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Glaucoma, Open-AnglePhase 1/2NCT03452033

H-1337 Ophthalmic Solution Phase 1/2

A Phase 1/2 study testing H-1337 [1], H-1337 [2] and H-1337 [3] in people with Glaucoma, Open-Angle, run by Allysta Pharmaceutical at 1 site 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

The study will evaluate the safety, tolerability, and preliminary efficacy of three concentrations of H-1337 and vehicle administered twice daily in a parallel group, double-masked design for 28 days of dosing in patients with elevated intraocular pressure (IOP). Read more about this study

Who is it for?
Ages 18 to 99 years
Conditions the study is for
Glaucoma, Open-Angle
What is being tested?
H-1337 [1], H-1337 [2] and H-1337 [3]
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
87 participants
Where
1 siteUnited States
Study dates
15 Mar 2018to 15 Aug 2018
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 to 99 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 18 years of age or older.
  • Diagnosis of bilateral primary open angle glaucoma or ocular hypertension.
  • One qualifying IOP criteria after washout:
  • Baseline (Day 0) at T0 (T0 = 8 am ± 30 min) IOP ≥ 23 mmHg in the study eye.
  • IOP criteria after washout ≤ 32 mmHg oculus uterque (OU) at all time points.
  • Best-corrected visual acuity (BCVA) in both eyes of 20/200 or better on Snellen, equivalent to + 1.0 log Mar.
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  • Able and willing to sign informed consent, follow study instructions and complete all study visits.
  • As applicable, must be willing to discontinue the use of all ocular hypotensive medication(s) in both eyes prior to receiving the study medication and for the entire course of the study.
  • Able to self-administer or have a caretaker administer study eye drops.

