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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/ct2/show/NCT04837482




Registration number
NCT04837482
Ethics application status
Date submitted
6/04/2021
Date registered
8/04/2021
Date last updated
9/11/2022

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
Scientific title
Evaluating the Impact of AGN-190584 on Night-driving Performance
Secondary ID [1] 0 0
1883-306-013
Universal Trial Number (UTN)
Trial acronym
TAURUS
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Presbyopia 0 0
Condition category
Condition code
Eye 0 0 0 0
Diseases / disorders of the eye

Intervention/exposure
Study type
Interventional
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
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Overall Composite Driving Z score approximately 1 hour after study intervention instillation
Timepoint [1] 0 0
Day 8 to Day 71
Primary outcome [2] 0 0
Number of Participants with Adverse Events
Timepoint [2] 0 0
Day -30 to Day 71

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.
Minimum age
40 Years
Maximum age
55 Years
Sex
Both males and females
Can healthy volunteers participate?
No
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.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s


The people analysing the results/data
Intervention assignment
Crossover
Other design features
Phase
Phase 3
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
14/05/2021
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
7/12/2021
Sample size
Target
Accrual to date
Final
43
Recruitment in Australia
Recruitment state(s)
QLD
Recruitment hospital [1] 0 0
School of Optometry and Vision Science, Queensland University of Technology /ID# 226378 - Brisbane
Recruitment postcode(s) [1] 0 0
4059 - Brisbane

Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
Allergan
Address
Country

Ethics approval
Ethics application status

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.
Trial website
https://clinicaltrials.gov/ct2/show/NCT04837482
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
ALLERGAN INC.
Address 0 0
Allergan
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/ct2/show/NCT04837482