| Eligibility |
Inclusion Criteria:
- Subjects must be between 40 to 90 years of age, inclusive, on the date the Informed
Consent Form (ICF) is signed and with the capacity to provide voluntary informed
consent.
- Subjects must be able to read, understand, and provide written informed consent on the
Institutional Review Board (IRB) approved ICF. Only English speakers will be enrolled.
- Subjects who are able and willing to comply with all treatment and follow-up/study
procedures.
- Female subjects who are not of childbearing potential or female subjects who have a
negative urine pregnancy test result at Visit 1 (Screening) and Visit 3
(Randomization, Week 1).
- Females of childbearing potential, defined as a female who is fertile following
menarche, must have a negative serum pregnancy test at screening and agree to use an
acceptable method of contraception throughout their participation in the study.
Exclusion Criteria:
- Subjects participating in any drug or device clinical investigation within 30 days
prior to Visit 1 (Screening) for subjects requiring a washout period, or 30 days prior
to Visit 3 (Randomization, Week 1) for treatment naïve subjects.
- Subjects 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 currently taking systemic ß-adrenergic antagonists.
- Subjects with an anticipated need to initiate or modify medication (systemic or
topical) that is known to affect IOP (eg, a-adrenergic agonists, calcium channel
blockers, angiotensin converting enzyme [ACE] inhibitors, and angiotensin II receptor
blockers).
- Subjects with known hypersensitivity or contraindications to latanoprostene bunod or
any of the ingredients in the study drugs.
- Subjects with known hypersensitivity or contraindications to timolol maleate or other
-adrenergic receptor antagonists or any of the ingredients in the study drugs.
- Subjects who are expected to require treatment with ocular or systemic
corticosteroids.
- Subjects who are in need of any other topical or systemic treatment of OAG or OHT.
- Subjects 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 to and during
each study visit.
- Subjects with a central corneal thickness greater than 600 µm in either eye, measured
by pachymetry.
- Subjects with any condition that prevents reliable applanation tonometry (eg,
significant corneal surface abnormalities) in either eye.
- Subjects with advanced glaucoma.
- Subjects with any condition that prevents clear visualization of the fundus in either
eye.
- Subjects who are monocular.
- Subjects with previous or active corneal disease in either eye.
- Subjects with current or a history of severe dry eye in either eye.
- Subjects with active optic disc hemorrhage in either eye.
- Subjects with current or a history of central/branch retinal vein or artery occlusion
in either eye.
- Subjects with current or a history of macular edema in either eye.
- Subjects with very narrow angles (3 quadrants with less than Grade 2 according to
Shaffer's anterior chamber angle grading system) and subjects with angle closure,
congenital, and secondary glaucoma, and subjects with history of angle closure in
either eye.
- Subjects with a diagnosis of a clinically significant or progressive retinal disease
(eg, diabetic retinopathy, macular degeneration) in either eye.
- Subjects with any intraocular infection or inflammation in either eye within 3 months
prior to Visit 1 (Screening).
- Subjects with a history of ocular laser surgery in either eye within the 3 months
prior to Visit 1 (Screening).
- Subjects with a history of incisional ocular surgery or severe trauma in either eye
within 3 months prior to Visit 1 (Screening).
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