a three part study of mgv354 in ocular hypertension or glaucoma

Conditions: Ocular Hypertension; Open-Angle Glaucoma

Summary: the purpose of this study is to determine if the clinical profile of topical-ocular mgv354 merits further development for the indication of lowering intraocular pressure (iop).

part 1 will evaluate the safety and tolerability of single ascending doses of mgv354 compared to placebo in healthy male and female subjects. part 2 will evaluate the safety and tolerability of mgv354 in a multiple ascending dose design (two highest tolerated doses from part 1) compared to placebo when administered for 7 days to patients with ocular hypertension or glaucoma. part 3 will explore the safety, tolerability and efficacy of a single dose level of mgv354 (maximum tolerated dose) compared to placebo when administered for 7 days in patients with ocular hypertension or glaucoma.

Eligibility criteria:
inclusion criteria: * documented informed consent. * part 1: 18 to 70 years of age; * parts 2 and 3: 18 years of age or older; * able to communicate well with the investigator and understand and comply with the requirements of the study; * body mass index (bmi) between 18 and 39; * in case of contact lens wear, willing to remove lenses 30 minutes before the first assessment until the end of the study. corrective spectacles may be worn as needed. * sitting vital signs (systolic and diastolic blood pressure and pulse rate) within normal ranges as specified in the protocol; * part 1 (healthy volunteers): in good health as determined by past medical history, physical examination, vital signs, electrocardiogram, and laboratory tests at screening. * parts 2 and 3 (patients): diagnosed with open-angle glaucoma or confirmed ocular hypertension; mean iop measurements in at least one eye after washout as specified in the protocol * other protocol-specified inclusion criteria may apply. exclusion criteria: * history of hypersensitivity to any of the study drugs or to drugs of similar chemical classes; * history of or current presence of clinically significant ecg abnormalities or arrhythmias; * history of malignancy of any organ system (other than localized basal cell carcinoma of the skin or in-situ cervical or breast cancer), treated or untreated, within the past 5 years; * known clinical history of heart failure, myocardial infarction, or stroke; * exposure during the four weeks preceding the screening visit to any topical, inhaled, or systemic corticosteroids; * angle grade less than grade 2 in either eye; * any abnormality, including corneal thickness \> 620 microns, preventing reliable applanation tonometry; * pregnant or lactating women and women of child-bearing potential; * sexually active males must agree to use a condom during intercourse while taking drug and for 6 days after stopping mgv354 medication and should not father a child in this period; * positive hiv, hepatitis b ag or hepatitis c ab test result at screening; * abnormal liver function tests; * history or presence of impaired renal function; * part 1 (healthy volunteers): use of any new prescription drugs or herbal supplements within four (4) weeks prior to initial dosing, and/or new over-the-counter (otc) medication, dietary supplements (vitamins included) within two (2) weeks prior to initial dosing. * parts 2 and 3 (patients): patients with related disease condition(s) including any form of glaucoma other than open-angle glaucoma and pseudoexfoliation and/or pigment dispersion components; patients who cannot safely discontinue use of all topical ocular and/or systemic iop-lowering medication according to protocol-specified washout schedule; patients with ocular diseases or conditions as specified in the protocol; patients taking certain medications as specified in the protocol; * other protocol-specified exclusion criteria may apply.

Keywords: ocular hypertension open-angle glaucoma poag glaucoma