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

Ophthalmic Consultants Centres, Canada

Status and phase

Completed

Phase 4

Conditions

Open-Angle Glaucoma

Ocular Hypertension

Treatments

Drug: DuoTrav (travoprost-timolol ophthalmic drops)

Drug: Xalacom (latanoprost-timolol ophthalmic drops)

Study type

Interventional

Funder types

Other

Industry

Identifiers

NCT00887029

OCC1023

Details and patient eligibility

About

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

Full description

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.

Enrollment

54 patients

Sex

All

Ages

18+ years old

Volunteers

Accepts Healthy Volunteers

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
Non-prescription and prescription topical ophthalmic products and systemic medications other than those mentioned in the exclusion criteria will be allowed during the study.
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.

Exclusion criteria

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.