NCT01448837

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
37

participants targeted

Target at below P25 for phase_4

Timeline
Completed

Started Apr 2010

Shorter than P25 for phase_4

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2010

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2011

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2011

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

September 26, 2011

Completed
11 days until next milestone

First Posted

Study publicly available on registry

October 7, 2011

Completed
Last Updated

May 12, 2014

Status Verified

May 1, 2014

Enrollment Period

11 months

First QC Date

September 26, 2011

Last Update Submit

May 9, 2014

Conditions

Glaucoma

Outcome Measures

Primary Outcomes (1)

  • 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

Study Arms (2)

Bimatoprost/Timolol drops

ACTIVE COMPARATOR

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

Drug: Bimatoprost/Timolol, 24-hour intraocular pressure monitoringDrug: Latanoprost, 24-hour intraocular pressure monitoring

Latanoprost drops

ACTIVE COMPARATOR

The patients will be crossed over to therapy with latanoprost

Drug: Bimatoprost/Timolol, 24-hour intraocular pressure monitoringDrug: Latanoprost, 24-hour intraocular pressure monitoring

Interventions

Bimatoprost/Timolol, 24-hour intraocular pressure monitoringDRUG

Administered once in the evening

Also known as: Ganfort, Xalatan
Bimatoprost/Timolol dropsLatanoprost drops
Latanoprost, 24-hour intraocular pressure monitoringDRUG

assessment of 24-hour efficacy for the two drugs after 3 months of chronic dosing

Also known as: Ganfort, Xalatan
Bimatoprost/Timolol dropsLatanoprost drops

Eligibility Criteria

Age21 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Glaucoma Unit, 1st University Department of Ophthalmology

Thessaloniki, Greece

Location

MeSH Terms

Conditions

Glaucoma

Interventions

BimatoprostTimololGanfortLatanoprost

Condition Hierarchy (Ancestors)

Ocular HypertensionEye Diseases

Intervention Hierarchy (Ancestors)

AmidesOrganic ChemicalsCloprostenolProstaglandins F, SyntheticProstaglandins, SyntheticProstaglandinsEicosanoidsFatty Acids, UnsaturatedFatty AcidsLipidsAutacoidsInflammation MediatorsBiological FactorsPropanolaminesAmino AlcoholsAlcoholsPropanolsAminesThiadiazolesThiazolesSulfur CompoundsAzolesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsMorpholinesOxazines

Study Officials

  • Anastasios G Konstas, MD, PhD

    Glaucoma Unit, 1st University Department of Ophthalmology

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
INVESTIGATOR
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor in Ophthalmology

Study Record Dates

First Submitted

September 26, 2011

First Posted

October 7, 2011

Study Start

April 1, 2010

Primary Completion

March 1, 2011

Study Completion

March 1, 2011

Last Updated

May 12, 2014

Record last verified: 2014-05

Locations

GR(1)