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

NCT03931317 | Completed

• 1 other identifier: 180658
• Study Type: interventional
• Target: 70
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

OAG - Open-Angle Glaucoma; OHT - Ocular Hypertension

Outcome Measures

Primary Outcomes (1)

• retinal blood vessel density (peripapillary and macular)

  The primary efficacy endpoint for this study is the change in retinal blood vessel density (peripapillary and macular) between treatment groups after 4 weeks of treatment (Visit 4 \[Week 5\] and Visit 6 \[Week 11\]).

  Through study completion, an average of 11 to 19 weeks

Secondary Outcomes (1)

• best-corrected visual acuity (BCVA)

  Through study completion, an average of 11 to 19 weeks

Other Outcomes (1)

• Safety Endpoints: incidence of ocular and systemic adverse events (AEs)

  Through study completion, an average of 11 to 19 weeks

Study Arms (2)

Latanoprostene bunod 0.024% QD

OTHER

4 weeks of Latanoprostene bunod 0.024% QD, then a 2 Week washout, followed by 4 weeks of Timolol maleate 0.5% BID

Drug: Latanoprostene bunod 0.024% QD

Timolol maleate 0.5% BID

OTHER

4 weeks of Timolol maleate 0.5% BID, then a 2 Week washout, followed by 4 weeks of Latanoprostene bunod 0.024% QD

Drug: Timolol maleate 0.5% BID

Interventions

Latanoprostene bunod 0.024% QD DRUG

This is a randomized, single-center, investigator-masked, 2-period, 8-week treatment study with washout and crossover between treatment periods. There will be 2 treatments in this study: latanoprostene bunod 0.024% QD and timolol maleate 0.5% BID.

Also known as: Vyzulta

Latanoprostene bunod 0.024% QD

Timolol maleate 0.5% BID DRUG

This is a randomized, single-center, investigator-masked, 2-period, 8-week treatment study with washout and crossover between treatment periods. There will be 2 treatments in this study: latanoprostene bunod 0.024% QD and timolol maleate 0.5% BID.

Also known as: Timoptic

Timolol maleate 0.5% BID

Eligibility Criteria

• Age: 40 Years - 90 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of California, San Diego: lead
• Bausch & Lomb Incorporated: collaborator

Study Sites (1)

UCSD Shiley Eye Institute

La Jolla, California, 92093, United States

Location

MeSH Terms

Conditions

Glaucoma, Open-Angle; Ocular Hypertension

Interventions

BOL 303259-X; Timolol; BID protein, human

Condition Hierarchy (Ancestors)

Glaucoma; Eye Diseases

Intervention Hierarchy (Ancestors)

Propanolamines; Amino Alcohols; Alcohols; Organic Chemicals; Propanols; Amines; Thiadiazoles; Thiazoles; Sulfur Compounds; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Morpholines; Oxazines

Study Officials

• Robert Weinreb, MD

  UCSD Shiley Eye Institute

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: OTHER
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Distinguished Professor and Chair, Ophthalmology

Study Record Dates

• First Submitted: March 31, 2019
• First Posted: April 30, 2019
• Study Start: December 3, 2018
• Primary Completion: May 20, 2021
• Study Completion: March 1, 2023
• Last Updated: August 29, 2023

Record last verified: 2023-08

Locations

US (1)