NCT00887029

Brief Summary

Hypothesis:

  • H1: Efficacy of Duotrav will be superior to Xalacom at 24 hours post dosing when both medications are given in the morning
  • H2: A significant proportion of patients will prefer dosing of once daily topical fixed combination therapy in the morning compared to evening dosing

Trial Health

87
On Track

Trial Health Score

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

Enrollment
54

participants targeted

Target at P25-P50 for phase_4

Timeline
Completed

Started Jan 2009

Shorter than P25 for phase_4

Geographic Reach
1 country

2 active sites

Status
completed

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2009

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

April 21, 2009

Completed
2 days until next milestone

First Posted

Study publicly available on registry

April 23, 2009

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2009

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2009

Completed
Last Updated

April 21, 2015

Status Verified

April 1, 2015

Enrollment Period

10 months

First QC Date

April 21, 2009

Last Update Submit

April 20, 2015

Conditions

Open-Angle GlaucomaOcular Hypertension

Keywords

Topical prostaglandin analogueglaucomaPOAGOHTOAGocular hypertensionfixed combination protaglandin analogue therapyDuoTravtimololtravoprost24 hour post doseIOPdosing preference

Outcome Measures

Primary Outcomes (1)

  • IOP lowering efficacy of DuoTrav and Xalacom

    12 weeks

Secondary Outcomes (1)

  • To compare patient dosing preferences in terms of convenience and perceived compliance

    12 weeks

Study Arms (2)

DuoTrav

ACTIVE COMPARATOR
Drug: DuoTrav (travoprost-timolol ophthalmic drops)

Xalacom

ACTIVE COMPARATOR
Drug: Xalacom (latanoprost-timolol ophthalmic drops)

Interventions

DuoTrav (travoprost-timolol ophthalmic drops)DRUG

topical ophthalmic drops instilled 1 drop daily

Also known as: DuoTrav
DuoTrav
Xalacom (latanoprost-timolol ophthalmic drops)DRUG

topical ophthalmic drops instilled 1 drop daily

Also known as: Xalacom
Xalacom

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patients ≥ 18 years old, diagnosed with primary open angle glaucoma or ocular hypertension
  • IOP currently uncontrolled on beta blocker monotherapy, as judged by the investigator
  • Response to Timolol 0.5% was a ≥10% reduction in IOP
  • IOP at 9:00 of ≥ 20 mmHg while still on beta blocker

You may not qualify if:

  • Patients wearing contact lenses will be permitted to participate in the study provided that the contact lenses are removed during instillation of study medication and that the patient waits fifteen (15) minutes following drug instillation to re-insert the lenses. Contact lenses cannot be worn on study days.
  • Best corrected visual acuity worse than 0.6 logMAR or 20/80 Snellen in either eye.
  • Patients in whom the mean IOP in either eye at the screening exam visit is greater than 36 mmHg
  • History of ocular trauma within the past six (6) months.
  • History of ocular infection or ocular inflammation within the past three (3) months.
  • History of chronic or recurrent severe inflammatory eye disease (i.e., scleritis, uveitis)
  • History of severe or serious hypersensitivity to any components of the study medications.
  • Any abnormality preventing reliable applanation tonometry of either eye.
  • Intraocular surgery within the past six (6) months as determined by patient history and/or examination.
  • Patients with cup/disc ratio greater than 0.80 in either eye.
  • Patients with severe central visual field loss in either eye defined as a sensitivity 10 dB in at least two (2) of the four (4) visual field test points closest to the point of fixation.
  • History of severe retinal disease such as retinal degeneration, diabetic retinopathy or retinal detachment.
  • Current use of ANY glucocorticoid administered by any route. Patient must have washed out of the glucocorticoid for at least 4 weeks prior to study entry.
  • Use of any systemic prostaglandin or prostaglandin analogue (e.g., CYTOTEC) within the last three months.
  • Current use of topical non-steroidal anti inflammatory agents which inhibit cyclo-oxygenase and prostaglandin analogue synthesis.
  • +5 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Ophthalmic Consultant Centres

Mississauga, Ontario, L4W1W9, Canada

Location

Dr David B. Yan, M.D., F.R.C.S.C.

Toronto, Ontario, M5R2M8, Canada

Location

Related Publications (6)

  • Netland PA, Landry T, Sullivan EK, Andrew R, Silver L, Weiner A, Mallick S, Dickerson J, Bergamini MV, Robertson SM, Davis AA; Travoprost Study Group. Travoprost compared with latanoprost and timolol in patients with open-angle glaucoma or ocular hypertension. Am J Ophthalmol. 2001 Oct;132(4):472-84. doi: 10.1016/s0002-9394(01)01177-1.

    PMID: 11589866RESULT

  • Dubiner HB, Sircy MD, Landry T, Bergamini MV, Silver LH, Darell Turner F, Robertson S, Andrew RM, Weiner A, Przydryga J. Comparison of the diurnal ocular hypotensive efficacy of travoprost and latanoprost over a 44-hour period in patients with elevated intraocular pressure. Clin Ther. 2004 Jan;26(1):84-91. doi: 10.1016/s0149-2918(04)90008-2.

    PMID: 14996520RESULT

  • Topouzis F, Melamed S, Danesh-Meyer H, Wells AP, Kozobolis V, Wieland H, Andrew R, Wells D. A 1-year study to compare the efficacy and safety of once-daily travoprost 0.004%/timolol 0.5% to once-daily latanoprost 0.005%/timolol 0.5% in patients with open-angle glaucoma or ocular hypertension. Eur J Ophthalmol. 2007 Mar-Apr;17(2):183-90. doi: 10.1177/112067210701700206.

    PMID: 17415690RESULT

  • Diestelhorst M, Larsson LI; European Latanoprost Fixed Combination Study Group. A 12 week study comparing the fixed combination of latanoprost and timolol with the concomitant use of the individual components in patients with open angle glaucoma and ocular hypertension. Br J Ophthalmol. 2004 Feb;88(2):199-203. doi: 10.1136/bjo.2003.018234.

    PMID: 14736774RESULT

  • Yan DB, Battista RA, Haidich AB, Konstas AG. Comparison of morning versus evening dosing and 24-h post-dose efficacy of travoprost compared with latanoprost in patients with open-angle glaucoma. Curr Med Res Opin. 2008 Nov;24(11):3023-7. doi: 10.1185/03007990802426813. Epub 2008 Oct 14.

    PMID: 18826749RESULT

  • Alm A, Stjernschantz J. Effects on intraocular pressure and side effects of 0.005% latanoprost applied once daily, evening or morning. A comparison with timolol. Scandinavian Latanoprost Study Group. Ophthalmology. 1995 Dec;102(12):1743-52. doi: 10.1016/s0161-6420(95)30798-1.

    PMID: 9098273RESULT

MeSH Terms

Conditions

Glaucoma, Open-AngleOcular HypertensionGlaucoma

Interventions

DuotravXalacom

Condition Hierarchy (Ancestors)

Eye Diseases

Study Officials

  • David B Yan, MD

    Ophthalmic Consultant Centres

    PRINCIPAL INVESTIGATOR

  • Navroop Gill, OD

    Ophthalmic Consultant Centres

    STUDY CHAIR

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
SPONSOR

Study Record Dates

First Submitted

April 21, 2009

First Posted

April 23, 2009

Study Start

January 1, 2009

Primary Completion

November 1, 2009

Study Completion

November 1, 2009

Last Updated

April 21, 2015

Record last verified: 2015-04

Locations

CA(2)