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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03931317
Recruitment Status : Recruiting
First Posted : April 30, 2019
Last Update Posted : June 9, 2020
Sponsor:
Collaborator:
Bausch & Lomb Incorporated
Information provided by (Responsible Party):
Robert Weinreb, University of California, San Diego

Tracking Information
First Submitted Date  ICMJE March 31, 2019
First Posted Date  ICMJE April 30, 2019
Last Update Posted Date June 9, 2020
Actual Study Start Date  ICMJE December 3, 2018
Estimated Primary Completion Date December 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: April 26, 2019)
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]).
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: April 26, 2019)
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)
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures
 (submitted: April 26, 2019)
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)
Original Other Pre-specified Outcome Measures Same as current
 
Descriptive Information
Brief Title  ICMJE Study Comparing the Effects of Latanoprostene Bunod and Timolol on Retinal Blood Vessel Density and Visual Acuity
Official Title  ICMJE 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
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).

Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Single (Investigator)
Primary Purpose: Other
Condition  ICMJE
  • OAG - Open-Angle Glaucoma
  • OHT - Ocular Hypertension
Intervention  ICMJE
  • 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 Name: Vyzulta
  • 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.
    Other Name: Timoptic
Study Arms  ICMJE
  • 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
    Intervention: Drug: Latanoprostene bunod 0.024% QD
  • 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
    Intervention: Drug: Timolol maleate 0.5% BID
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: April 26, 2019)
40
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE December 2020
Estimated Primary Completion Date December 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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).
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 40 Years to 90 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE
Contact: Rafaella Penteado, MD 858-534-8824 rpenteado@ucsd.edu
Contact: Veronica Rubio 858-822-1896 vrubio@ucsd.edu
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03931317
Other Study ID Numbers  ICMJE 180658
Has Data Monitoring Committee No
U.S. FDA-regulated Product
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.: No
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Robert Weinreb, University of California, San Diego
Study Sponsor  ICMJE University of California, San Diego
Collaborators  ICMJE Bausch & Lomb Incorporated
Investigators  ICMJE
Principal Investigator: Robert Weinreb, MD UCSD Shiley Eye Institute
PRS Account University of California, San Diego
Verification Date June 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP