A Three Part Study of MGV354 in Ocular Hypertension or Glaucoma

NCT ID: NCT02743780

Last Updated: 2018-07-02

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1/PHASE2
• Total Enrollment: 191 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-03-02
• Study Completion Date: 2016-09-20

Brief 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).

Detailed Description

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.

Conditions

Ocular Hypertension; Open-Angle Glaucoma

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: OTHER
• Blinding Strategy: DOUBLE

Study Groups

MGV354

Part 3: MGV354 ophthalmic suspension, 1 drop in both eyes once per day for 7 days

Group Type: EXPERIMENTAL

MGV354 ophthalmic suspension

Intervention Type: DRUG

Placebo

Part 3: MGV354 placebo, 1 drop in both eyes once per day for 7 days

Group Type: PLACEBO_COMPARATOR

MGV354 placebo

Intervention Type: DRUG

Inactive ingredients used as placebo comparator

Interventions

MGV354 ophthalmic suspension

Intervention Type: DRUG

MGV354 placebo

Inactive ingredients used as placebo comparator

Intervention Type: DRUG

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

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;

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Novartis Institute for BioMedical Research

UNKNOWN

Sponsor Role: collaborator

Alcon Research

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Clinical Science Expert, NIBR

Role: STUDY_DIRECTOR

Novartis Institute for BioMedical Research

References

Stacy R, Huttner K, Watts J, Peace J, Wirta D, Walters T, Sall K, Seaman J, Ni X, Prasanna G, Mogi M, Adams C, Yan JH, Wald M, He Y, Newton R, Kolega R, Grosskreutz C. A Randomized, Controlled Phase I/II Study to Evaluate the Safety and Efficacy of MGV354 for Ocular Hypertension or Glaucoma. Am J Ophthalmol. 2018 Aug;192:113-123. doi: 10.1016/j.ajo.2018.05.015. Epub 2018 May 24.

Reference Type: DERIVED

PMID: 29802818 (View on PubMed)

Other Identifiers

MGV354-2201

Identifier Type: -

Identifier Source: org_study_id