Clinical trial NCT02743780 (phase 1/phase 2, status: completed)
Conditions: ocular hypertension, open-angle glaucoma
ICD codes: H40.053, H40.051, H40.052, H40.059, H40.10X0, H40.10X1, H40.10X2, H40.10X3, H40.10X4, H40.1130, H40.1131
Drugs: mgv354 ophthalmic suspension, mgv354 placebo
SMILES: CN1C(=O)C=C(N2CCC[C@@H](N)C2)N(CC2=C(C=CC=C2)C#N)C1=O
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.