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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/study/NCT04837482
Registration number
NCT04837482
Ethics application status
Date submitted
6/04/2021
Date registered
8/04/2021
Titles & IDs
Public title
A Study to Assess the Impact and Adverse Events of Topical Eyedrops of AGN-190584 on Night-driving Performance in Participants, 40 to 55 Years of Age
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Scientific title
Evaluating the Impact of AGN-190584 on Night-driving Performance
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Secondary ID [1]
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1883-306-013
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Universal Trial Number (UTN)
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Trial acronym
TAURUS
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Presbyopia
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Condition category
Condition code
Eye
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Diseases / disorders of the eye
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Treatment: Drugs - AGN-190584
Experimental: AGN-190584 Sequence 1 - AGN-190584 Sequence 1 (Participants will receive AGN-190584 from Visit 2 through Visit 3 followed by Vehicle from Visit 4 through Visit 5).
Experimental: AGN-190584 Sequence 2 - AGN-190584 Sequence 2 (Participants will receive Vehicle from Visit 2 through Visit 3 followed by AGN-190584 from Visit 4 through Visit 5).
Treatment: Drugs: AGN-190584
Topical eyedrop
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Intervention code [1]
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Treatment: Drugs
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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Overall Composite Driving Z score approximately 1 hour after study intervention instillation
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Assessment method [1]
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An overall composite driving Z score approximately 1 hour after study intervention instillation will be derived to capture the overall driving performance of each participant compared with the whole group from the following parameters: percent hazards hit, percent sign recognition and recognition distance, pedestrian recognition distances, and percent of time outside of the lane.
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Timepoint [1]
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Day 8 to Day 71
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Primary outcome [2]
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Number of Participants with Adverse Events
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Assessment method [2]
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An adverse event (AE) is defined as any untoward medical occurrence in a patient or clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. The investigator assesses the relationship of each event to the use of the study intervention. A serious adverse event (SAE) is an event that results in death, is life threatening, requires inpatient hospitalization or prolongs an existing hospitalization, results in a congenital anomaly, persistent or significant disability/incapacity or is an important medical event, that based on medical judgment, may jeopardize the participant and may require medical or surgical intervention to prevent any of the outcomes listed above. Treatment-emergent adverse events/ treatment emergent serious adverse events (TEAEs/TESAEs) are defined as any event that began or worsened in severity on or after the first dose of the study drug.
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Timepoint [2]
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Day -30 to Day 71
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Eligibility
Key inclusion criteria
* In good general health at the screening visit, as determined by the investigator from medical history.
* Subjective complaints of poor near vision that impacts activities of daily living, as defined by at least a moderate impact (score > = 3) on at least 1 question on NEI VFQ-25 Questions 5 to 7 in the main questionnaire or near vision subscale, Questions A3 to A5 in the Appendix of Optional Additional Questions, at the screening visit. Note: Please advise the participant that for this questionnaire they are to interpret the instructions as referring to glasses or contacts they need for seeing objects at a distance (if required), not their reading glasses or bifocals.
* Photopic, high-contrast, best distance correction in the range of spherical -4.00 D to +1.00 D inclusively and cylinder < = + -2.00 D with photopic at the screening visit and photopic, high-contrast BCDVA of 20/25 or better OD and OS at the screening visit.
* Photopic, high-contrast HDVA of 20/32 or better OU at screening as well as before and 1 hour after dosing at both driving tests. Only monofocal correction (either spectacles or contact lenses) is allowed for the driving tests. If the participant does not have monofocal correction of 20/32 or better OU, the study site will provide monofocal spectacles.
* Mesopic, high-contrast DCNVA of 20/40 to 20/100 OD and OS at screening
* Photopic, high-contrast near visual acuity correctable to 20/40 or better in each eye at the screening visit.
* Mesopic pupil diameter < 8.0 mm in both eyes at the screening visit.
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Minimum age
40
Years
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Maximum age
55
Years
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Sex
Both males and females
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Can healthy volunteers participate?
No
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Key exclusion criteria
* History of cataract surgery, phakic intraocular lens surgery, corneal inlay surgery, radial keratotomy, or any intraocular surgery.
* Use of any topical ophthalmic medications, including artificial tears other than the study medications during the study.
* Use of temporary or permanent punctal plugs or history of punctal cautery in one or both eyes.
* Corneal abnormalities in either eye that are likely to interfere with visual acuity.
* Narrow iridocomeal angles, history of angle-closure glaucoma, or previous iridotomy.
