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Phase IV Randomised Double-masked Clinical Trial: Assessing Morning Versus Evening Dosing of a Fixed Dose Combination of Travoprost 0.004% / Timolol Maleate 0.5% in Patients With Primary Open-angle Glaucoma or Ocular Hypertension

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00759239
Recruitment Status : Completed
First Posted : September 25, 2008
Last Update Posted : November 22, 2016
Information provided by (Responsible Party):
Alcon Research

Brief Summary:
The purpose of this study is to assess the IOP-lowering efficacy of a combination of Travoprost / Timolol maleate, dosed in the morning or in the evening, in patients with open-angle glaucoma or ocular hypertension, who have an insufficiently controlled IOP (mmHg), and are using prostaglandin analogue monotherapy.

Condition or disease Intervention/treatment Phase
Open-angle Glaucoma Ocular Hypertension Drug: Travoprost 0.004% / Timolol maleate 0.5% Phase 4

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 36 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Study Start Date : September 2008
Actual Primary Completion Date : January 2011
Actual Study Completion Date : January 2011

Arm Intervention/treatment
Experimental: 1
One drop of Travoprost 0.004% / Timolol maleate 0.5% in each eye at 9 am and 1 drop of Timolol vehicle as placebo in each eye at 9 pm for 12 weeks.
Drug: Travoprost 0.004% / Timolol maleate 0.5%
Solution, morning dosing

Experimental: 2
One drop of Timolol vehicle as placebo in each eye at 9 am and one drop of Travoprost 0.004% / Timolol maleate 0.5% in each eye at 9 pm for 12 weeks.
Drug: Travoprost 0.004% / Timolol maleate 0.5%
Solution, evening dosing

Primary Outcome Measures :
  1. Reduction in intraocular pressure [ Time Frame: week 4, week 12 ]

Secondary Outcome Measures :
  1. Adverse events [ Time Frame: Week 4, week 12 ]

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No


  • Male or female adult patients over the age of 18 years
  • Current treatment with prostaglandin analogue monotherapy, IOP-lowering medication.
  • Meet the following IOP entry criteria in at least one treated eye (mean IOP):

    • ≥ 19 mmHg
    • ≤ 28 mmHg
  • The patient is willing and able to sign and date the Informed Consent Form. Patients who wear contact lenses will be able to participate in the study, provided that the contact lenses are removed before instillation of study medication, and that the patient agrees to wait a minimum of 15 minutes, before re-inserting the lenses.


  • Females of childbearing potential (i.e. - those who are not surgically sterilised at least three months prior to the study start, or are not at least one year post-menopausal), who are:

    • Currently pregnant
    • Have a positive result on a urine pregnancy test at the Eligibility Visit
    • Intend to become pregnant during the study period
    • Are breast-feeding
    • Are not using highly effective birth control measures, for example;
  • Hormonal - oral, implanted, or injected contraceptives or;
  • Mechanical - spermicide in conjunction with a barrier such a condom or diaphragm or;
  • Intra-Uterine Device (IUD)
  • Any form of glaucoma other than open-angle glaucoma (with or without a pigment dispersion or pseudo-exfoliation component).
  • Current or previous therapy with another investigational agent, within 30 days prior to study entry.
  • History of chronic or recurrent severe inflammatory eye disease (e.g., scleritis, uveitis, herpes keratitis), in either eye.
  • History of ocular trauma within the past six months in either eye
  • History of ocular infection or ocular inflammation within the past three months in either eye.
  • History of clinically significant or progressive retinal disease such as retinal degeneration, diabetic retinopathy, or retinal detachment in either eye.
  • History of any other severe ocular pathology (including severe dry eyes), in either eye that would preclude the administration of a topical prostaglandin analogue.
  • Intraocular surgery within the past six months as determined by patient history and/or examination in either eye.
  • Ocular laser surgery within the past three months as determined by patient history and/or examination in either eye.
  • Any abnormality preventing reliable applanation tonometry of either eye.
  • Angle grade less than Grade 2 in either eye, as measured by gonioscopy (extreme narrow angle with complete or partial closure), assessed within the previous 12 months.
  • Cup/disc ratio greater than 0.80 in either eye, assessed within the previous six months.
  • Severe central visual field loss in either eye, defined as a sensitivity of ≤ 10 bB in at least two of the four visual field test points, closest to the point of fixation, assessed within the previous six months.
  • Unable to safely discontinue all IOP lowering medication, for a minimum period of 28 days prior to Baseline Visit.
  • Unable to safely discontinue all glucocorticoid medications administered by any route. Before the Eligibility Visit, patients must have performed a Wash Out of at least four weeks for any intermittent glucocorticoid medications and must be able to remain off these medications for the duration of the study.
  • Use of any additional topical or systemic ocular hyposensitive medication during the study.
  • History of bronchial asthma, or severe chronic obstructive pulmonary disease that would preclude the safe administration of a topical beta-blocker.
  • Less than 30 days stable dosing regimen before the Screening Visit of any non-glaucoma medications or substances administered by any route and used on a chronic basis that may affect IOP. These may include, but are not limited to the following:

    • Sympathomimetic agents
    • Antimuscarinic agents
    • Antihistamines
    • Phenothiazines
    • Tricyclic antidepressants
    • Beta-antagonist blocking agents
    • Alpha agonists
    • Alpha-adrenergic blocking agents
    • Calcium channel blockers
    • Angiotensin converting enzyme inhibitors
    • Cardiac gylcosides
  • History or other evidence of severe illness or any other conditions which would make the patient, in the opinion of the investigator, unsuitable for the study.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00759239

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United Kingdom
Western Eye Hospital
London, United Kingdom, NW1 5YE
Sponsors and Collaborators
Alcon Research
Additional Information:
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Responsible Party: Alcon Research Identifier: NCT00759239    
Other Study ID Numbers: EMD-06-02
First Posted: September 25, 2008    Key Record Dates
Last Update Posted: November 22, 2016
Last Verified: January 2012
Keywords provided by Alcon Research:
Open-angle glaucoma (with or without pseudoexfoliation or pigment dispersion component), or ocular hypertension
Additional relevant MeSH terms:
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Glaucoma, Open-Angle
Ocular Hypertension
Vascular Diseases
Cardiovascular Diseases
Eye Diseases
Maleic acid
Adrenergic beta-Antagonists
Adrenergic Antagonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Anti-Arrhythmia Agents
Antihypertensive Agents
Enzyme Inhibitors