Clinical Trials

General Inclusion Criteria:

• Subjects must be ≥18 years of age, must be able to read, understand, and provide written informed consent on the Institutional Review Board (IRB)‑approved ICF and are able and willing to comply with all treatment and follow-up/study procedures.
• Females of childbearing potential must have a negative urine pregnancy test result at the screening examination and must agree to use an acceptable method of contraception throughout their participation in the study.

Ocular Inclusion Criteria:

• Subjects must have a diagnosis of OHT in both eyes (IOP ≥ 22 mmHg prior to starting treatment with IOP-lowering medication) without evidence of glaucomatous optic neuropathy or visual field loss and have been receiving IOP-lowering medication for ≥ 3 months prior to Visit 1.
• Subjects must undergo a washout of any existing ocular hypotensive medications in order to determine eligibility. Washout period will vary with the class of medication used (2-6 weeks).
• Subjects must meet the following IOP requirements at Visit 3 (Eligibility Visit at End of Washout):
  • Intraocular pressure ≥ 22 mmHg and ≤ 32 mmHg in both eyes;
  • An increase in IOP of ≥ 20% over the screening visit (Visit 1) IOP in both eyes;
  • A difference in IOP between eyes ≤ 4 mmHg.
• Subjects must have a BCVA in each eye of 20/50 (LogMAR +0.4) or better.

General Exclusion Criteria:

• Subjects participating in any drug or device clinical investigation within 30 days prior to Visit 1 (Screening) or who anticipate participating in any other drug or device clinical investigation within the duration of this study. 
• Subjects with a history or presence of chronic generalized systemic disease that the Investigator feels might increase the risk to the subject or confound the results of the study.
• Female subjects who are pregnant or breastfeeding.
• Subjects with Body Mass Index (BMI) ≥ 40.0. Subjects with BMI 35.0-39.9 may be excluded at the discretion of the PI.

Ocular Exclusion Criteria:

Diseases

• Participants who are unable to discontinue contact lens use during and for 15 minutes following instillation of study drug and for 24 hours before check-in and during each study visit.
• Participants with a central corneal thickness less than 480 μm or greater than 600 micrometer (μm) in either eye.
• Participants with any condition that prevents reliable applanation tonometry (for example, significant corneal surface abnormalities) in either eye. 
• Participants who are monocular. 
• Participants with ocular conditions, which, in the opinion of the Investigator, will impact the study measurements, such as:
  • Active optic disc hemorrhage in either eye;
  • Current or a history of central/branch retinal vein or artery occlusion in either eye;
  • Current or a history of macular edema in either eye;
  • Very narrow angles (3 quadrants with less than Grade 2 according to Shaffer's anterior chamber angle grading system) and participants with angle closure, congenital, and secondary glaucoma, and with history of angle closure in either eye;
  • Diagnosis of a clinically significant or progressive retinal disease (for example, diabetic retinopathy, exudative or severe non-exudative macular degeneration) in either eye.
• Participants with any intraocular infection or inflammation in either eye within 3 months prior to Visit 1 (Screening). 
• Myopia greater than -4.00 diopter (D), or hyperopia greater than +2.000 Surgery.
• Participants with a history of ocular laser surgery in either eye within the 3 months (90 days) prior to Visit 1 (Screening).
• Participants with a history of laser trabeculoplasty, cyclophotocoagulation or glaucoma surgical procedures at any time prior to Visit 1 (Screening). 
• Participants with a history of incisional ocular surgery other than routine uncomplicated cataract surgery or severe trauma in either eye within the 3 months (90 days) prior to Visit 1 (Screening).

Eligibility last updated 2/28/22. Questions regarding updates should be directed to the study team contact.