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

Sponsor
Aristotle University Of Thessaloniki (Other)
Overall Status
Completed
CT.gov ID
NCT01448837
Collaborator
(none)
37
Enrollment
1
Location
2
Arms
11
Duration (Months)
3.4
Patients Per Site Per Month

Study Details

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.

Condition or Disease Intervention/Treatment Phase
  • Drug: Bimatoprost/Timolol, 24-hour intraocular pressure monitoring
  • Drug: Latanoprost, 24-hour intraocular pressure monitoring
 Phase 4

Study Design

Study Type:
Interventional
Actual Enrollment :
37 participants
Allocation:
Randomized
Intervention Model:
Crossover Assignment
Masking:
Single (Investigator)
Primary Purpose:
Treatment
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 Start Date :
Apr 1, 2010
Actual Primary Completion Date :
Mar 1, 2011
Actual Study Completion Date :
Mar 1, 2011

Arms and Interventions

Arm Intervention/Treatment
Active Comparator: Bimatoprost/Timolol drops

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

Drug: Bimatoprost/Timolol, 24-hour intraocular pressure monitoring
Administered once in the evening
Other Names:
  • Ganfort
  • Xalatan

    • Drug: Latanoprost, 24-hour intraocular pressure monitoring
    assessment of 24-hour efficacy for the two drugs after 3 months of chronic dosing
    Other Names:
  • Ganfort
  • Xalatan

    		•
    Active Comparator: Latanoprost drops

    The patients will be crossed over to therapy with latanoprost

    Drug: Bimatoprost/Timolol, 24-hour intraocular pressure monitoring
    Administered once in the evening
    Other Names:
  • Ganfort
  • Xalatan

    • Drug: Latanoprost, 24-hour intraocular pressure monitoring
    assessment of 24-hour efficacy for the two drugs after 3 months of chronic dosing
    Other Names:
  • Ganfort
  • Xalatan

    		•

    Outcome Measures

    Primary Outcome Measures

    1. 24-hour IOP reduction between the two medications [3 months]

      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).

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    21 Years to 80 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Glaucoma Unit, 1st University Department of Ophthalmology Thessaloniki Greece

    Sponsors and Collaborators

    • Aristotle University Of Thessaloniki

    Investigators

    • Principal Investigator: Anastasios G Konstas, MD, PhD, Glaucoma Unit, 1st University Department of Ophthalmology

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    AGP Konstas, Professor in Ophthalmology, Aristotle University Of Thessaloniki
    ClinicalTrials.gov Identifier:
    NCT01448837
    Other Study ID Numbers:
    • A5134
    First Posted:
    Oct 7, 2011
    Last Update Posted:
    May 12, 2014
    Last Verified:
    May 1, 2014
    Additional relevant MeSH terms:
    Glaucoma
    Timolol
    Bimatoprost
    Latanoprost
    Cloprostenol

    Study Results

    No Results Posted as of May 12, 2014