NCT03452033

H-1337 Ophthalmic Solution Phase 1/2

Completed Phase 1, PHASE2 Results posted Last updated 12 July 2022

What this trial tests

Phase 1, PHASE2 trial testing H-1337 Placebo in Glaucoma, Open-Angle in 87 participants. Completed in 15 August 2018.

Timeline

15 March 2018

Primary endpoint
15 August 2018

15 August 2018

Quick facts

Lead sponsor	Allysta Pharmaceutical
Phase	Phase 1, PHASE2
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	double
Primary purpose	treatment
Enrollment	87
Start date	15 March 2018
Primary completion	15 August 2018
Estimated completion	15 August 2018
Sites	1 location across United States

Drugs / interventions tested

• H-1337 Placebo — full drug profile →
• H-1337 [1] — full drug profile →
• H-1337 [2] — full drug profile →
• H-1337 [3] — full drug profile →

Conditions studied

• Glaucoma, Open-Angle — all drugs for Glaucoma, Open-Angle →

Sponsor

Allysta Pharmaceutical — full company profile →

Who can join

Adults 18 to 99, any sex, with Glaucoma, Open-Angle. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Intraocular Pressure (IOP) Primary · Baseline and 28 days

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

Group	Value	95% CI
H-1337 0.06%	-4.45	± 3.801
H-1337 0.2%	-5.16	± 3.114
H-1337 0.6%	-4.93	± 3.110
Vehicle	-0.39	± 2.355

Number of Participants With Adverse Events Secondary · 28 days

Number of participants with treatment-emergent adverse events

Group	Value	95% CI
H-1337 0.06%	9
H-1337 0.2%	9
H-1337 0.6%	14
Vehicle	4

Adverse events — posted to ClinicalTrials.gov

Time frame: 28 days. Reporting threshold: 5%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

H-1337 0.06%

Serious: 0/21 (0%)

Deaths: 0/21

H-1337 0.2%

Serious: 0/22 (0%)

Deaths: 0/22

H-1337 0.6%

Serious: 0/22 (0%)

Deaths: 0/22

Vehicle

Serious: 0/22 (0%)

Deaths: 0/22

Other adverse events (2 terms — click to expand)

Reaction	System	H-1337 0.06%	H-1337 0.2%	H-1337 0.6%	Vehicle
General disorders and administration site conditiions	General disorders	—	—	—	—
Eye disorders	Eye disorders	—	—	—	—

Data from ClinicalTrials.gov NCT03452033 adverse events section.

Sponsor's own description

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).

Publications & conference data

2 peer-reviewed publications reference this trial (live from Europe PMC):

1. Glaucoma Clinical Research: Trends in Treatment Strategies and Drug Development.
   Storgaard L, Tran TL, Freiberg JC, Hauser AS, et al · · 2021 · cited 50× · PMID 34589504 · DOI 10.3389/fmed.2021.733080
2. Phase Ⅰ/Ⅱ, Double-Masked, Randomized, Vehicle-Controlled Study of H-1337 Ophthalmic Solution for Glaucoma and Ocular Hypertension.
   Hartman PJ, Cooke DL, Hsu HH, Stewart J, et al · · 2023 · cited 3× · PMID 36055467 · DOI 10.1016/j.ogla.2022.08.015