NCT03452033

H-1337 Ophthalmic Solution Phase 1/2

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

• Status: Completed
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 87 (actual)
• Sponsor: Allysta Pharmaceutical · Industry
• Sex: All
• Age: 18 Years – 99 Years
• Healthy volunteers: Not accepted

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).

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.

Conditions

• Glaucoma, Open-Angle

Interventions

Type	Name	Description
DRUG	H-1337 Placebo	H-1337 Placebo Vehicle
DRUG	H-1337 [1]	H-1337 Ophthalmic Solution Concentration 1
DRUG	H-1337 [2]	H-1337 Ophthalmic Solution Concentration 2
DRUG	H-1337 [3]	H-1337 Ophthalmic Solution Concentration 3

Timeline

• Start date: 2018-03-15
• Primary completion: 2018-08-15
• Completion: 2018-08-15
• First posted: 2018-03-02
• Last updated: 2022-07-12
• Results posted: 2021-08-02

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study