Who cannot join

  • Ophthalmic:
  • Exclude subjects with:
  • Closed or very narrow angles (Grade 0-1) (see Section 5, gonioscopy) or those the investigator judges as occludable and/or with evidence of peripheral anterior synechiae (PAS) ≥ 180 degrees by gonioscopy within 6 months prior to Screening Visit in either eye. (Patent laser iridotomy with Grade 1-2 angles is acceptable in either eye, providing the PAS criteria are still met).
  • Previous glaucoma intraocular surgery in either eye. Prior laser trabeculoplasty (ALT or SLT) in either eye is allowed if performed more than 6 months prior to Screening Visit.
  • Any non-glaucoma intraocular surgery within 3 months prior to Screening Visit in either eye.
  • Intraocular laser surgery such as laser capsulotomy, laser iridotomy, and/or retinal laser within 1 month prior to Screening Visit in either eye.
Show all 34Show fewer
  • Significant media opacity in either eye that would impede adequate posterior segment examination.
  • Contraindications to pupil dilation in either eye.
  • Other forms of glaucoma such as primary congenital, juvenile onset, chronic angle closure, and secondary glaucoma of any type including steroid-induced, inflammation-induced, or exfoliation glaucoma in either eye. Pigment dispersion syndrome/glaucoma is permitted in either eye.
  • Clinically significant corneal dystrophy, epithelial or endothelial disease, corneal irregularities or scarring that, in the investigator's judgment, would impede an accurate measurement of IOP or visualization of intraocular anatomy in the study eye.
  • History of refractive surgery in either eye (i.e., radial keratotomy, photorefractive keratectomy, LASIK).
  • History of corneal cross-linking procedure in either eye.
  • Unwillingness to be contact lens free during study participation.
  • Any history of uveitis, keratitis, or scleritis in either eye.
  • Any history of penetrating ocular trauma in either eye.
  • History within 3 months prior to Screening Visit of clinically significant moderate or severe chronic or active blepharitis, ocular dermatitis, or recent ocular conjunctivitis and/or ocular inflammation in either eye. Mild blepharitis, hyperemia (due to prostaglandin use) and/or blepharitis, and/or mild inactive seasonal allergic conjunctivitis and non-infective dermatitis are acceptable.
  • Corneal thickness < 480 or > 620 µm in the study eye. Pachymetry measurement within 6 months prior to Screening Visit is acceptable.
  • Advanced or severe glaucoma with progressive visual field loss and/or optic nerve changes in either eye that, in the investigator's best judgment, prevent safe withdrawal from treatment for the time periods required in this protocol.
  • Progressive retinal (including, but not limited to worsening dry age-related macular degeneration (AMD), presence of active wet AMD, or unstable diabetic retinopathy) or optic nerve disease in either eye from any cause other than glaucoma.
  • Any prior intravitreal steroid injection in either eye.
  • Sub-tenon's, sub-conjunctival or periocular steroid injections within the 6 months prior to Screening Visit in either eye.
  • Any use of ocular topical corticosteroids in either eye within 7 days, or chronic (as determined by the investigator) topical steroids within 28 days prior to Baseline and ensuing trial participation.
  • Known hypersensitivity to any component of the H-1337 formulation, including benzalkonium chloride, or to topical anesthetics or diagnostic drops used during the study.
  • Any ocular, condition that, in the investigator's judgment, could prevent the subject from safe participation the study.
  • Planned ocular surgery or intraocular injection procedure in either eye during study participation.
  • General/Systemic:
  • Participation in a clinical study with use of any investigational drug or treatment within 30 days prior to Baseline (Day 0).
  • Clinically significant abnormalities in: laboratory tests, physical examination, vital signs and/or ECG at Screening Visit. If in the investigator's judgment a subject with clinically significant abnormalities is appropriate for enrollment in the study, a discussion between the investigator and the Medical Monitor must occur and be documented prior to enrollment of this subject in the study.
  • Clinically significant systemic, psychiatric or psychological disease (for example, renal, hepatic, uncontrolled diabetes, uncontrolled blood pressure, autoimmune disorders, psychiatric disorders, endocrine disorders, or any other disorders) or dependency which, in the investigator's judgment, would be unsafe and interfere with interpretation of the study results or the subject's ability to comply with the study requirements.
  • Anticipated changes or initiation of medications which might affect IOP and/or systemic blood pressure within 7 days prior to Baseline/Day 0 (e.g., oral anti-hypertensives such as sympathomimetic agents, beta-adrenergic blocking agents, alpha agonists, alpha adrenergic blocking agents, calcium channel blockers, angiotensin converting enzyme inhibitors; [diuretics are allowed]), and 2 months prior to Baseline/Day 0 for corticosteroids (i.e., oral, nasal, topical [dermal, mucosal], and/or inhaled corticosteroids). If there are no further anticipated changes in medications that could affect IOP and/or systemic blood pressure, then once the subject is stable on their new dose of medication for the required time period, the subject may complete the Baseline Visit, assuming that all other screening requirements are met. Medications used on an adjustable or sliding scale based on testing results are allowed.
  • Known history of Hepatitis B + C, HIV+, or AIDS and/or inadequate venous access.
  • Women of childbearing potential who are pregnant, nursing, planning a pregnancy, or not using a medically acceptable form of birth control. An adult woman is considered to be of childbearing potential unless she is one year post-menopausal or three months post-surgical sterilization. All females of childbearing potential must have a negative serum pregnancy test result at Screening Visit and a negative urine and serum pregnancy test at Baseline (Day 0) prior to randomization in the study and must not intend to become pregnant during the study.
  • History of drug or alcohol abuse within the last 5 years.
  • Related to site study staff and/or site employees.

Trial locations and contacts

1 site in 1 country.

United States1 site

  • PRN

    Goose Creek, South Carolina, 29445

Other trials in United States

About this study

Official title: A Phase 1/2a Randomized, Double-masked, Placebo Controlled, Dose-ranging Study of the Safety and Efficacy of H-1337 in Subjects With Primary Open Angle Glaucoma (POAG) or Ocular Hypertension

The study will evaluate the safety, tolerability, and preliminary efficacy of three concentrations of H-1337 and vehicle administered twice daily in a parallel group, double-masked design for 28 days of dosing in patients with elevated intraocular pressure (IOP).

