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Clinical trial information and results are updated daily from ClinicalTrials.gov. The latest data update was conducted on 01/21/2021.

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

Clinicaltrials.gov identifier NCT03931317

Recruitment Status Recruiting

First Posted April 30, 2019

Last update posted June 9, 2020

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.

  • Condition or Disease:OAG - Open-Angle Glaucoma
    OHT - Ocular Hypertension
  • Intervention/Treatment: Drug: Latanoprostene bunod 0.024% QD
    Drug: Timolol maleate 0.5% BID
  • Phase: N/A
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).

Study Design
  • Study Type: Interventional
  • Estimated Enrollment: 40 participants
  • Allocation: Randomized
  • Intervention Model: Crossover Assignment
  • Masking: Single (Investigator)
  • Primary Purpose: Other
  • 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
  • Actual Study Start Date: December 2018
  • Estimated Primary Completion Date: December 2020
  • Estimated Study Completion Date: December 2020
Arms and interventions
Arm Intervention/treatment
Other: Latanoprostene bunod 0.024% QD
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
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.
Other: 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
Drug: Timolol maleate 0.5% BID
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.
Outcome Measures
  • Primary Outcome Measures: 1. retinal blood vessel density (peripapillary and macular) [ Time Frame: Through study completion, an average of 11 to 19 weeks ]
    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: 1. best-corrected visual acuity (BCVA) [ Time Frame: Through study completion, an average of 11 to 19 weeks ]
    The secondary efficacy endpoint for this study is change in best-corrected visual acuity (BCVA)
  • Other Outcome Measures: 1. Safety Endpoints: incidence of ocular and systemic adverse events (AEs) [ Time Frame: Through study completion, an average of 11 to 19 weeks ]
    The safety endpoint for this study is the incidence of ocular and systemic adverse events (AEs)
Eligibility Criteria
  • Ages Eligible for Study: 40 to 90 Years (Adult, Older Adult)
  • Sexes Eligible for Study: All
  • Accepts Healthy Volunteers: Yes
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).

Contacts and Locations
Contacts

Contact: Rafaella Penteado, MD 858-534-8824 rpenteado@ucsd.edu

Contact: Veronica Rubio 858-822-1896 vrubio@ucsd.edu

Locations

United States, California
UCSD Shiley Eye Institute
La Jolla

Sponsors and Collaborators

University of California, San Diego

Bausch & Lomb Incorporated

Investigators

Principal Investigator: Robert Weinreb, MD UCSD Shiley Eye Institute

More Information
  • Responsible Party: University of California, San Diego
  • ClinicalTrials.gov Identifier: NCT03931317 History of Changes
  • Other Study ID Numbers: 180658
  • First Posted: April 30, 2019 Key Record Dates
  • Last Update Posted: June 9, 2020
  • Last Verified: June 2020
  • Studies a U.S. FDA-regulated Drug Product: No
  • Studies a U.S. FDA-regulated Device Product: No
  • Product Manufactured in and Exported from the U.S.: Yes
  • Additional relevant MeSH terms: Glaucoma
    Glaucoma, Open-Angle
    Ocular Hypertension
    Hypertension