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

Primary Purpose

OAG - Open-Angle Glaucoma, OHT - Ocular Hypertension

Status

Completed

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

Latanoprostene bunod 0.024% QD

Timolol maleate 0.5% BID

About this trial

This is an interventional other trial for OAG - Open-Angle Glaucoma

Eligibility Criteria

40 Years - 90 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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).

Sites / Locations

UCSD Shiley Eye Institute

Arms of the Study

Arm 1

Arm 2

Arm Type

Other

Arm Label

Latanoprostene bunod 0.024% QD

Timolol maleate 0.5% BID

Arm Description

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

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

Outcomes

Primary Outcome Measures

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]).

Secondary Outcome Measures

best-corrected visual acuity (BCVA)

The secondary efficacy endpoint for this study is change in best-corrected visual acuity (BCVA)

Full Information

NCT ID

NCT03931317

First Posted

March 31, 2019

Last Updated

August 26, 2023

Sponsor

University of California, San Diego

Collaborators

Bausch & Lomb Incorporated

1. Study Identification

Unique Protocol Identification Number

NCT03931317

Brief Title

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

Official Title

A Randomized, Single Center, Masked, Crossover Study Comparing the Effects of Latanoprostene Bunod and Timolol on Retinal Blood Vessel Density and Visual Acuity in Patients With Ocular Hypertension or Primary Open Angle Glaucoma

Study Type

Interventional

2. Study Status

Record Verification Date

August 2023

Overall Recruitment Status

Completed

Study Start Date

December 3, 2018 (Actual)

Primary Completion Date

May 20, 2021 (Actual)

Study Completion Date

March 1, 2023 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

University of California, San Diego

Collaborators

Bausch & Lomb Incorporated

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Product Manufactured in and Exported from the U.S.

Data Monitoring Committee

5. Study Description

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.

Detailed Description

The primary objective of this clinical investigation is to compare the difference in change in retinal blood vessel density (peripapillary and macular) between latanoprostene bunod (LBN) ophthalmic solution 0.024% dosed once daily (QD) and timolol maleate 0.5% dosed twice daily (BID) in subjects with OAG or OHT and in normal subjects. Primary Efficacy Endpoint 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]). Secondary Efficacy Endpoints The secondary efficacy endpoint for this study is change in best-corrected visual acuity (BCVA). Safety Endpoints The safety endpoint for this study is the incidence of ocular and systemic adverse events (AEs).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

OAG - Open-Angle Glaucoma, OHT - Ocular Hypertension

7. Study Design

Primary Purpose

Other

Study Phase

Not Applicable

Interventional Study Model

Crossover Assignment

Masking

Investigator

Allocation

Randomized

Enrollment

70 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Latanoprostene bunod 0.024% QD

Arm Type

Other

Arm Description

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

Arm Title

Timolol maleate 0.5% BID

Arm Type

Other

Arm Description

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

Intervention Type

Drug

Intervention Name(s)

Latanoprostene bunod 0.024% QD

Other Intervention Name(s)

Vyzulta

Intervention Description

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.

Intervention Type

Drug

Intervention Name(s)

Timolol maleate 0.5% BID

Other Intervention Name(s)

Timoptic

Intervention Description

Primary Outcome Measure Information:

Title

retinal blood vessel density (peripapillary and macular)

Description

Time Frame

Through study completion, an average of 11 to 19 weeks

Secondary Outcome Measure Information:

Title

best-corrected visual acuity (BCVA)

Description

The secondary efficacy endpoint for this study is change in best-corrected visual acuity (BCVA)

Time Frame

Through study completion, an average of 11 to 19 weeks

Other Pre-specified Outcome Measures:

Title

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

Description

The safety endpoint for this study is the incidence of ocular and systemic adverse events (AEs)

Time Frame

Through study completion, an average of 11 to 19 weeks

10. Eligibility

Sex

All

Minimum Age & Unit of Time

40 Years

Maximum Age & Unit of Time

90 Years

Accepts Healthy Volunteers

Eligibility 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).

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Robert Weinreb, MD

Organizational Affiliation

UCSD Shiley Eye Institute

Official's Role

Principal Investigator

Facility Information:

Facility Name

UCSD Shiley Eye Institute

City

La Jolla

State/Province

California

ZIP/Postal Code

92093

Country

United States

12. IPD Sharing Statement

Learn more about this trial

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

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