The purpose of this research study is to demonstrate that the fixed combination brinz/brim used twice daily has a similar effect (both in terms of reduction of the eye pressure and possible side effects) as brinzolamide and brimonidine used twice…
ID
Source
Brief title
Condition
- Glaucoma and ocular hypertension
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Primary Efficacy:
• Mean diurnal IOP Change from Baseline at Month 3 (patient IOP change from
baseline averaged over the 9 AM and +2 hrs time points)
Secondary outcome
There are no secondary efficacy endpoints.
Background summary
Open-angle glaucoma and ocular hypertension are eye conditions associated with
abnormally high fluid pressure in the eye (called intraocular pressure of IOP).
If left untreated, elevated IOP may eventually cause damage to the optic nerve
and a loss of vision. Treatment for both open-angle glaucoma and ocular
hypertension is aimed at lowering pressure in the eye and there are different
types of medications that can be used for this. Among the pharmacological
treatments, the most commonly used are eye drops containing drugs of different
classes;
Among several possible drugs available for the treatment of elevated eye
pressure, the two that will be used in this study are *brinzolamide* (AZOPT®,
Brinzolamide 10mg/ml, Eye Drops, Solution) and *brimonidine* (Brimonidine
Tartrate 2 mg/ml, Eye Drops, Solution, available on the market in several
countries with different trade names, eg., ALPHAGAN). Brinzolamide belongs to
a class of drugs known as carbonic anhydrase inhibitors (CAI) that reduce eye
pressure by decreasing the production of fluid (aqueous humor) in the eye.
Brimonidine is an alpha 2 adrenergic agonists and can decrease the production
of fluid (aqueous humor) and also increase the rate it drains from the eye.
Both products are currently available and can be used alone or in combination
with other products when the treatment with only one drug is not sufficient to
decrease the eye pressure as desired.
Patients may already use both medications at the same time as directed by their
eye doctor; however, the combination of these two drugs in a single bottle
would be a more convenient way to use the medication, making it easier to
follow dosing instructions, and consequently, better maintain the eye pressure
levels.
Study objective
The purpose of this research study is to demonstrate that the fixed combination
brinz/brim used twice daily has a similar effect (both in terms of reduction of
the eye pressure and possible side effects) as brinzolamide and brimonidine
used twice daily as separate medications in concomitant administration.
Study design
Approximately 7 months (inclusive wash-out period), 2 arms, parallel groeps,
multicenter, double-masked, randomised, active-controlled study:
- Brinzolamide 10 mg/ml / Brimonidine 2 mg/ml eye drops suspension (+ for
masking: Vehicle eye drops, solution) (2X per day)
- Brinzolamide 10 mg/ml eye drops, suspension (2X per day) and Brimonidine 2
mg/ml eye drops, solution (2X per day)
Intervention
Not applicable
Study burden and risks
In a period of 6 months, patients need to come to the hospital 7 times for an
ophthalmic examination. each visit will take approximately 90 minutes of their
time. None of the tests are experimental.
All the patients will receive both brinzolamide and brimonidine, either as
separate medications or together in the same bottle. Like with all medicines,
these medications can cause side effects, although not everyone gets them. It
is expected that the possible side effects will be very similar in the two
groups and will be reflective of the side effects reported with brimonidine and
brinzolamide described below
The common side effects observed with brinzolamide:
In the body: include general side effects like a bitter or unusual taste in the
mouth (dysgeusia), headache, and dry mouth,
In the eye like blurred vision, eye irritation, eye pain, eye discharge, itchy
eye, dry eye, a feeling of something in the eye (foreign body sensation), red
eye, inflammation of the eyelid (blepharitis)
The most common side effects seen with brimonidine:
In the body: dry mouth, tiredness/drowsiness, headache, dizziness, abnormal
taste or general weakness.
In the eye: allergic reactions in the eye, follicles or white spots on the
see-through layer which covers the surface of the eye (conjunctival follicles),
blurred vision, red eyes, burning, stinging, a feeling of something in the eye
(foreign body sensation), itchy eyes, changes to the surface of the eye,
inflammation of the eyelid, inflammation of the see-through layer which covers
the surface of the eye, abnormal vision, sticky eyes, swelling of the eyelid or
see-through layer which covers the surface of the eye, sensitivity to light
(photophobia), irritation, eyelid redness, pain, dryness, erosion on the
surface of the eye and staining, tears or whitening of the see-through layer
which covers the surface of the eye.
