A Three Part Study of MGV354 in Ocular Hypertension or Glaucoma

• Status: Completed
• Trial end date: 2016-09-20
• Target enrollment: 0
• Participant gender: All

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).

• Phase: Phase 1/Phase 2
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Alcon Research
• Collaborator: Novartis Institute for BioMedical Research
• Treatments: MGV354

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.