OAG - Open-Angle GlaucomaNCT03931317
Study Comparing the Effects of Latanoprostene Bunod and Timolol on Retinal Blood Vessel Density and Visual Acuity
A study testing Latanoprostene bunod 0.024% QD and Timolol maleate 0.5% BID in people with OAG - Open-Angle Glaucoma and OHT - Ocular Hypertension, run by University of California, San Diego at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 40 to 90 yearsHealthy volunteers can take part
- Conditions the study is for
- OAG - Open-Angle Glaucoma, OHT - Ocular Hypertension
- What is being tested?
- Latanoprostene bunod 0.024% QD and Timolol maleate 0.5% BID
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 70 participants
- Where
- 1 siteUnited States
- Study dates
- 3 Dec 2018to 1 Mar 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 to 90 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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).
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- 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).
Trial locations and contacts
1 site in 1 country.
United States1 site
UCSD Shiley Eye Institute
La Jolla, California, 92093
About this study
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
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.
Read the 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).
- Being tested
- Latanoprostene bunod 0.024% QD, Timolol maleate 0.5% BID
- Medical subject headings
- Glaucoma, Open-Angle, Ocular Hypertension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Latanoprostene bunod 0.024% QDDrug
Also called Vyzulta
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.
Timolol maleate 0.5% BIDDrug
Also called Timoptic
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.
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: 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 Receives: Drug: Timolol maleate 0.5% BID |
What is being measured
The primary outcome is the main question the study is designed to answer.
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]).
Measured: Through study completion, an average of 11 to 19 weeks
Secondary outcomes (1)
best-corrected visual acuity (BCVA)
The secondary efficacy endpoint for this study is change in best-corrected visual acuity (BCVA)
Measured: Through study completion, an average of 11 to 19 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Apr 2019
- Study start3 Dec 2018
- Primary completion20 May 2021
- Study completion1 Mar 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for OAG - Open-Angle GlaucomaStudies of the same condition, open and under way.
- More trials run by University of California, San DiegoThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 70 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of California, San Diego
- Sponsor type
- University, hospital or other
- Collaborators
- Bausch & Lomb Incorporated
- Responsible party
- Principal investigator, Robert Weinreb, University of California, San Diego
- Investigators
- Robert Weinreb, MD, Principal investigator, UCSD Shiley Eye Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03931317
- Sponsor's protocol ID
- 180658
- Status last verified
- Aug 2023
- First submitted
- 31 Mar 2019
- Last updated
- 29 Aug 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT03931317
- Acronym / sponsor ID
- 180658
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 70 participants (actual)
- Lead sponsor
- University of California, San DiegoUniversity, hospital or other
- Collaborators
- Bausch & Lomb Incorporated
- Study start
- 3 Dec 2018 (actual)
- Primary completion
- 20 May 2021 (actual)
- Study completion
- 1 Mar 2023 (actual)
- First posted
- 30 Apr 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Latanoprostene bunod 0.024% QD | Other | Drug: Latanoprostene bunod 0.024% QD4 weeks of Latanoprostene bunod 0.024% QD, then a 2 Week washout, followed by 4 weeks of Timolol maleate 0.5% BID |
| Timolol maleate 0.5% BID | Other | Drug: Timolol maleate 0.5% BID4 weeks of Timolol maleate 0.5% BID, then a 2 Week washout, followed by 4 weeks of Latanoprostene bunod 0.024% QD |
Who may qualify
- Ages
- 40 to 90 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (26 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Latanoprostene bunod 0.024% QDAlso: VyzultaThis 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. | Drug | Latanoprostene bunod 0.024% QD |
| Timolol maleate 0.5% BIDAlso: TimopticThis 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. | Drug | Timolol maleate 0.5% BID |
Primary outcome
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]).
1 secondary outcome
best-corrected visual acuity (BCVA)
Time frame: Through study completion, an average of 11 to 19 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Aug 2023.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Robert Weinreb, MD principal investigator
UCSD Shiley Eye Institute
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Latanoprostene bunod 0.024% QD and Timolol maleate 0.5% BID in people with OAG - Open-Angle Glaucoma and OHT - Ocular Hypertension, run by University of California, San Diego at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 26 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 29 Aug 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
retinal blood vessel density (peripapillary and macular) (time frame: Through study completion, an average of 11 to 19 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Aug 2023.