy with latanoprost

Outcomes

Primary Outcome Measures

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).

Secondary Outcome Measures

Full Information

First Posted
September 26, 2011
Last Updated
May 9, 2014
Sponsor
Aristotle University Of Thessaloniki
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1. Study Identification

Unique Protocol Identification Number
NCT01448837
Brief Title
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

2. Study Status

Record Verification Date
May 2014
Overall Recruitment Status
Completed
Study Start Date
April 2010 (undefined)
Primary Completion Date
March 2011 (Actual)
Study Completion Date
March 2011 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Aristotle University Of Thessaloniki

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Glaucoma

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Crossover Assignment
Masking
Investigator
Allocation
Randomized
Enrollment
37 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Bimatoprost/Timolol drops
Arm Type
Active Comparator
Arm Description
The patients will be treated with bimatoprost/timolol fixed combination therapy
Arm Title
Latanoprost drops
Arm Type
Active Comparator
Arm Description
The patients will be crossed over to therapy with latanoprost
Intervention Type
Drug
Intervention Name(s)
Bimatoprost/Timolol, 24-hour intraocular pressure monitoring
Other Intervention Name(s)
Ganfort, Xalatan
Intervention Description
Administered once in the evening
Intervention Type
Drug
Intervention Name(s)
Latanoprost, 24-hour intraocular pressure monitoring
Other Intervention Name(s)
Ganfort, Xalatan
Intervention Description
assessment of 24-hour efficacy for the two drugs after 3 months of chronic dosing
Primary Outcome Measure Information:
Title
24-hour IOP reduction between the two medications
Description
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).
Time Frame
3 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
21 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Anastasios G Konstas, MD, PhD
Organizational Affiliation
Glaucoma Unit, 1st University Department of Ophthalmology
Official's Role
Principal Investigator
Facility Information:
Facility Name
Glaucoma Unit, 1st University Department of Ophthalmology
City
Thessaloniki
Country
Greece

12. IPD Sharing Statement

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

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