Ocular HypertensionPhase 1/2NCT02743780

A Three Part Study of MGV354 in Ocular Hypertension or Glaucoma

A Phase 1/2 study testing MGV354 ophthalmic suspension in people with Ocular Hypertension and Open-Angle Glaucoma, run by Alcon Research.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial 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). Read more about this study

Who is it for?: Ages 18 years and olderHealthy volunteers can take part
Conditions the study is for: Ocular Hypertension, Open-Angle Glaucoma
What is being tested?: MGV354 ophthalmic suspension
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 191 participants
Where: No sites listed yet
Study dates: 2 Mar 2016to 20 Sep 2016
Phase: Phase 1/2
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
All sexes
Healthy volunteers accepted
Adult, Older adult

Who may be able to join

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.

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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.

Who cannot join

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;

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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.

About this study

Official title: A Three Part, First-in-human, Randomized, Double-masked, Placebo-Controlled, Safety, Tolerability and Early Efficacy Study of MGV354 in Healthy Subjects and in Patients With Ocular Hypertension or Glaucoma

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).

Read the 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
Being tested: MGV354 ophthalmic suspension, MGV354 placebo
Keywords: Ocular Hypertension, Open-Angle Glaucoma, POAG, Glaucoma
Medical subject headings: Ocular Hypertension, Glaucoma, Open-Angle, Glaucoma

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

MGV354 ophthalmic suspensionDrug
MGV354 placeboDrug
Inactive ingredients used as placebo comparator

Study groups in NCT02743780
Study group	Role	What they receive
MGV354	Experimental	Part 3: MGV354 ophthalmic suspension, 1 drop in both eyes once per day for 7 days Receives: Drug: MGV354 ophthalmic suspension
Placebo	Placebo comparator	Part 3: MGV354 placebo, 1 drop in both eyes once per day for 7 days Receives: Drug: MGV354 placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

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.
Measured: 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.
Measured: Baseline, Day 8

Secondary outcomes (12)

Part 3: Change From Baseline in IOP at 36 Hours and 48 Hours Post Day 7 Administration
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.
Measured: Baseline, up to Day 9
Part 1: Maximum Observed Concentration [Cmax (ng/mL)]
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.
Measured: 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)]
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.
Measured: 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)]
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.
Measured: 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)]
Based on plasma samples collected at pre-determined nominal time points, dependent on observed concentrations. Approximately 2 mL of venous blood was to be collected at each time point.
Measured: Pre-dose to 120 hours post-dose
Part 1: Area Under the Concentration-time Curve From 0 to Infinity [AUCinf (ng*h/mL)]
Based on plasma samples collected at pre-determined nominal time points, dependent on observed concentrations. Approximately 2 mL of venous blood was to be collected at each time point.
Measured: Pre-dose to 120 hours post-dose
Part 1: Terminal Elimination Half-life [t1/2 (h)]
Based on plasma samples collected at pre-determined nominal time points, dependent on observed concentrations. Approximately 2 mL of venous blood was to be collected at each time point.
Measured: Pre-dose to 120 hours post-dose
Part 2: Maximum Observed Concentration [Cmax (ng/mL)]
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.
Measured: Up to Day 7
Part 2: Time to Reach Maximum Concentration [Tmax (h)]
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.
Measured: Up to Day 7
Part 2: Area Under the Concentration-time Curve From 0 to the End of the Dosing Interval Tau [AUCtau (ng*h/mL)]
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.
Measured: Up to Day 7
Part 2: Accumulation Ratio (Racc)
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.
Measured: Day 7
Part 3: Observed Concentration at 12 Hours Following Drug Administration [C12 (ng/mL)]
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.
Measured: Up to Day 8

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

2 Mar 201620 Sep 2016

First posted19 Apr 2016 (estimated)
Study start2 Mar 2016
Primary completion20 Sep 2016
Study completion20 Sep 2016

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (1)Papers the sponsor has linked to this study.
Other trials for Ocular HypertensionStudies of the same condition, open and under way.
More trials run by Alcon ResearchThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 1/2
Primary purpose: Other
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind
Who is masked: Participant, Investigator
Enrolment: 191 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02743780
Sponsor's protocol ID: MGV354-2201
Status last verified: Aug 2017
First submitted: 14 Apr 2016
Last updated: 2 Jul 2018
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

Publications

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.
PubMed 29802818

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

Official record

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Study at a glance

From the registry record, last updated by the sponsor on 2 Jul 2018. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Three Part, First-in-human, Randomized, Double-masked, Placebo-Controlled, Safety, Tolerability and Early Efficacy Study of MGV354 in Healthy Subjects and in Patients With Ocular Hypertension or Glaucoma
ClinicalTrials.gov ID: NCT02743780
Acronym / sponsor ID: MGV354-2201
Conditions: Ocular Hypertension, Open-Angle Glaucoma
Keywords: Ocular Hypertension, Open-Angle Glaucoma, POAG, Glaucoma
Phase: Phase 1/2
Study type: Interventional
Recruitment status: Completed
Enrolment: 191 participants (actual)
Lead sponsor: Alcon ResearchIndustry (pharma, biotech, devices)
Collaborators: Novartis Institutes for BioMedical Research
Study start: 2 Mar 2016 (actual)
Primary completion: 20 Sep 2016 (actual)
Study completion: 20 Sep 2016 (actual)
First posted: 19 Apr 2016 (estimated)
Results: Posted 31 Aug 2017

