| Eligibility |
Inclusion Criteria:
1. 18 years of age or older.
2. Diagnosis of bilateral primary open angle glaucoma or ocular hypertension.
3. One qualifying IOP criteria after washout:
• Baseline (Day 0) at T0 (T0 = 8 am ± 30 min) IOP = 23 mmHg in the study eye.
4. IOP criteria after washout = 32 mmHg oculus uterque (OU) at all time points.
5. Best-corrected visual acuity (BCVA) in both eyes of 20/200 or better on Snellen,
equivalent to + 1.0 log Mar.
6. Able and willing to sign informed consent, follow study instructions and complete all
study visits.
7. 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.
8. Able to self-administer or have a caretaker administer study eye drops.
Exclusion Criteria:
Ophthalmic:
Exclude subjects with:
1. 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).
2. 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.
3. Any non-glaucoma intraocular surgery within 3 months prior to Screening Visit in
either eye.
4. Intraocular laser surgery such as laser capsulotomy, laser iridotomy, and/or retinal
laser within 1 month prior to Screening Visit in either eye.
5. Significant media opacity in either eye that would impede adequate posterior segment
examination.
6. Contraindications to pupil dilation in either eye.
7. 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.
8. 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.
9. History of refractive surgery in either eye (i.e., radial keratotomy, photorefractive
keratectomy, LASIK).
10. History of corneal cross-linking procedure in either eye.
11. Unwillingness to be contact lens free during study participation.
12. Any history of uveitis, keratitis, or scleritis in either eye.
13. Any history of penetrating ocular trauma in either eye.
14. 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.
15. Corneal thickness < 480 or > 620 µm in the study eye. Pachymetry measurement within 6
months prior to Screening Visit is acceptable.
16. 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.
17. 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.
18. Any prior intravitreal steroid injection in either eye.
19. Sub-tenon's, sub-conjunctival or periocular steroid injections within the 6 months
prior to Screening Visit in either eye.
20. 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.
21. Known hypersensitivity to any component of the H-1337 formulation, including
benzalkonium chloride, or to topical anesthetics or diagnostic drops used during the
study.
22. Any ocular, condition that, in the investigator's judgment, could prevent the subject
from safe participation the study.
23. Planned ocular surgery or intraocular injection procedure in either eye during study
participation.
General/Systemic:
24. Participation in a clinical study with use of any investigational drug or treatment
within 30 days prior to Baseline (Day 0).
25. 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.
26. 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.
27. 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.
28. Known history of Hepatitis B + C, HIV+, or AIDS and/or inadequate venous access.
29. 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.
30. History of drug or alcohol abuse within the last 5 years.
31. Related to site study staff and/or site employees.
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