24-hour Intraocular Pressure (IOP) Control With the Bimatoprost/Timolol Fixed Combination (BTFC)

Aristotle University Of Thessaloniki

Status and phase

Completed

Phase 4

Conditions

Glaucoma

Treatments

Drug: Drug: bimatoprost/timolol fixed combination AM

Drug: Bimatoprost/timolol fixed combination dosed PM

Study type

Interventional

Funder types

Other

Identifiers

NCT00486486

A3241

Details and patient eligibility

About

The objective of this crossover, randomized, placebo controlled, double-masked study is to compare the short-term (12 weeks) mean 24-hour IOP control and safety of the new fixed combination (bimatoprost/timolol, BTFC) given PM with placebo once in the morning, versus BTFC given AM with placebo once in the evening versus bimatoprost given in the evening in patients with exfoliative glaucoma (XFG).

Full description

PRIMARY STUDY OBJECTIVES

To show that the mean 24-hour IOP control obtained with BTFC (morning or evening) is statistically better to that with bimatoprost monotherapy given once on the evening.
To demonstrate that the fixed combination will provide a significantly better IOP control in the morning when dosed in the evening.
To test whether the mean 24-hour IOP control obtained with BTFC given once in the evening may be statistically better to that with BTFC given once in the morning.
To show whether there will be less 24-hour fluctuation of IOP with the evening dosing of BTFC.

STUDY POPULATION

Consecutive newly-diagnosed, or suitably washed-out patients with exfoliative glaucoma (XFG) who exhibit a mean untreated IOP greater than 25 mm Hg at baseline (10:00).

Enrollment

60 patients

Sex

All

Ages

39 to 81 years old

Volunteers

No Healthy Volunteers

Inclusion and exclusion criteria

Inclusion Criteria:

The patient is suffering from XFG (if the patient has bilateral XFG, both eyes will be treated, but the worse eye will be selected for the statistical analysis)
Patient is older than 39 years and younger than 85 years
Patient is able and willing to participate in the study for the whole duration of the follow up. Will sign the consent form.
At screening the untreated IOP at 10:00 (± 1 hr) is greater than 25 mm Hg and lower than 40 mm Hg
After bimatoprost run-in therapy the treated IOP at 10:00 (± 1 hr) is greater than 19 mm Hg