Open-angle Glaucoma, Ocular HypertensionPhase 2NCT03216902

A Phase IIb Safety and Efficacy Study of DE-126 Ophthalmic Solution in Primary Open-Angle Glaucoma or Ocular Hypertension- Angel Study

A Phase 2 study testing Topical ultra-low dose of DE-126 Ophthalmic Solution, Topical low dose of DE-126 Ophthalmic Solution and Topical medium dose of DE-126 Ophthalmic Solution in people with Open-angle Glaucoma, Ocular Hypertension, run by Santen Inc. at 17 sites in 2 countries.

Completed

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

Official record

Search all trials

Trial summary

Treatment of elevated pressure in the eye (Intraocular pressure, or 'IOP') with eye drop medications has been shown to be effective in delaying or preventing the progression of glaucoma, and it is the only proven method for reducing the risk of glaucomatous visual field loss. Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Open-angle Glaucoma, Ocular Hypertension
What is being tested?: Topical ultra-low dose of DE-126 Ophthalmic Solution, Topical low dose of DE-126 Ophthalmic Solution and Topical medium dose of DE-126 Ophthalmic Solution
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 241 participants
Where: 17 sitesin 2 countries
Study dates: 25 Jul 2017to 27 Feb 2018
Phase: Phase 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
No healthy volunteers
Adult, Older adult

Who may be able to join

Provide signed written informed consent
Diagnosis of POAG or OHT in both eyes
Qualifying corrected visual acuity in each eye
Qualifying central corneal thickness in each eye
Qualifying Day 1 IOP measurement at 3 time-points in both eyes
Qualifying Anterior chamber angle

Who cannot join

History of ocular surgery specifically intended to lower IOP
Subjects who cannot safely discontinue use of ocular hypotensive medications during the wait/washout period
Advanced glaucoma in either eye
Any corneal abnormality or other condition interfering with or preventing reliable Goldmann applanation tonometry
Any ocular surgery or ocular laser treatment within 90 days prior to Visit 1 (Screening) and throughout the study in either eye
Females who are pregnant, nursing, or planning a pregnancy

Trial locations and contacts

17 sites in 2 countries.

Country

City, postcode or hospital

17 sites in 2 countries

United States12 sites

Sall Research Medical Center, Inc
Artesia, California, 90701
Keystone Research Ltd SMO/Texan Eye, PA
Austin, Texas, 78731
Mundorf Eye Center
Charlotte, North Carolina, 28204
Cornerstone Health Care, LLC
High Point, North Carolina, 27262
Shettle Eye Research, Inc.
Largo, Florida, 33773
North Valley Eye Medical Group
Mission Hills, California, 91345
Clayton Eye Clinical Research, LLC
Morrow, Georgia, 30260
Eye Research Foundation, INC
Newport Beach, California, 92657
North Bay Eye Associates, Inc.
Petaluma, California, 94954
Rochester Ophthalmological Group, PC
Rochester, New York, 14618
Coastal Research Associates, LLC
Roswell, Georgia, 30076
Keystone Research LTD SMO/Medical Center Ophthalmology Assoc.
San Antonio, Texas, 78240

Other trials in United States

Japan5 sites

Murakami Karindoh Hospital
Fukuoka-shi, Fukuoka
Nagasaka Eye Clinic
Nagoya-shi, Aichi
Sugiura Eye Clinic
Osaka-shi, Osaka
Sapporo Katoh Ophthalmology Clinic
Sapporo-shi, Hokkaido
Dogenzaka Kato Eye Clinic
Shibuya-ku, Tokyo

Other trials in Japan

About this study

Official title: A Phase IIb, Randomized, Observer-Masked, Placebo- and Active-Controlled, Parallel-Group, Multinational and Multicenter Study Assessing the Safety and Efficacy of DE-126 Ophthalmic Solution in Subjects With Primary Open-Angle Glaucoma or Ocular Hypertension- Angel Study

This study is being conducted to determine how well DE-126 ophthalmic solution works (efficacy) in safely lowering IOP when dosed as topical eyedrops. This study will evaluate the safety and efficacy of four (4) concentrations of DE-126, when compared with latanoprost (0.005%) eye drops in patients with primary open-angle glaucoma or ocular hypertension.

