Back to resultsA 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 (TAURUS)
Primary Purpose
Presbyopia
Status
Completed
Phase
Phase 3
Locations
Australia
Study Type
Interventional
Intervention
AGN-190584
Sponsored by
About this trial
This is an interventional treatment trial for Presbyopia focused on measuring Presbyopia, AGN-190584
Eligibility Criteria
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.
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.
Sites / Locations
- School of Optometry and Vision Science, Queensland University of Technology /ID# 226378
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
AGN-190584 Sequence 1
AGN-190584 Sequence 2
Arm Description
AGN-190584 Sequence 1 (Participants will receive AGN-190584 from Visit 2 through Visit 3 followed by Vehicle from Visit 4 through Visit 5).
AGN-190584 Sequence 2 (Participants will receive Vehicle from Visit 2 through Visit 3 followed by AGN-190584 from Visit 4 through Visit 5).
Outcomes
Primary Outcome Measures
Overall Composite Driving Z score approximately 1 hour after study intervention instillation
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.
Number of Participants with Adverse Events
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.
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04837482
Brief 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
Acronym
TAURUS
Official Title
Evaluating the Impact of AGN-190584 on Night-driving Performance
Study Type
Interventional
2. Study Status
Record Verification Date
November 2022
Overall Recruitment Status
Completed
Study Start Date
May 14, 2021 (Actual)
Primary Completion Date
December 7, 2021 (Actual)
Study Completion Date
December 7, 2021 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Allergan
4. Oversight
Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
Yes
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Presbyopia
Keywords
Presbyopia, AGN-190584
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Crossover Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
43 (Actual)
8. Arms, Groups, and Interventions
Arm Title
AGN-190584 Sequence 1
Arm Type
Experimental
Arm Description
AGN-190584 Sequence 1 (Participants will receive AGN-190584 from Visit 2 through Visit 3 followed by Vehicle from Visit 4 through Visit 5).
Arm Title
AGN-190584 Sequence 2
Arm Type
Experimental
Arm Description
AGN-190584 Sequence 2 (Participants will receive Vehicle from Visit 2 through Visit 3 followed by AGN-190584 from Visit 4 through Visit 5).
Intervention Type
Drug
Intervention Name(s)
AGN-190584
Intervention Description
Topical eyedrop
Primary Outcome Measure Information:
Title
Overall Composite Driving Z score approximately 1 hour after study intervention instillation
Description
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.
Time Frame
Day 8 to Day 71
Title
Number of Participants with Adverse Events
Description
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.
Time Frame
Day -30 to Day 71
10. Eligibility
Sex
All
Minimum Age & Unit of Time
40 Years
Maximum Age & Unit of Time
55 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
ALLERGAN INC.
Organizational Affiliation
Allergan
Official's Role
Study Director
Facility Information:
Facility Name
School of Optometry and Vision Science, Queensland University of Technology /ID# 226378
City
Brisbane
State/Province
Queensland
ZIP/Postal Code
4059
Country
Australia
12. IPD Sharing Statement
Plan to Share IPD
Yes
IPD Sharing Plan Description
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.
IPD Sharing Time Frame
For details on when studies are available for sharing, please refer to the link below
IPD Sharing Access Criteria
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.
IPD Sharing URL
https://vivli.org/ourmember/abbvie/
Learn more about this trial
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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