Study Comparing the Effects of Latanoprostene Bunod and Timolol on Retinal Blood Vessel Density and Visual Acuity

• Status: Completed
• Trial end date: 2021-05-20
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this research study is to compare the effect of Latanoprostene Bunod and Timolol on eye pressure and blood vessels of the back of the eye.

• Phase: N/A
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: University of California, San Diego
• Collaborator: Bausch & Lomb Incorporated
• Treatments: Maleic acid; Timolol

Criteria

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 β-adrenergic antagonists.

• Subjects with an anticipated need to initiate or modify medication (systemic or topical) that is known to affect IOP (eg, α-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).