A Three Part Study of MGV354 in Ocular Hypertension or Glaucoma

NCT02743780 | Completed Phase 1 Results

• 1 other identifier: MGV354-2201
• Study Type: interventional
• Target: 191
• Locations: 0 countries
• Sites: N/A

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).

Conditions

Ocular Hypertension; Open-Angle Glaucoma

Keywords

Ocular Hypertension; Open-Angle Glaucoma; POAG; Glaucoma

Outcome Measures

Primary Outcomes (2)

• Part 3: Change in Diurnal IOP (Averaged Over 8 AM, 10 AM, Noon, 4 PM, and 8 PM) From Baseline to Day 8

  IOP (fluid pressure inside the eye) was assessed using Goldmann applanation tonometry and reported in mmHg. Diurnal IOP was defined as the average of the five time points measured (8 AM, 10 AM, noon, 4 PM, and 8 PM). Baseline diurnal IOP was the average of IOP measurements obtained at the 2 eligibility visits. Change from baseline was calculated by taking the change at each time point from baseline to Day 8 and averaging the available changes. A more negative change from baseline indicates a greater improvement, i.e., a reduction of IOP. Only one eye (study eye) contributed to the analysis.

  Baseline, Day 8

• Part 3: Change in IOP From Baseline to Day 8 at 8 AM, 10 AM, Noon, 4 PM, and 8 PM

  IOP (fluid pressure inside the eye) was assessed using Goldmann applanation tonometry and reported in mmHg. Baseline IOP was the average of IOP measurements obtained at the 2 eligibility visits. Change from baseline was calculated by taking the change at each time point from baseline to Day 8. A more negative change from baseline indicates a greater improvement, i.e., a reduction of IOP. Only one eye (study eye) contributed to the analysis.

  Baseline, Day 8

Secondary Outcomes (12)

• Part 3: Change From Baseline in IOP at 36 Hours and 48 Hours Post Day 7 Administration

  Baseline, up to Day 9

• Part 1: Maximum Observed Concentration [Cmax (ng/mL)]

  Pre-dose, .5, 2, 4, 6, 12, 24, 48, 72, 96, 120 hours post-dose, and Day 7 post-dose

• Part 1: Time to Reach Maximum Concentration [Tmax (h)]

  Pre-dose, .5, 2, 4, 6, 12, 24, 48, 72, 96, 120 hours post-dose, and Day 7 post-dose

• Part 1: Area Under the Plasma Concentration-time Curve From Time Zero to the Time of the Last Quantifiable Concentration [AUClast (ng*h/mL)]

  Pre-dose, .5, 2, 4, 6, 12, 24, 48, 72, 96, 120 hours post-dose, and Day 7 post-dose

• Part 1: Area Under the Plasma Concentration-time Curve From Time Zero to 120 Hours Post Dose [AUC0-120 (ng*h/mL)]

  Pre-dose to 120 hours post-dose

Study Arms (2)

MGV354

EXPERIMENTAL

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

Drug: MGV354 ophthalmic suspension

Placebo

PLACEBO COMPARATOR

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

Drug: MGV354 placebo

Interventions

MGV354 ophthalmic suspension DRUG

MGV354

MGV354 placebo DRUG

Inactive ingredients used as placebo comparator

Placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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;

Sponsors & Collaborators

• Alcon Research: lead
• Novartis Institute for BioMedical Research: collaborator

Related Publications (1)

• 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.

  PMID: 29802818 DERIVED

MeSH Terms

Conditions

Ocular Hypertension; Glaucoma, Open-Angle; Glaucoma

Condition Hierarchy (Ancestors)

Eye Diseases

Results Point of Contact

• Title: Translational Medicine Expert II, TM-Ophthalmic
• Organization: Alcon, A Novartis Division

alcon.medinfo@alcon.com

1-888-451-3937

Study Officials

• Clinical Science Expert, NIBR

  Novartis Institute for BioMedical Research

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 14, 2016
• First Posted: April 19, 2016
• Study Start: March 2, 2016
• Primary Completion: September 20, 2016
• Study Completion: September 20, 2016
• Last Updated: July 2, 2018
• Results First Posted: August 31, 2017

Record last verified: 2017-08