The IOP will be measured at 3 different times throughout the day, over 6 total visits during a 3-month treatment period (with up to 4 extra weeks observation if the patient must stop taking current eye drops to lower IOP). Safety assessments will be done throughout the study, including ocular signs and symptoms, vital signs, and clinical laboratory tests. While the most important time-point to measure IOP in this study and evaluate efficacy will be at the final study visit (month 3), IOP values will also be evaluated at other visits throughout the 3-month treatment period.

Conditions: Open-angle Glaucoma, Ocular Hypertension
Being tested: Vehicle of DE-126 Ophthalmic Solution, high dose of DE-126 Ophthalmic Solution, Topical ultra-low dose of DE-126 Ophthalmic Solution, Topical low dose of DE-126 Ophthalmic Solution, Topical medium dose of DE-126 Ophthalmic Solution, Topical high dose of DE-126 Ophthalmic Solution
Keywords: Glaucoma
Medical subject headings: Glaucoma, Open-Angle, Ocular Hypertension, Glaucoma

What participants receive

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

Vehicle of DE-126 Ophthalmic Solution, high dose of DE-126 Ophthalmic SolutionDrug
Vehicle of DE-126 Ophthalmic Solution dosed once daily for 6weeks, followed by high dose of DE-126 dosed once daily for 6 additional weeks
Topical ultra-low dose of DE-126 Ophthalmic SolutionDrug
Topical ultra-low dose of DE-126 Ophthalmic Solution dosed once daily for 12 weeks
Topical low dose of DE-126 Ophthalmic SolutionDrug
Topical low dose of DE-126 Ophthalmic Solution dosed once daily for 12 weeks
Topical medium dose of DE-126 Ophthalmic SolutionDrug
Topical medium dose of DE-126 Ophthalmic Solution dosed once daily for 12 weeks
Topical high dose of DE-126 Ophthalmic SolutionDrug
Topical high dose of DE-126 Ophthalmic Solution dosed once daily for 12 weeks
0.005% Latanoprost Ophthalmic SolutionDrug
Also called Xalatan®
0.005% Latanoprost Ophthalmic Solution dosed once daily for 12 weeks

Study groups in NCT03216902
Study group	Role	What they receive
Placebo (Vehicle of DE-126) followed by high dose of DE-126	Placebo comparator	Not described Receives: Drug: Vehicle of DE-126 Ophthalmic Solution, high dose of DE-126 Ophthalmic Solution
Ultra-low dose 0.0005% DE-126	Experimental	Not described Receives: Drug: Topical ultra-low dose of DE-126 Ophthalmic Solution
Low dose 0.001% DE-126	Experimental	Not described Receives: Drug: Topical low dose of DE-126 Ophthalmic Solution
Medium dose 0.002% DE-126	Experimental	Not described Receives: Drug: Topical medium dose of DE-126 Ophthalmic Solution
High dose 0.003% DE-126	Experimental	Not described Receives: Drug: Topical high dose of DE-126 Ophthalmic Solution
0.005% Latanoprost	Active comparator	Not described Receives: Drug: 0.005% Latanoprost Ophthalmic Solution

What is being measured

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

Intraocular Pressure in the Study Eye at Month 3
Intraocular Pressure (IOP),the fluid pressure inside the eye was measured by the Goldmann applanation tonometer in millimeters mercury (mmHg) at 3 time-points throughout the day.
Measured: 9:00, 13:00 and 17:00 at Month 3

Secondary outcomes (9)

