18 and older, any sex, with Ocular Hypertension or Open-Angle Glaucoma. Patients with the condition only — healthy volunteers not accepted.
Results — posted to ClinicalTrials.gov
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
Part 3: Change in Diurnal IOP (Averaged Over 8 AM, 10 AM, Noon, 4 PM, and 8 PM) From Baseline to Day 8Primary· Baseline, 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.
Group
Value
95% CI
MGV354 0.1%
-0.6
± 0.43
Placebo
-1.1
± 0.42
Part 3: Change in IOP From Baseline to Day 8 at 8 AM, 10 AM, Noon, 4 PM, and 8 PMPrimary· Baseline, Day 8
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.
Change from Baseline (BL) at 8 AM
Group
Value
95% CI
MGV354 0.1%
0.1
± 0.57
Placebo
-1.5
± 0.56
Change from BL at 10 AM
Group
Value
95% CI
MGV354 0.1%
-0.4
± 0.57
Placebo
-1.5
± 0.56
Change from BL at noon
Group
Value
95% CI
MGV354 0.1%
-0.2
± 0.57
Placebo
-0.2
± 0.56
Change from BL at 4 PM
Group
Value
95% CI
MGV354 0.1%
-1.2
± 0.57
Placebo
-1.4
± 0.56
Change from BL at 8 PM
Group
Value
95% CI
MGV354 0.1%
-1.1
± 0.57
Placebo
-0.7
± 0.56
Part 3: Change From Baseline in IOP at 36 Hours and 48 Hours Post Day 7 AdministrationSecondary· Baseline, up to Day 9
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 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.
Change from Baseline at 36 hours post Day 7 dose
Group
Value
95% CI
MGV354 0.1%
-1.58
± 3.574
Placebo
-1.09
± 2.209
Change from Baseline at 48 hours post Day 7 dose
Group
Value
95% CI
MGV354 0.1%
-1.39
± 3.282
Placebo
-0.12
± 2.541
Part 1: Maximum Observed Concentration [Cmax (ng/mL)]Secondary· Pre-dose, .5, 2, 4, 6, 12, 24, 48, 72, 96, 120 hours post-dose, and Day 7 post-dose
Based on plasma samples collected at pre-determined nominal time points, dependent on observed concentrations. Approximately 2 mL of venous blood was collected at each time point. Cmax is reported as mass/volume.
Group
Value
95% CI
MGV354 0.03%
0.073
± 0.013
MGV354 0.1%
0.098
± 0.032
MGV354 0.3%
0.327
± 0.178
Part 1: Time to Reach Maximum Concentration [Tmax (h)]Secondary· Pre-dose, .5, 2, 4, 6, 12, 24, 48, 72, 96, 120 hours post-dose, and Day 7 post-dose
Based on plasma samples collected at pre-determined nominal time points, dependent on observed concentrations. Approximately 2 mL of venous blood was collected at each time point.
Group
Value
95% CI
MGV354 0.03%
0.483
0.483 – 23.833
MGV354 0.1%
0.559
0.500 – 2.033
MGV354 0.3%
0.575
0.567 – 1.983
Part 1: Area Under the Plasma Concentration-time Curve From Time Zero to the Time of the Last Quantifiable Concentration [AUClast (ng*h/mL)]Secondary· Pre-dose, .5, 2, 4, 6, 12, 24, 48, 72, 96, 120 hours post-dose, and Day 7 post-dose
Based on plasma samples collected at pre-determined nominal time points, dependent on observed concentrations. Approximately 2 mL of venous blood was collected at each time point. AUClast is reported as mass\*time/volume.
Group
Value
95% CI
MGV354 0.03%
0.213
± 0.336
MGV354 0.1%
0.157
± 0.043
MGV354 0.3%
1.611
± 1.484
Part 2: Maximum Observed Concentration [Cmax (ng/mL)]Secondary· Up to Day 7
Based on plasma samples collected at pre-determined nominal time points, dependent on observed concentrations. Approximately 2 mL of venous blood was collected at each time point. Cmax is reported as mass/volume.
Day 1
Group
Value
95% CI
MGV354 0.03%
0.077
± 0.026
MGV354 0.1%
0.139
± 0.034
Day 7
Group
Value
95% CI
MGV354 0.03%
0.132
± 0.054
MGV354 0.1%
0.188
± 0.070
Part 2: Time to Reach Maximum Concentration [Tmax (h)]Secondary· Up to Day 7
Based on plasma samples collected at pre-determined nominal time points, dependent on observed concentrations. Approximately 2 mL of venous blood was collected at each time point.
Day 1
Group
Value
95% CI
MGV354 0.03%
0.533
0.500 – 0.583
MGV354 0.1%
0.567
0.550 – 0.583
Day 7
Group
Value
95% CI
MGV354 0.03%
0.550
0.483 – 0.550
MGV354 0.1%
0.533
0.483 – 1.967
Part 2: Area Under the Concentration-time Curve From 0 to the End of the Dosing Interval Tau [AUCtau (ng*h/mL)]Secondary· Up to Day 7
Based on plasma samples collected at pre-determined nominal time points, dependent on observed concentrations. Approximately 2 mL of venous blood was collected at each time point. AUCtau is reported as mass\*time/volume.
Day 1
Group
Value
95% CI
MGV354 0.1%
0.723
± NA
Day 7
Group
Value
95% CI
MGV354 0.03%
0.392
± 0.444
MGV354 0.1%
1.461
± 1.043
Part 2: Accumulation Ratio (Racc)Secondary· Day 7
Accumulation Ratio was derived using Cmax on Day 7 versus Cmax on Day 1. Approximately 2 mL of venous blood was collected at each time point.
Group
Value
95% CI
MGV354 0.03%
1.893
± 1.038
MGV354 0.1%
1.391
± 0.366
Part 3: Observed Concentration at 12 Hours Following Drug Administration [C12 (ng/mL)]Secondary· Up to Day 8
Based on plasma samples collected at pre-determined nominal time points, dependent on observed concentrations. Approximately 2 mL of venous blood was collected at each time point. C12 is reported as mass/volume.
Day 2
Group
Value
95% CI
MGV354 0.1%
0.0881
± 0.03964
Day 8
Group
Value
95% CI
MGV354 0.1%
0.1488
± 0.11026
Adverse events — posted to ClinicalTrials.gov
Time frame: Adverse events (AEs) were collected from time of consent for the duration of a subject's participation in the study (Part 1: up to 37 days, Part 2: up to 50 days, and Part 3: up to 59 days)..
Reporting threshold: 5%.
Adverse-event reports describe events observed during the trial — not all are caused by the drug.
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).
Publications & conference data
1 peer-reviewed publication reference this trial (live from Europe PMC):
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Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Alcon Research
Last refreshed: 2 July 2018
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT02743780.