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

A 12 Week Comparison of DuoTrav and Xalacom at 24 Hours Post-Dose in the Treatment of Open-Angle Glaucoma (the DVX Study)

Status

Completed

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00887029

Acronym

DVX

Enrollment

Registered

2009-04-23

Start date

2009-01-31

Completion date

2009-11-30

Last updated

2015-04-21

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Ocular Hypertension, Open-Angle Glaucoma

Keywords

Topical prostaglandin analogue, glaucoma, POAG, OHT, OAG, ocular hypertension, fixed combination protaglandin analogue therapy, DuoTrav, timolol, travoprost, 24 hour post dose, IOP, dosing preference

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

Detailed 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.

Interventions

DRUGDuoTrav (travoprost-timolol ophthalmic drops)

topical ophthalmic drops instilled 1 drop daily

DRUGXalacom (latanoprost-timolol ophthalmic drops)

topical ophthalmic drops instilled 1 drop daily

Study design

Allocation

RANDOMIZED

Intervention model

CROSSOVER

Primary purpose

TREATMENT

Masking

SINGLE (Investigator)

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Yes

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.

Design outcomes

Primary

Measure	Time frame
IOP lowering efficacy of DuoTrav and Xalacom	12 weeks

Secondary

Measure	Time frame
To compare patient dosing preferences in terms of convenience and perceived compliance	12 weeks

Countries

Canada

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026