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

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

Study design

Primary purpose: Other
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind (participant, investigator)
Number of arms: 2

Arm	Type	Receives
MGV354	Experimental	Drug: MGV354 ophthalmic suspensionPart 3: MGV354 ophthalmic suspension, 1 drop in both eyes once per day for 7 days
Placebo	Placebo comparator	Drug: MGV354 placeboPart 3: MGV354 placebo, 1 drop in both eyes once per day for 7 days

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Accepted
Age groups: Adult, Older adult

Key inclusion criteria (10 listed)

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;

Key exclusion criteria (15 listed)

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;

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
MGV354 ophthalmic suspension	Drug	MGV354
MGV354 placeboInactive ingredients used as placebo comparator	Drug	Placebo

Primary outcome

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

12 secondary outcomes

Part 3: Change From Baseline in IOP at 36 Hours and 48 Hours Post Day 7 Administration
Time frame: Baseline, up to Day 9
Part 1: Maximum Observed Concentration [Cmax (ng/mL)]
Time frame: 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)]
Time frame: 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)]
Time frame: 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)]
Time frame: Pre-dose to 120 hours post-dose
Part 1: Area Under the Concentration-time Curve From 0 to Infinity [AUCinf (ng*h/mL)]
Time frame: Pre-dose to 120 hours post-dose
Part 1: Terminal Elimination Half-life [t1/2 (h)]
Time frame: Pre-dose to 120 hours post-dose
Part 2: Maximum Observed Concentration [Cmax (ng/mL)]
Time frame: Up to Day 7
Part 2: Time to Reach Maximum Concentration [Tmax (h)]
Time frame: Up to Day 7
Part 2: Area Under the Concentration-time Curve From 0 to the End of the Dosing Interval Tau [AUCtau (ng*h/mL)]
Time frame: Up to Day 7
Part 2: Accumulation Ratio (Racc)
Time frame: Day 7
Part 3: Observed Concentration at 12 Hours Following Drug Administration [C12 (ng/mL)]
Time frame: Up to Day 8

Results and safety

Results posted to the registry on 31 Aug 2017, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
MGV354 0.01%	6	6
MGV354 0.03%	6	6
MGV354 0.1%	6	6
MGV354 0.3%	6	6
Placebo	8	8

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

Time frame: Baseline, Day 8. Least squares mean (Standard Error). Unit: mmHg

Measure	MGV354 0.1% n = 24	Placebo n = 25
Value	-0.6 (0.43)	-1.1 (0.42)

Population analysed: Full Analysis Set

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

Time frame: Baseline, Day 8. Least squares mean (Standard Error). Unit: mmHg

Measure	MGV354 0.1% n = 24	Placebo n = 25
Change from Baseline (BL) at 8 AM	0.1 (0.57)	-1.5 (0.56)
Change from BL at 10 AM	-0.4 (0.57)	-1.5 (0.56)
Change from BL at noon	-0.2 (0.57)	-0.2 (0.56)
Change from BL at 4 PM	-1.2 (0.57)	-1.4 (0.56)
Change from BL at 8 PM	-1.1 (0.57)	-0.7 (0.56)

Population analysed: Full Analysis Set

12 secondary outcomes are reported in the full results.

Adverse events

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).. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
MGV354 0.01% Part 1	0 of 6 (0%)	0 of 6 (0%)	0 of 6
MGV354 0.03% Part 1	0 of 6 (0%)	0 of 6 (0%)	0 of 6
MGV354 0.1% Part 1	0 of 6 (0%)	3 of 6 (50%)	0 of 6
MGV354 0.3% Part 1	0 of 6 (0%)	6 of 6 (100%)	0 of 6
Placebo Part 1	0 of 8 (0%)	0 of 8 (0%)	0 of 8
MGV354 0.03% Part 2	0 of 6 (0%)	6 of 6 (100%)	0 of 6
MGV354 0.1% Part 2	0 of 6 (0%)	6 of 6 (100%)	0 of 6
Placebo Part 2	0 of 4 (0%)	1 of 4 (25%)	0 of 4
MGV354 0.1% Part 3	0 of 25 (0%)	23 of 25 (92%)	0 of 25
Placebo Part 3	0 of 25 (0%)	5 of 25 (20%)	0 of 25

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 2 Jul 2018.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 29802818Stacy 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.

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Clinical Science Expert, NIBR study director

Novartis Institutes for BioMedical Research

Questions about this trial

What is this clinical trial studying?

A Phase 1/2 study testing MGV354 ophthalmic suspension in people with Ocular Hypertension and Open-Angle Glaucoma, run by Alcon Research.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 10 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 2 Jul 2018. Status can change between updates, so confirm with the study contact before making plans.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this combined phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 31 Aug 2017). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Part 3: Change in Diurnal IOP (Averaged Over 8 AM, 10 AM, Noon, 4 PM, and 8 PM) From Baseline to Day 8 (time frame: Baseline, Day 8). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02743780, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Jul 2018.