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

NCT00759239 | Completed Phase 4

• 1 other identifier: EMD-06-02
• Study Type: interventional
• Target: 36
• Locations: 1 country
• Sites: 1

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.

Conditions

Open-angle Glaucoma; Ocular Hypertension

Keywords

Open-angle glaucoma (with or without pseudoexfoliation or pigment dispersion component), or ocular hypertension

Outcome Measures

Primary Outcomes (1)

• Reduction in intraocular pressure

  week 4, week 12

Secondary Outcomes (1)

• Adverse events

  Week 4, week 12

Study Arms (2)

1

EXPERIMENTAL

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%

2

EXPERIMENTAL

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%

Interventions

Travoprost 0.004% / Timolol maleate 0.5% DRUG

Solution, morning dosing

1

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Alcon Research: lead

Study Sites (1)

Western Eye Hospital

London, NW1 5YE, United Kingdom

Location

Related Links

• Results on European Database

MeSH Terms

Conditions

Glaucoma, Open-Angle; Ocular Hypertension

Interventions

Travoprost

Condition Hierarchy (Ancestors)

Glaucoma; Eye Diseases

Intervention Hierarchy (Ancestors)

Cloprostenol; Prostaglandins F, Synthetic; Prostaglandins, Synthetic; Prostaglandins; Eicosanoids; Fatty Acids, Unsaturated; Fatty Acids; Lipids; Autacoids; Inflammation Mediators; Biological Factors

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 24, 2008
• First Posted: September 25, 2008
• Study Start: September 1, 2008
• Primary Completion: January 1, 2011
• Study Completion: January 1, 2011
• Last Updated: November 22, 2016

Record last verified: 2012-01

Locations

GB (1)