6-week proof-of-concept study of travoprost/brinzolamide ophthalmic suspension in subjects with open-angle glaucoma or ocular hypertension

Conditions: Glaucoma; Ocular Hypertension

Summary: the purpose of this study is to evaluate travoprost/brinzolamide fixed combination (trav/brinz) administered twice daily as compared to each of its marketed components (travatan z® solution and azopt® suspension) and to the unfixed combination of travatan z® plus azopt® in lowering intraocular pressure (iop).

this study was divided into two phases conducted in sequence. phase i was the screening/eligibility phase, which included a screening visit, followed by two eligibility visits. phase ii was the randomized, double-masked, 6-week treatment phase which included on-therapy visits at week 2 and week 6. travoprost was administered in 1 of 3 concentration levels (a-c), where a=lowest and c=highest.

Eligibility criteria:
inclusion criteria: * diagnosed with open-angle glaucoma (including open-angle glaucoma with pseudoexfoliation or pigment dispersion) or ocular hypertension; * iop within the protocol-specified range at both the eligibility 1 and 2 visits. mean iop must not be \>36 mmhg at any time point; * able to understand and sign an informed consent form; * other protocol-specified inclusion criteria may apply. exclusion criteria: * woman of childbearing potential who is currently pregnant, intends to become pregnant during the study period, breastfeeding, or not using adequate birth control methods to prevent pregnancy throughout the study; * unable to discontinue all iop-lowering ocular medication(s) per the appropriate washout schedule prior to the e1 visit; * chronic, recurrent or severe inflammatory eye disease; * ocular trauma within the past 6 months prior to the screening visit; * ocular infection or ocular inflammation within the past 3 months prior to the screening visit; * clinically relevant or progressive retinal disease such as retinal degeneration, diabetic retinopathy, or retinal detachment; * best-corrected visual acuity (bcva) score worse than 55 etdrs letters (equivalent to approximately 0.60 logmar, 20/80 snellen, or 0.25 decimal); * other ocular pathology (including severe dry eye) that may, in the opinion of the investigator, preclude the administration of a topical prostaglandin analogue or topical carbonic anhydrase inhibitor; * intraocular surgery within the past 6 months prior to the screening visit; * ocular laser surgery within the past 3 months prior to the screening visit; * any abnormality preventing reliable applanation tonometry; * any other conditions including severe illness which would make the subject, in the opinion of the investigator, unsuitable for the study; * history of hepatic or renal disease that would preclude the safe administration of a carbonic anhydrase inhibitor (cai) in the opinion of the investigator; * hypersensitivity to prostaglandin analogues, topical or oral cais, sulfonamide derivatives, or to any component of the study medications in the opinion of the investigator; * recent (within 4 weeks of the eligibility 1 visit) use of high dose (\> 1 g daily) salicylate therapy; * use of any additional topical or systemic ocular hypotensive medication during the study; * concurrent use of glucocorticoids administered by any route; * less than 30 days stable dosing regimen before the screening visit of any medications (excluding the iop-lowering treatments) or substances administered by any route and used on a chronic basis that may affect iop (ie, β adrenergic blocking agents); * therapy with another investigational agent within 30 days prior to the screening visit; * other protocol-specified exclusion criteria may apply.

Keywords: glaucoma ocular hypertension oag poag oht