A 12 Week Comparison of DuoTrav and Xalacom in Open-Angle Glaucoma

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

54 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-01-31

Study Completion Date

2009-11-30

Brief Summary

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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

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Detailed Description

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* Primary objective: Compare IOP-lowering efficacy of morning dosing of Duotrav to Xalacom.
* Secondary objective: Compare patient dosing preferences for topical prostaglandin therapy in terms of convenience and perceived compliance.

Conditions

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Open-Angle Glaucoma Ocular Hypertension

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Investigators

Study Groups

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DuoTrav

Group Type ACTIVE_COMPARATOR

DuoTrav (travoprost-timolol ophthalmic drops)

Intervention Type DRUG

topical ophthalmic drops instilled 1 drop daily

Xalacom

Group Type ACTIVE_COMPARATOR

Xalacom (latanoprost-timolol ophthalmic drops)

Intervention Type DRUG

topical ophthalmic drops instilled 1 drop daily

Interventions

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DuoTrav (travoprost-timolol ophthalmic drops)

topical ophthalmic drops instilled 1 drop daily

Intervention Type DRUG

Xalacom (latanoprost-timolol ophthalmic drops)

topical ophthalmic drops instilled 1 drop daily

Intervention Type DRUG

Other Intervention Names

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DuoTrav Xalacom

Eligibility Criteria

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Inclusion Criteria

* 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

Exclusion Criteria

* 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.
* Any form of glaucoma other than open-angle glaucoma (with or without a pigment dispersion or pseudoexfoliation component).
* Current use of topical non-steroidal anti inflammatory agents which inhibit cyclo-oxygenase and prostaglandin analogue synthesis
* Angle grade less than 2 (extreme narrow angle with complete or partial closure) as measured by gonioscopy.
* Therapy with another investigational agent within the past 30 days
* Patients who would be at risk from treatment with a topical prostaglandin or prostaglandin analogue, are contraindicated for use of beta-blockers or any other medication used in this study, or who would be at risk from participation in the study.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes