Glaucoma, Ocular Hypertension
Conditions
Keywords
OAG, OH, Open-angle glaucoma or ocular hypertension
Brief summary
The purpose of the study is to compare the IOP lowering efficacy of Travoprost/Brinzolamide dosed daily in the morning or evening, vs TRAVATAN dosed once daily in the evening, and vs. AZOPT dosed BID in patients with open-angle glaucoma or ocular hypertension.
Interventions
Sponsors
Alcon Research
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* 18 YOA or older * Either gender or any race * OAG or OHT * Currently on stable (at least 4 weeks) IOP lowering medication * IOP at screening visit ≥ 18mmHg in at least one eye * Mean IOP in same eye (at both eligibility 1&2 visits * 24 and 36 mmHg at 9AM * 21 and 36 mmHg at 11AM and 4PM * Able to discontinue use of IOP lowering medication for a minimum wash out period of 5 to 28 days prior to eligibility visit 1
Exclusion criteria
Related to disease condition being investigated (OAG or OHT) in either eye * Severe central visual field loss * Angle shaffer grade \< 2 * C/D ratio \>0.8(horizontal or vertical measurement) Related to ocular patient history or current ocular condition in either eye * BSCVA worse than 55 ETDRS letters read (equivalent to approximately 20/80 Snellen or 0.25 decimal) * Ocular infection or inflammation or laser surgery within the last 3 months * Intraocular surgery or trauma with the last 6 months * Any abnormality preventing reliable applanation tonometry * History or chronic, recurrently or current severe inflammatory disease * History of or current clinically significant or progressive retinal disease * History of or current ocular pathology(including severe dry eye) that would affect the conduct of the study Related to systemic or ocular medication in either eye * Allergy/hypersensitivity to study medications * Unable to discontinue glucocorticoid at least 4 weeks prior to the study or unable to remain off these medications during the study period * Use of oral CAIs during the study * Recent use (\<4 weeks prior to the study) of Aspirin (\>1 gram) * Less than 30 days stable dosing regimen of medications used on a chronic basis that may affect IOP * Therapy with another investigational agent within 30 days prior to the Screening Visit
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Mean IOP | 9, 11, and 16:00 time points at Week 12 |
Secondary
| Measure | Time frame |
|---|---|
| Mean diurnal IOP at Week 12 | results pooled across 9,11, and 16:00 time points |
Countries
Belgium
Outcome results
None listed