Intraocular Pressure in the Study Eye at Week 6
Intraocular Pressure (IOP),the fluid pressure inside the eye was measured by the Goldmann applanation tonometer in millimeters mercury (mmHg) at 3 time-points throughout the day.
Measured: 9:00, 13:00 and 17:00 at Week 6
Intraocular Pressure in the Study Eye at Week 1 and Week 2
Intraocular Pressure (IOP),the fluid pressure inside the eye was measured by the Goldmann applanation tonometer in millimeters mercury (mmHg) at 3 time-points throughout the day.
Measured: 9:00, 13:00 and 17:00 at Week 1 and Week 2
Mean Diurnal Intraocular Pressure in the Study Eye at Each Post-baseline Visit
Mean Diurnal IOP was defined as the mean of the IOP values at the three schedules timepoints (9:00, 13:00 and 17:00) at that visit for that subject.
Measured: Week 1, Week 2, Week 6 and Month 3.
Change From Baseline (CFB) in Mean Diurnal Intraocular Pressure in the Study Eye at Each Post-baseline Visit
Mean Diurnal IOP was defined as the mean of the IOP values at the three schedules timepoints (9:00, 13:00 and 17:00) at that visit for that subject.
Measured: Week 1, Week 2, Week 6 and Month 3.
Percent Change From Baseline (CFB) in Mean Diurnal Intraocular Pressure in the Study Eye at Each Post-baseline Visit
Mean Diurnal IOP was defined as the mean of the IOP values at the three schedules timepoints (9:00, 13:00 and 17:00) at that visit for that subject.
Measured: Week 1, Week 2, Week 6 and Month 3.
Change From Baseline (CFB) in Intraocular Pressure in the Study Eye at Three Time Points at Each Post-baseline Visit
Intraocular Pressure (IOP),the fluid pressure inside the eye was measured by the Goldmann applanation tonometer in millimeters mercury (mmHg) at 3 time-points throughout the day.
Measured: 9:00, 13:00 and 17:00 at Week 1, Week 2, Week 6 and Month 3.
Percent Change From Baseline (CFB) in Intraocular Pressure in the Study Eye at Three Time Points at Each Post-baseline Visit
Intraocular Pressure (IOP),the fluid pressure inside the eye was measured by the Goldmann applanation tonometer in millimeters mercury (mmHg) at 3 time-points throughout the day.
Measured: 9:00, 13:00 and 17:00 at Week 1, Week 2, Week 6 and Month 3.
Percentage of Subjects With Mean Diurnal Intraocular Pressure Reduction From Baseline ≥ 20%, 25% and 30% in the Study Eye at Each Post-baseline Visit
A Subject was a responder if the percent reduction from baseline in mean diurnal IOP in the study eye was ≥ 20%.
A Subject was a responder if the percent reduction from baseline in mean diurnal IOP in the study eye was ≥ 25%.
A Subject was a responder if the percent reduction from baseline in mean diurnal IOP in the study eye was ≥ 30%.
Measured: WeeK 1, Week 2, Week 6 and Month 3.
Percentage of Subjects With Mean Diurnal Intraocular Pressure ≤ 18 mmHg in the Study Eye at Each Post-baseline Visit
A subject was a responder if the mean diurnal IOP in the study eye was ≤ 18 mmHg.
Measured: Week 1, Week 2, Week 6 and Month 3.

Timeline

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

25 Jul 201727 Feb 2018

First posted13 Jul 2017
Study start25 Jul 2017
Primary completion27 Feb 2018
Study completion27 Feb 2018

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 Open-angle Glaucoma, Ocular HypertensionStudies of the same condition, open and under way.
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 2
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Single blind
Who is masked: Outcomes assessor
Enrolment: 241 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT03216902
Sponsor's protocol ID: 012601IN
Status last verified: Sep 2020
First submitted: 11 Jul 2017
Last updated: 23 Oct 2020
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: Yes
FDA-regulated device: No

Publications

Wirta DL, Kuwayama Y, Lu F, Shao H, Odani-Kawabata N. Phase 2b, Randomized, 3-Month, Dose-Finding Study of Sepetaprost in Patients with Primary Open-Angle Glaucoma or Ocular Hypertension: The ANGEL Study. J Ocul Pharmacol Ther. 2022 Apr;38(3):240-251. doi: 10.1089/jop.2021.0077. Epub 2022 Feb 15.
PubMed 35167779

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?

See locations

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All Open-angle Glaucoma, Ocular Hypertension trials

Study at a glance

From the registry record, last updated by the sponsor on 23 Oct 2020. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Phase IIb, Randomized, Observer-Masked, Placebo- and Active-Controlled, Parallel-Group, Multinational and Multicenter Study Assessing the Safety and Efficacy of DE-126 Ophthalmic Solution in Subjects With Primary Open-Angle Glaucoma or Ocular Hypertension- Angel Study
ClinicalTrials.gov ID: NCT03216902
Acronym / sponsor ID: 012601IN
Conditions: Open-angle Glaucoma, Ocular Hypertension
Keywords: Glaucoma
Phase: Phase 2
Study type: Interventional
Recruitment status: Completed
Enrolment: 241 participants (actual)
Lead sponsor: Santen Inc.Industry (pharma, biotech, devices)
Study start: 25 Jul 2017 (actual)
Primary completion: 27 Feb 2018 (actual)
Study completion: 27 Feb 2018 (actual)
First posted: 13 Jul 2017 (actual)
Results: Posted 23 Oct 2020

