Ocular HypertensionPhase 2NCT04405245

Study to Assess the Efficacy, Safety and Tolerability of AKB-9778 Ophthalmic Solution as and Adjunct to Latanoprost in Patients With Ocular Hypertension or Open Angle Glaucoma

A Phase 2 study testing Latanoprost ophthalmic solution and AKB-9778 4% in people with Ocular Hypertension and Primary Open Angle Glaucoma, run by EyePoint Pharmaceuticals, Inc. at 21 sites in United States.

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

This is a phase 2, double masked, randomized, multi-center, parallel-group, 28-day study assessing the safety, tolerability and ocular hypotensive efficacy of AKB-9778 Ophthalmic Solution 4.0% administered once (AM) or twice (AM \& PM) daily when used as an adjunctive therapy to latanoprost ophthalmic solution 0.005%… Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Ocular Hypertension, Primary Open Angle Glaucoma
What is being tested?: Latanoprost ophthalmic solution and AKB-9778 4%
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 194 participants
Where: 21 sitesUnited States
Study dates: 6 Jun 2020to 5 Nov 2020
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

Diagnosis of OAG or OHT in each eye (OAG in one eye and OHT in the fellow eye is acceptable)
Must be receiving treatment with a stable regimen of topical prostaglandin eyedrop for a minimum of 2 weeks prior to the Screening Visit; may be taking one additional IOP lowering eyedrop
IOP of ≥ 18 mmHg and ≤ 27 mmHg in one eye or both eyes at Screening visit
Following 4 week washout period, IOP ≥ 24 mmHg and < 36 mmHg at 08:00 hour and IOP ≥ 22 mmHg and < 36 mmHg in both eyes at 10:00, 12:00 and 16:00 hours.

Who cannot join

Clinically significant ocular disease which might interfere with interpretation of the study efficacy endpoints or with safety assessments
Pseudoexfoliation or pigment dispersion component glaucoma
History of angle closure glaucoma, or narrow angles or with evidence of peripheral anterior synechiae (PAS) ≥ 180 degrees by gonioscopy within 6 months prior to Screening
Intraocular pressure ≥ 36 mmHg
Cup/disc ratio of > 0.8 in either eye
Severe visual field defect or significant defect (sensitivity of ≤ 10dB) within 10 degrees of fixation in either eye

Trial locations and contacts

21 sites in 1 country.

City, postcode or hospital

21 sites in 1 country

United States21 sites

Texan Eye / Keystone Research
Austin, Texas, 78731
Charlotte Eye, Ear, Nose & Throat Assoc. (CEENTA)
Charlotte, North Carolina, 28210
Apex Eye
Cincinnati, Ohio, 45242
Abrams Eye Center
Cleveland, Ohio, 44115
Scott & Christie and Assoc
Cranberry Township, Pennsylvania, 16066
United Medical Research Institute
Inglewood, California, 90301
Eye Care Specialists
Kingston, Pennsylvania, 18704
Shettle Eye Research
Largo, Florida, 33773
Total Eye Care
Memphis, Tennessee, 38119
North Valley Eye Medical Group
Mission Hills, California, 91345
Clayton Eye Clinical Research, LLC
Morrow, Georgia, 30260
Advancing Vision Research
Nashville, Tennessee, 37205
Eye Research Foundation
Newport Beach, California, 92663
North Bay Eye Associates
Petaluma, California, 94954
Kannarr Eye Care
Pittsburg, Kansas, 66762
North Valley Eye Medical Group
Rochester, New York, 14618
Coastal Research Associates
Roswell, Georgia, 30076
Heart of America Eye Care, P.A.
Shawnee Mission, Kansas, 66204
Tekwani Vision Center
St Louis, Missouri, 63128
Mark J. Weiss, MD, Inc.
Tulsa, Oklahoma, 74104
James D. Branch, MD Ophthalmology
Winston-Salem, North Carolina, 27101

