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
Overview
- Phase
- Phase 1
- Intervention
- H-1337 Placebo
- Conditions
- Glaucoma, Open-Angle
- Sponsor
- Allysta Pharmaceutical
- Enrollment
- 87
- Locations
- 1
- Primary Endpoint
- Intraocular Pressure (IOP)
- Status
- Completed
- Last Updated
- 3 years ago
Overview
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).
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.
Investigators
Eligibility Criteria
Inclusion Criteria
- •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.
- •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.
Exclusion Criteria
- •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.
Arms & Interventions
H-1337 Placebo
H-1337 Placebo
Intervention: H-1337 Placebo
H-1337 [1]
H-1337 \[1\]
Intervention: H-1337 [1]
H-1337 [2]
H-1337 \[2\]
Intervention: H-1337 [2]
H-1337 [3]
H-1337 \[3\]
Intervention: H-1337 [3]
Outcomes
Primary Outcomes
Intraocular Pressure (IOP)
Time Frame: Baseline and 28 days
Mean change in IOP from baseline on Day 28 (Time 0 + 4h)
Secondary Outcomes
- Number of Participants With Adverse Events(28 days)