H-1337 Ophthalmic Solution Phase 1/2

NCT03452033 | Completed Phase 1 Results FDA Drug

• 1 other identifier: ALY337-201
• Study Type: interventional
• Target: 87
• Locations: 1 country
• Sites: 1

Brief 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).

Conditions

Glaucoma, Open-Angle

Keywords

glaucoma

Outcome Measures

Primary Outcomes (1)

• Intraocular Pressure (IOP)

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

  Baseline and 28 days

Secondary Outcomes (1)

• Number of Participants With Adverse Events

  28 days

Study Arms (4)

H-1337 Placebo

PLACEBO COMPARATOR

H-1337 Placebo

Drug: H-1337 Placebo

H-1337 [1]

EXPERIMENTAL

H-1337 \[1\]

Drug: H-1337 [1]

H-1337 [2]

EXPERIMENTAL

H-1337 \[2\]

Drug: H-1337 [2]

H-1337 [3]

EXPERIMENTAL

H-1337 \[3\]

Drug: H-1337 [3]

Interventions

H-1337 Placebo DRUG

H-1337 Placebo Vehicle

Also known as: Vehicle

H-1337 Placebo

H-1337 [1] DRUG

H-1337 Ophthalmic Solution Concentration 1

Also known as: H-1337 conc 1

H-1337 [1]

H-1337 [2] DRUG

H-1337 Ophthalmic Solution Concentration 2

Also known as: H-1337 conc 2

H-1337 [2]

H-1337 [3] DRUG

H-1337 Ophthalmic Solution Concentration 3

Also known as: H-1337 conc 3

H-1337 [3]

Eligibility Criteria

• Age: 18 Years - 99 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.
• 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.

You may not qualify if:

• 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.
• 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.

Sponsors & Collaborators

• Allysta Pharmaceutical: lead

Study Sites (1)

PRN

Goose Creek, South Carolina, 29445, United States

Location

Related Publications (1)

• 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.

  PMID: 36055467 DERIVED

MeSH Terms

Conditions

Glaucoma, Open-Angle; Glaucoma

Condition Hierarchy (Ancestors)

Ocular Hypertension; Eye Diseases

Results Point of Contact

• Title: Shigenobu Nakazora
• Organization: D. Western Therapeutics Institute

shinakazora@dwti.co.jp

+81-52-218-8785

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Masking Details: Double-masked containers
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Double-masked, parallel

Study Record Dates

• First Submitted: February 26, 2018
• First Posted: March 2, 2018
• Study Start: March 15, 2018
• Primary Completion: August 15, 2018
• Study Completion: August 15, 2018
• Last Updated: July 12, 2022
• Results First Posted: August 2, 2021

Record last verified: 2022-06

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)