Characteristics of the medicine
DuoTrav is an eye drop that comes in the form of a clear solution. DuoTrav contains two
active ingredients: travoprost (40 micrograms / ml) and timolol (5 mg / ml).
Therapeutic indications
DuoTrav is used to reduce intraocular pressure (the pressure inside the eye, in acronym IOP-IntraOcular Pressure). It is used in patients with open-angle glaucoma (a disease that causes the pressure inside the eye to increase due to the inability to drain the fluid) and in patients with ocular hypertension (ie with pressure inside the eye). of the eye above the norm). DuoTrav contains a combination of drugs, a beta-blocker (timolol) and a prostaglandin analogue (travoprost), and is used in patients who do not respond sufficiently to eye drops containing only beta-blockers or prostaglandin analogs only. DuoTrav can only be obtained with a prescription.
How to use
The dose to be used is one drop of DuoTrav in the affected eye or one affected eye
once a day, in the morning or in the evening. The eye drops should be applied at the same time each day. DuoTrav is not recommended for patients under 18 years of age.
Mechanisms of action
Raised IOP causes damage to the retina (the light-sensitive membrane at the back of the eye) and to the optic nerve that sends signals from the eye to the brain. This can cause severe vision loss and even blindness. By lowering the IOP, DuoTrav reduces the risk of eye damage. DuoTrav contains two active ingredients: travoprost and timolol. These two drugs lower the pressure in the eye by distinct mechanisms. Travoprost is a prostaglandin analogue that works by increasing the outflow of fluid from the eye. Travoprost alone has already obtained marketing approval in the European Union under the name TRAVATAN.
Timolol is a beta blocker that works by reducing the production of fluid within the eye. Timolol has been used in the treatment of glaucoma since the 1970s. The combined effect of the two substances produces a greater reduction in IOP than that determined by the two drugs used alone.
Studies carried out
Five clinical studies were conducted in 1,499 patients with increased IOP caused by open-angle glaucoma or ocular hypertension. These studies included patients aged 18 to 91 years (half of whom were elderly) and lasted from 6 weeks to 12 months. DuoTrav was studied by administering it at different times of the day (morning or evening), comparing it with each of the two individual components and giving the two components in the form of separate eye drops. The 12-month study compared DuoTrav with eye drops containing a combination of latanoprost (a prostaglandin analogue) and timolol. The average IOP at various times represented the main parameter for evaluating the efficacy (IOP is measured in mmHg; in a patient with glaucoma its value is generally greater than 21 mmHg).
Benefits found following the studies
DuoTrav reduced IOP in all studies: the mean reduction obtained was approximately 8-10 mmHg, plus or minus one third less than the pre-treatment value. DuoTrav was more effective in lowering IOP than timolol alone or TRAVATAN alone. DuoTrav was as effective as the two drugs given as separate eye drops and as effective as the eye drops containing both latanoprost and timolol.
Associated Risks
The most common side effect (seen in 15% of patients in clinical trials) is ocular hyperaemia (increased blood flow to the eye, which causes eye irritation and redness). For the complete list of side effects reported with the "use of DuoTrav, see package insert.
DuoTrav must not be used in people who may be hypersensitive (allergic) to travoprost, timolol (and other beta-blockers) or any of the other ingredients. DuoTrav must not be given to people with asthma or severe lung disease, or to people with heart problems. For a complete list of use restrictions, see the package insert.
DuoTrav contains benzalkonium chloride, a substance that can discolour soft contact lenses.
Therefore, some caution is required in people who wear soft contact lenses. DuoTrav can induce a change in the color of the iris (which tends to darken) and a thickening, darkening or lengthening of the eyelashes.
Reasons for approval
DuoTrav is a combination of travoprost and timolol in fixed doses that can improve IOP control. Its effectiveness is superior to the two components taken individually and equivalent to the two components administered together, but in the form of two distinct eye drops. The Committee for Medicinal Products for Human Use (CHMP) decided that DuoTrav's benefits are greater than its risks for the treatment of open-angle glaucoma or ocular hypertension in patients who do not respond sufficiently to beta-blockers or analogues. of prostaglandins for topical use. Therefore, the committee recommended that DuoTrav be granted the Marketing Authorization.
Further information
On April 24, 2006, the European Commission granted Alcon Laboratories (UK) Limited a "Marketing Authorization" for DuoTrav, valid throughout the European Union.
For the full evaluation version (EPAR) of DuoTrav, click here.
Last update of this summary: March 2006.
The information about DuoTrav - eye drops published on this page may be out of date or incomplete. For a correct use of this information, see the Disclaimer and useful information page.