Other trials in United States

About this study

Official title: Phase 2 Multi-Center, Double-Masked, Randomized, 28-Day Study to Assess the Efficacy, Safety and Tolerability of Single or Twice Daily Doses of AKB-9778 Ophthalmic Solution as an Adjunct to Latanoprost in Patients With Ocular Hypertension (OHT) or Open Angle Glaucoma (OAG)

Conditions: Ocular Hypertension, Primary Open Angle Glaucoma
Being tested: Latanoprost ophthalmic solution, AKB-9778 4%, Placebo
Medical subject headings: Ocular Hypertension, Glaucoma, Open-Angle

What participants receive

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

Latanoprost ophthalmic solutionDrug
Latanoprost opthalmic solution to be dosed once daily
AKB-9778 4%Drug
Razuprotafib opthalmic solution
PlaceboDrug
placebo for razuprotafib opthalmic solution

Study groups in NCT04405245
Study group	Role	What they receive
AKB-9778 4% QD + Latanoprost	Experimental	• AKB-9778 4% daily (AM) and placebo for ophthalmic solution daily (PM) plus latanoprost daily (PM) for 28 days Receives: Drug: Latanoprost ophthalmic solution; Drug: AKB-9778 4%
AKB-9778 4% BID + Latanoprost	Experimental	• AKB-9778 4% twice daily (AM \& PM) plus latanoprost daily (PM) for 28 days Receives: Drug: Latanoprost ophthalmic solution; Drug: AKB-9778 4%
Placebo Twice Daily + Latanoprost	Placebo comparator	• Placebo for AKB-9778 4% ophthalmic solution twice daily (AM \& PM) plus latanoprost daily (PM) for 28 days Receives: Drug: Latanoprost ophthalmic solution; Drug: Placebo

What is being measured

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

Change From Baseline in Intraocular Pressure at Day 28 (Study Eye)
Change from Baseline in Diurnal Mean IOP (mmHg) at Day 28 in the Study Eye -- ITT Population
Measured: Baseline to Day 28

Secondary outcomes (8)

Mean Change From Baseline in Diurnal Mean IOP at the Day 14 Visit (Study Eye)
Change from Baseline in Diurnal Mean IOP (mmHg) at Day 14 in the Study Eye -- ITT Population
Measured: Baseline to Day 14
Mean Change From Baseline in Diurnal Mean IOP on Days 14 and 28 (Both Eyes)
Mean change from baseline in diurnal mean IOP (measured in mmHg) at Day 14 and 28 in both eyes - ITT Population
Measured: Baseline to Day 14 and Baseline to Day 28
Observed Mean Diurnal Mean IOP on Days 14 and 28 (Both Eyes)
Mean of the Diurnal Mean IOP (mmHg) at Day 14 and Day 28 in both eyes -- ITT Population
Measured: Baseline to Day 14 and Baseline to Day 28
Mean Observed IOP at Each Time Point on Days 14 and 28
Mean observed IOP measured in mmHg at each time point on Days 14 and 28 (study eye) - ITT Population
Measured: Baseline to each timepoint on Day 14 and Baseline to each timepoint on Day 28
Mean Change From Baseline IOP at Each Time Point on Days 14 and 28
Change from Baseline in Mean IOP (mmHg) at Each Time Point on Day 14 and Day 28 in the Study Eyes -- ITT Population
Measured: Baseline to each timepoint on Day 14 and Baseline to each timepoint on Day 28
Mean Percent Change From Diurnally Adjusted Baseline IOP at Each Time Point on Days 14 and 28
Percent Change from Baseline IOP (mmHg) at Each Time Point on Day 14 and Day 28 in the Study Eyes -- ITT Population
Measured: Baseline to each timepoint on Day 14 and Baseline to each timepoint on Day 28
Mean Percent Change From Baseline in Diurnal Mean IOP on Days 14 and 28
Percent Change from Baseline in Diurnal Mean IOP (mmHg) at Day 14 and Day 28 in the Study Eye -- ITT Population
Measured: Baseline to Day 14 and Baseline to Day 28
Percentages of Subjects Achieving Pre-Specified Mean, Mean Change, and Percent Mean Change in Diurnal Mean IOP Levels
Percentages of Subjects Achieving Pre-Specified Mean, Mean Change, and Percent Mean Change in Diurnal Mean IOP Levels in Study Eye -- ITT Population
Measured: Baseline to Day 28