Clinical summary

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

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Single blind (outcomes assessor)
Number of arms: 6

Arm	Type	Receives
Placebo (Vehicle of DE-126) followed by high dose of DE-126	Placebo comparator	Drug: Vehicle of DE-126 Ophthalmic Solution, high dose of DE-126 Ophthalmic Solution
Ultra-low dose 0.0005% DE-126	Experimental	Drug: Topical ultra-low dose of DE-126 Ophthalmic Solution
Low dose 0.001% DE-126	Experimental	Drug: Topical low dose of DE-126 Ophthalmic Solution
Medium dose 0.002% DE-126	Experimental	Drug: Topical medium dose of DE-126 Ophthalmic Solution
High dose 0.003% DE-126	Experimental	Drug: Topical high dose of DE-126 Ophthalmic Solution
0.005% Latanoprost	Active comparator	Drug: 0.005% Latanoprost Ophthalmic Solution

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (6 listed)

Provide signed written informed consent
Diagnosis of POAG or OHT in both eyes
Qualifying corrected visual acuity in each eye
Qualifying central corneal thickness in each eye
Qualifying Day 1 IOP measurement at 3 time-points in both eyes

Key exclusion criteria (6 listed)

History of ocular surgery specifically intended to lower IOP
Subjects who cannot safely discontinue use of ocular hypotensive medications during the wait/washout period
Advanced glaucoma in either eye
Any corneal abnormality or other condition interfering with or preventing reliable Goldmann applanation tonometry
Any ocular surgery or ocular laser treatment within 90 days prior to Visit 1 (Screening) and throughout the study in either eye

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
Vehicle of DE-126 Ophthalmic Solution, high dose of DE-126 Ophthalmic SolutionVehicle of DE-126 Ophthalmic Solution dosed once daily for 6weeks, followed by high dose of DE-126 dosed once daily for 6 additional weeks	Drug	Placebo (Vehicle of DE-126) followed by high dose of DE-126
Topical ultra-low dose of DE-126 Ophthalmic SolutionTopical ultra-low dose of DE-126 Ophthalmic Solution dosed once daily for 12 weeks	Drug	Ultra-low dose 0.0005% DE-126
Topical low dose of DE-126 Ophthalmic SolutionTopical low dose of DE-126 Ophthalmic Solution dosed once daily for 12 weeks	Drug	Low dose 0.001% DE-126
Topical medium dose of DE-126 Ophthalmic SolutionTopical medium dose of DE-126 Ophthalmic Solution dosed once daily for 12 weeks	Drug	Medium dose 0.002% DE-126
Topical high dose of DE-126 Ophthalmic SolutionTopical high dose of DE-126 Ophthalmic Solution dosed once daily for 12 weeks	Drug	High dose 0.003% DE-126
0.005% Latanoprost Ophthalmic SolutionAlso: Xalatan®0.005% Latanoprost Ophthalmic Solution dosed once daily for 12 weeks	Drug	0.005% Latanoprost

Primary outcome

Intraocular Pressure in the Study Eye at Month 3
Time frame: 9:00, 13:00 and 17:00 at Month 3
Intraocular Pressure (IOP),the fluid pressure inside the eye was measured by the Goldmann applanation tonometer in millimeters mercury (mmHg) at 3 time-points throughout the day.

9 secondary outcomes

Intraocular Pressure in the Study Eye at Week 6
Time frame: 9:00, 13:00 and 17:00 at Week 6
Intraocular Pressure in the Study Eye at Week 1 and Week 2
Time frame: 9:00, 13:00 and 17:00 at Week 1 and Week 2
Mean Diurnal Intraocular Pressure in the Study Eye at Each Post-baseline Visit
Time frame: Week 1, Week 2, Week 6 and Month 3.
Change From Baseline (CFB) in Mean Diurnal Intraocular Pressure in the Study Eye at Each Post-baseline Visit
Time frame: Week 1, Week 2, Week 6 and Month 3.
Percent Change From Baseline (CFB) in Mean Diurnal Intraocular Pressure in the Study Eye at Each Post-baseline Visit
Time frame: Week 1, Week 2, Week 6 and Month 3.
Change From Baseline (CFB) in Intraocular Pressure in the Study Eye at Three Time Points at Each Post-baseline Visit
Time frame: 9:00, 13:00 and 17:00 at Week 1, Week 2, Week 6 and Month 3.
Percent Change From Baseline (CFB) in Intraocular Pressure in the Study Eye at Three Time Points at Each Post-baseline Visit
Time frame: 9:00, 13:00 and 17:00 at Week 1, Week 2, Week 6 and Month 3.
Percentage of Subjects With Mean Diurnal Intraocular Pressure Reduction From Baseline ≥ 20%, 25% and 30% in the Study Eye at Each Post-baseline Visit
Time frame: WeeK 1, Week 2, Week 6 and Month 3.
Percentage of Subjects With Mean Diurnal Intraocular Pressure ≤ 18 mmHg in the Study Eye at Each Post-baseline Visit
Time frame: Week 1, Week 2, Week 6 and Month 3.