* Diagnosis of any type of glaucoma or ocular hypertension.
* Females who are pregnant, nursing, or planning a pregnancy during the study.
* Uncontrolled systemic disease.
* Severe dry eye disease.
* History of iris trauma.
* Lens opacity in either eye that is determined to cause significant disturbance of the central visual axis on screening biomicroscopy.
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Study design
Purpose of the study
Treatment
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Allocation to intervention
Randomised controlled trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Blinded (masking used)
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Who is / are masked / blinded?
The people receiving the treatment/s
The people analysing the results/data
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Intervention assignment
Crossover
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Other design features
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Phase
Phase 3
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Completed
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
14/05/2021
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
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Actual
7/12/2021
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Sample size
Target
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Accrual to date
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Final
43
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Recruitment in Australia
Recruitment state(s)
QLD
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Recruitment hospital [1]
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School of Optometry and Vision Science, Queensland University of Technology /ID# 226378 - Brisbane
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Recruitment postcode(s) [1]
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4059 - Brisbane
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Funding & Sponsors
Primary sponsor type
Commercial sector/industry
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Name
Allergan
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Address
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Country
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Ethics approval
Ethics application status
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Summary
Brief summary
The purpose of this study is to evaluate night-driving performance in real-world driving conditions in participants with presbyopia treated with AGN-190584 versus vehicle. Adverse events and change in disease symptoms will be assessed. AGN-190584 is an investigational formulation of pilocarpine for treating symptoms associated with presbyopia as a topical, once-daily eyedrop delivered by a proprietary vehicle. This study consists of two parts. Part 1 consists of Visit 2 and Visit 3, and Part 2 consists of Visit 4 and Visit 5. Approximately half of the participants will receive AGN-190584 at Visit 2 through Visit 3 (Sequence 1 participants) and the remaining participants (Sequence 2 participants) will receive AGN-190584 at Visit 4 through Visit 5. All participants will receive AGN-190584 at home as instructed. Approximately 54 adult participants with presbyopia will be enrolled AT 1 site in Australia. Treatment duration is expected to be no more than 71 days. In Part 1, at Visit 2 (Day 1) and at home as instructed for 7 to 14 days Sequence 1 participants will receive 1 eyedrop of AGN-190584 in each eye and Sequence 2 participants will receive 1 eyedrop of vehicle in each eye. All participants will have a driving assessment at Visit 3 (Day 8 to 15). In Part 2, at Visit 4 (Day 15 to 57) and at home as instructed for 7 to 14 days Sequence 2 participants will receive 1 eyedrop of AGN-190584 in each eye and Sequence 1 participants will receive 1 eyedrop of vehicle in each eye. All participants will have a driving assessment at Visit 5 (Day 22 to 71). There may be higher treatment burden for participants in this trial compared to their standard of care. Participants will attend regular visits during the course of the study at a hospital or clinic. The effects of the treatment will be checked by medical assessments, asking about side effects, and completing questionnaires.
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Trial website
https://clinicaltrials.gov/study/NCT04837482
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
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ALLERGAN INC.
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Address
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Allergan
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Country
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Phone
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Fax
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Email
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Contact person for public queries
Name
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Address
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Country
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Phone
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Fax
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Email
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Contact person for scientific queries
Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
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What data in particular will be shared?
AbbVie is committed to responsible data sharing regarding the clinical trials we sponsor. This includes access to anonymized, individual and trial-level data (analysis data sets), as well as other information (e.g., protocols and clinical study reports), as long as the trials are not part of an ongoing or planned regulatory submission. This includes requests for clinical trial data for unlicensed products and indications.
Supporting document/s available: Study protocol, Statistical analysis plan (SAP), Clinical study report (CSR)
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When will data be available (start and end dates)?
For details on when studies are available for sharing, please refer to the link below
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Available to whom?
Access to this clinical trial data can be requested by any qualified researchers who engage in rigorous, independent scientific research, and will be provided following review and approval of a research proposal and Statistical Analysis Plan (SAP) and execution of a Data Use Agreement (DUA). For more information on the process, or to submit a request, visit the following link.
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Available for what types of analyses?
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How or where can data be obtained?
IPD available at link: https://vivli.org/ourmember/abbvie/
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What supporting documents are/will be available?
No Supporting Document Provided
Results publications and other study-related documents
No documents have been uploaded by study researchers.
Results not provided in
https://clinicaltrials.gov/study/NCT04837482