Rijksweg 14
B-2870 Puurs
NL
Rijksweg 14
B-2870 Puurs
NL
Listed location countries
Age
Inclusion criteria
1) Patients 18 years of age or older, of either gender, and any race/ethnicity, diagnosed with open-angle glaucoma or ocular hypertension who in the opinion of the investigator are insufficiently controlled on monotherapy or are currently on multiple IOP-lowering medications.
2) Mean IOP measurements in at least one eye, the same eye(s), must be:
• >= 24 mmHg and <= 36 mmHg at the 9 AM time point and
• >= 21 mmHg and <= 36 mmHg at the 11 AM time point ,
at both Eligibility 1 and Eligibility 2 Visits, following wash-out of any IOP-lowering medication.
Mean IOP must not be > 36 mmHg at any time point.
3) Must be able to understand and sign an informed consent form that has been approved by an Independent Ethics Committee
Exclusion criteria
1. Women of childbearing potential (who are not postmenopausal for at least 1 year or surgically sterile) are excluded from participation if they are currently pregnant, have a positive result on the urine pregnancy test at Screening, or intend to become pregnant during the study period; are breast-feeding; are not in agreement to use adequate birth control methods (see the Manual of Procedures) to prevent pregnancy throughout the study.
2. Schaffer angle Grade < 2 as measured by gonioscopy (extreme narrow angle with complete or partial closure).
3. Cup/disc ratio (C/D) greater than 0.80 (horizontal or vertical measurement).
4. Severe central visual field loss. Severe central visual field loss is defined as a sensitivity of
less than or equal to 10 dB in at least 2 of the 4 visual field test points closest to the point of fixation.
5. Patients who cannot safely undergo the initial wash-out period discontinuing all IOP-lowering ocular medication(s) for a minimum of 5 (± 1) to 28 (± 1) days prior to E1 Visit.
6. Chronic, recurrent or severe inflammatory eye disease (ie, scleritis, uveitis, herpes keratitis).
7. Ocular trauma within the past 6 months.
8. Ocular infection or ocular inflammation within the past 3 months.
9. Clinically significant or progressive retinal disease such as retinal degeneration, diabetic retinopathy, or retinal detachment.
10. Best-corrected visual acuity (BCVA) score worse than 55 ETDRS letters (equivalent to approximately 0.60 logMAR, 20/80 Snellen, or 0.25 decimal).
11. Other ocular pathology (including severe dry eye) that may, in the opinion of the Investigator, preclude the administration of α-adrenergic agonist and/or topical carbonic anhydrase inhibitor (CAI).
12. Intraocular surgery within the past 6 months.
13. Ocular laser surgery within the past 3 months.
14. Any abnormality preventing reliable applanation tonometry.
15. Any other conditions including severe illness which would make the patient, in the opinion of the Investigator, unsuitable for the study.
16. History of active, severe, unstable or uncontrolled cardiovascular (eg, coronary insufficiency, hypertension, Raynaud*s phenomenon, orthostatic hypotension, thromboangiitis obliterans), cerebrovascular (eg, cerebral insufficiency), hepatic, or renal disease that would preclude
the safe administration of a topical α-adrenergic agonist or CAI in the opinion of the investigator.
17. Recent (within 4 weeks of the E1 Visit) use of high-dose (>1 g daily) salicylate therapy.
18. Current or anticipated treatment with any psychotropic drugs that augment adrenergic response (eg, desipramine, amitriptyline).
19. Concurrent use of monoamine oxidase inhibitors (MAOI).
20. Concurrent use of glucocorticoids administered by any route.
21. Therapy with another investigational agent within 30 days prior to the Screening Visit.
22. Hypersensitivity to α-adrenergic agonist drugs, topical or oral CAIs, sulfonamide derivatives, or to any component of the study medications in the opinion of the Investigator.
23. Less than 30 days stable dosing regimen before the Screening Visit of any medications or substances administered by any route and used on a chronic basis that may affect IOP,
including but not limited to β-adrenergic blocking agents.
24. Use of any additional topical or systemic ocular hypotensive medication during the study.
Design
Recruitment
Medical products/devices used
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| EudraCT | EUCTR2010-024513-31-NL |
| ClinicalTrials.gov | NCT01309204 |
| CCMO | NL36677.008.11 |