Results and safety

Results posted to the registry on 23 Oct 2020, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Placebo (Vehicle of DE-126) Followed by High Dose of DE-126	22	20
0.005% Latanoprost	44	43
Ultra-low Dose 0.0005% DE-126	43	42
Low Dose 0.001% DE-126	43	43
Medium Dose 0.002% DE-126	44	43
High Dose 0.003% DE-126	45	42

Primary outcome: Intraocular Pressure in the Study Eye at Month 3

Time frame: 9:00, 13:00 and 17:00 at Month 3. Mean (Standard Deviation). Unit: mmHg

Measure	Placebo (Vehicle of DE-126) Followed by High Dose of DE-126 n = 22	0.005% Latanoprost n = 44	Ultra-low Dose 0.0005% DE-126 n = 43	Low Dose 0.001% DE-126 n = 43	Medium Dose 0.002% DE-126 n = 44	High Dose 0.003% DE-126 n = 45
9:00	18.8 (4.11)	18.1 (3.73)	19.7 (3.27)	19.2 (3.37)	17.6 (3.13)	19.3 (2.92)
13:00	17.6 (3.18)	17.3 (3.01)	18.5 (2.98)	18.1 (2.99)	17.4 (2.39)	18.7 (3.17)
17:00	17.8 (2.87)	17.2 (3.10)	18.3 (2.55)	17.8 (2.93)	16.7 (2.74)	17.9 (2.82)

Population analysed: The number of participants is reduced due to missing data.

9 secondary outcomes are reported in the full results.

Adverse events

Time frame: Reporting time frame is from Inform Consent to end of the study at Month3.. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Placebo P1	1 of 22 (4.5%)	2 of 22 (9.1%)	0 of 22
Placebo P2	0 of 20 (0%)	10 of 20 (50%)	0 of 20
0.005% Latanoprost	0 of 44 (0%)	18 of 44 (40.9%)	0 of 44
Ultra-low Dose DE-126	0 of 43 (0%)	13 of 43 (30.2%)	0 of 43
Low Dose DE-126	0 of 43 (0%)	12 of 43 (27.9%)	0 of 43
Medium Dose DE-126	0 of 44 (0%)	10 of 44 (22.7%)	0 of 44
High Dose of DE-126	0 of 45 (0%)	12 of 45 (26.7%)	0 of 45
High Dose of DE-126 Total	0 of 65 (0%)	22 of 65 (33.8%)	0 of 65
DE-126 Total	0 of 195 (0%)	57 of 195 (29.2%)	0 of 195

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 23 Oct 2020.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 35167779Wirta DL, Kuwayama Y, Lu F, Shao H, Odani-Kawabata N. Phase 2b, Randomized, 3-Month, Dose-Finding Study of Sepetaprost in Patients with Primary Open-Angle Glaucoma or Ocular Hypertension: The ANGEL Study. J Ocul Pharmacol Ther. 2022 Apr;38(3):240-251. doi: 10.1089/jop.2021.0077. Epub 2022 Feb 15.

Related trials for Open-angle Glaucoma, Ocular Hypertension

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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.

The record lists no contact. Use the official record to reach the sponsor.

17 sites in 2 countries: see every site and its status.

Questions about this trial

What is this clinical trial studying?

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 6 inclusion and 6 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 23 Oct 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 17 sites in United States, Japan. Whether a site is taking part right now should be confirmed with that site. See every site.

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 phase mean?

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 23 Oct 2020). 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?

Intraocular Pressure in the Study Eye at Month 3 (time frame: 9:00, 13:00 and 17:00 at Month 3). 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 NCT03216902, 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 23 Oct 2020.