Timeline

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

6 Jun 20205 Nov 2020

First posted28 May 2020
Study start6 Jun 2020
Primary completion5 Nov 2020
Study completion5 Nov 2020

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.
Other trials for 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: Triple blind
Who is masked: Participant, Care provider, Investigator
Enrolment: 194 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT04405245
Sponsor's protocol ID: AKB-9778-CI-OS-2001
Status last verified: May 2023
First submitted: 23 May 2020
Last updated: 25 May 2023
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: Yes
FDA-regulated device: No
Individual data sharing: No

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 Ocular Hypertension trials

Study at a glance

From the registry record, last updated by the sponsor on 25 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Phase 2 Multi-Center, Double-Masked, Randomized, 28-Day Study to Assess the Efficacy, Safety and Tolerability of Single or Twice Daily Doses of AKB-9778 Ophthalmic Solution as an Adjunct to Latanoprost in Patients With Ocular Hypertension (OHT) or Open Angle Glaucoma (OAG)
ClinicalTrials.gov ID: NCT04405245
Acronym / sponsor ID: AKB-9778-CI-OS-2001
Conditions: Ocular Hypertension, Primary Open Angle Glaucoma
Phase: Phase 2
Study type: Interventional
Recruitment status: Completed
Enrolment: 194 participants (actual)
Lead sponsor: EyePoint Pharmaceuticals, Inc.Industry (pharma, biotech, devices)
Study start: 6 Jun 2020 (actual)
Primary completion: 5 Nov 2020 (actual)
Study completion: 5 Nov 2020 (actual)
First posted: 28 May 2020 (actual)
Results: Posted 25 May 2023

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: Triple blind (participant, care provider, investigator)
Number of arms: 3

Arm	Type	Receives
AKB-9778 4% QD + Latanoprost	Experimental	Drug: Latanoprost ophthalmic solution, Drug: AKB-9778 4%• AKB-9778 4% daily (AM) and placebo for ophthalmic solution daily (PM) plus latanoprost daily (PM) for 28 days
AKB-9778 4% BID + Latanoprost	Experimental	Drug: Latanoprost ophthalmic solution, Drug: AKB-9778 4%• AKB-9778 4% twice daily (AM \& PM) plus latanoprost daily (PM) for 28 days
Placebo Twice Daily + Latanoprost	Placebo comparator	Drug: Latanoprost ophthalmic solution, Drug: Placebo• Placebo for AKB-9778 4% ophthalmic solution twice daily (AM \& PM) plus latanoprost daily (PM) for 28 days

Who may qualify

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

Key inclusion criteria (4 listed)

Diagnosis of OAG or OHT in each eye (OAG in one eye and OHT in the fellow eye is acceptable)
Must be receiving treatment with a stable regimen of topical prostaglandin eyedrop for a minimum of 2 weeks prior to the Screening Visit; may be taking one additional IOP lowering eyedrop
IOP of ≥ 18 mmHg and ≤ 27 mmHg in one eye or both eyes at Screening visit
Following 4 week washout period, IOP ≥ 24 mmHg and < 36 mmHg at 08:00 hour and IOP ≥ 22 mmHg and < 36 mmHg in both eyes at 10:00, 12:00 and 16:00 hours.

Key exclusion criteria (6 listed)

Clinically significant ocular disease which might interfere with interpretation of the study efficacy endpoints or with safety assessments
Pseudoexfoliation or pigment dispersion component glaucoma
History of angle closure glaucoma, or narrow angles or with evidence of peripheral anterior synechiae (PAS) ≥ 180 degrees by gonioscopy within 6 months prior to Screening
Intraocular pressure ≥ 36 mmHg
Cup/disc ratio of > 0.8 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
Latanoprost ophthalmic solutionLatanoprost opthalmic solution to be dosed once daily	Drug	AKB-9778 4% BID + Latanoprost, AKB-9778 4% QD + Latanoprost, Placebo Twice Daily + Latanoprost
AKB-9778 4%Razuprotafib opthalmic solution	Drug	AKB-9778 4% BID + Latanoprost, AKB-9778 4% QD + Latanoprost
Placeboplacebo for razuprotafib opthalmic solution	Drug	Placebo Twice Daily + Latanoprost