Read the detailed description

Study ALY337-201 will be a double-masked, randomized, placebo-controlled, dose-response study assessing the safety and ocular hypotensive efficacy of H-1337 ophthalmic solution in subjects with ocular hypertension (OHT) or open angle glaucoma.

During screening, subjects who meet the preliminary inclusion/exclusion criteria will discontinue use of their ocular hypotensive therapy during the washout period. The washout duration will be dependent on the subject's pre-study ocular hypotensive therapy. Starting on Day 0, those who continue to meet the inclusions/exclusion criteria and the diurnal IOP criteria will be randomized into one of the treatments arms and dosing will be initiated, continuing for 28 days.

Being tested
H-1337 Placebo, H-1337 [1], H-1337 [2], H-1337 [3]
Keywords
glaucoma
Medical subject headings
Glaucoma, Open-Angle, Glaucoma

What participants receive

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

  • H-1337 PlaceboDrug

    Also called Vehicle

    H-1337 Placebo Vehicle

  • H-1337 [1]Drug

    Also called H-1337 conc 1

    H-1337 Ophthalmic Solution Concentration 1

  • H-1337 [2]Drug

    Also called H-1337 conc 2

    H-1337 Ophthalmic Solution Concentration 2

  • H-1337 [3]Drug

    Also called H-1337 conc 3

    H-1337 Ophthalmic Solution Concentration 3

Study groups in NCT03452033
Study groupRoleWhat they receive
H-1337 PlaceboPlacebo comparatorH-1337 Placebo
Receives: Drug: H-1337 Placebo
H-1337 [1]ExperimentalH-1337 [1]
Receives: Drug: H-1337 [1]
H-1337 [2]ExperimentalH-1337 [2]
Receives: Drug: H-1337 [2]
H-1337 [3]ExperimentalH-1337 [3]
Receives: Drug: H-1337 [3]

What is being measured

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

  1. Intraocular Pressure (IOP)

    Mean change in IOP from baseline on Day 28 (Time 0 + 4h)

    Measured: Baseline and 28 days

Secondary outcomes (1)

  1. Number of Participants With Adverse Events

    Number of participants with treatment-emergent adverse events

    Measured: 28 days

Timeline

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

  1. First posted2 Mar 2018
  2. Study start15 Mar 2018
  3. Primary completion15 Aug 2018
  4. Study completion15 Aug 2018

Resources

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
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Model description
Double-masked, parallel
Masking
Double blind
Who is masked
Participant, Investigator
Enrolment
87 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03452033
Sponsor's protocol ID
ALY337-201
Status last verified
Jun 2022
First submitted
26 Feb 2018
Last updated
12 Jul 2022
Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No: No plan at current.

Publications

  • Hartman PJ, Cooke DL, Hsu HH, Stewart J, Sumi K, Yoshida Y, Hidaka H, Novack GD. Phase Ⅰ/Ⅱ, Double-Masked, Randomized, Vehicle-Controlled Study of H-1337 Ophthalmic Solution for Glaucoma and Ocular Hypertension. Ophthalmol Glaucoma. 2023 Mar-Apr;6(2):198-205. doi: 10.1016/j.ogla.2022.08.015. Epub 2022 Aug 31.

    PubMed 36055467

Questions about this trial

What is this clinical trial studying?

A Phase 1/2 study testing H-1337 [1], H-1337 [2] and H-1337 [3] in people with Glaucoma, Open-Angle, run by Allysta Pharmaceutical at 1 site in United States.

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 9 inclusion and 34 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 12 Jul 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site 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 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 2 Aug 2021). 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 (IOP) (time frame: Baseline and 28 days). 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 NCT03452033, 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 12 Jul 2022.

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