Primary outcome

Change From Baseline in Intraocular Pressure at Day 28 (Study Eye)
Time frame: Baseline to Day 28
Change from Baseline in Diurnal Mean IOP (mmHg) at Day 28 in the Study Eye -- ITT Population

8 secondary outcomes

Mean Change From Baseline in Diurnal Mean IOP at the Day 14 Visit (Study Eye)
Time frame: Baseline to Day 14
Mean Change From Baseline in Diurnal Mean IOP on Days 14 and 28 (Both Eyes)
Time frame: Baseline to Day 14 and Baseline to Day 28
Observed Mean Diurnal Mean IOP on Days 14 and 28 (Both Eyes)
Time frame: Baseline to Day 14 and Baseline to Day 28
Mean Observed IOP at Each Time Point on Days 14 and 28
Time frame: Baseline to each timepoint on Day 14 and Baseline to each timepoint on Day 28
Mean Change From Baseline IOP at Each Time Point on Days 14 and 28
Time frame: Baseline to each timepoint on Day 14 and Baseline to each timepoint on Day 28
Mean Percent Change From Diurnally Adjusted Baseline IOP at Each Time Point on Days 14 and 28
Time frame: Baseline to each timepoint on Day 14 and Baseline to each timepoint on Day 28
Mean Percent Change From Baseline in Diurnal Mean IOP on Days 14 and 28
Time frame: Baseline to Day 14 and Baseline to Day 28
Percentages of Subjects Achieving Pre-Specified Mean, Mean Change, and Percent Mean Change in Diurnal Mean IOP Levels
Time frame: Baseline to Day 28

Results and safety

Results posted to the registry on 25 May 2023, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
AKB-9778 4% QD + Latanoprost	65	65
AKB-9778 4% BID + Latanoprost	65	64
Placebo BID + Latanoprost	64	64

Primary outcome: Change From Baseline in Intraocular Pressure at Day 28 (Study Eye)

Time frame: Baseline to Day 28. Least squares mean (Standard Error). Unit: mmHg

Measure	AKB-9778 4% QD + Latanoprost n = 65	AKB-9778 4% BID + Latanoprost n = 65	Placebo Twice Daily + Latanoprost n = 64
Value	-6.95 (0.258)	-7.95 (0.257)	-7.04 (0.259)

AKB-9778 4% QD + Latanoprost: Mean Difference (Final Values): 0.09 (95% CI -0.63 to 0.81), p = 0.8070, ANCOVA
AKB-9778 4% BID + Latanoprost: Mean Difference (Final Values): -0.92 (95% CI -1.64 to -0.20), p = 0.0130, ANCOVA

Population analysed: The ITT population will include all randomized subjects who have received at least one dose of study medication. This population will be the primary population for efficacy analyses and will be used to summarize all efficacy variables and will summarize subjects as randomized.

8 secondary outcomes are reported in the full results.

Adverse events

Time frame: Treatment-emergent adverse events were collected for the entire duration of the study, which was approximately 11 weeks.. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
AKB-9778 4% QD + Latanoprost	0 of 65 (0%)	30 of 65 (46.2%)	0 of 65
AKB-9778 4% BID + Latanoprost	0 of 65 (0%)	43 of 65 (66.2%)	0 of 65
Placebo BID + Latanoprost	0 of 64 (0%)	19 of 64 (29.7%)	0 of 64

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 25 May 2023.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Individual participant dataSharing planned: No

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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.

21 sites in 1 country: 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 4 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 25 May 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 21 sites in United States. 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 25 May 2023). 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?

Change From Baseline in Intraocular Pressure at Day 28 (Study Eye) (time frame: Baseline to Day 28). 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 NCT04405245.

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 25 May 2023.